Trial Outcomes & Findings for ADVM-022 Intravitreal Gene Therapy for DME (NCT NCT04418427)

NCT ID: NCT04418427

Last Updated: 2025-07-10

Results Overview

Time to worsening of DME disease activity in the study eye through 96 weeks. Time to worsening of DME disease activity defined by either: An increase in CST \> 50 µm as assessed by SD-OCT compared to the lower of the two CST measurements recorded at Day 1 or Week 4; A loss of \> 5 letters in BCVA due to worsening DME disease activity compared to the higher of the two BCVA measurements recorded at Day 1 or Week 4. Number of weeks was relative to Day 1.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 36 participants
• Primary outcome timeframe: Day 1 through 96 weeks
• Results posted on: 2025-07-10

Participant Flow

Two doses of ADVM-022 (Ixo-vec) were investigated, administered with or without a prior loading dose of Aflibercept. The control group received the initial loading dose of Aflibercept (Day 1) but received a Sham injection on Day 8 instead of Ixo-vec. Only one eye was selected as the study eye. After the assigned intravitreal (IVT) injections on Days 1 and 8, clinic visits were on Weeks 2, 4, and every 4 weeks up to Week 96. Consenting participants then entered a long-term follow-up study.

Participants with initial diagnosis of DME within 6 months of screening, and who had received up to 2 prior injections of anti-VEGF therapy in the study eye (0, 1 or 2) were eligible for enrollment. If a prior anti-VEGF had been administered to the study eye, in the judgement of the Investigator, there must have been a meaningful CST response (e.g., ≥ 10% reduction) and no adverse reaction to the anti-VEGF (e.g., intraocular inflammation).

Participant milestones

Measure	ADVM-022 6E11 vg/Eye 6E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT 6E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept Aflibercept: Commercially available Active Comparator	ADVM-022 2E11 vg/Eye 2E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT 2E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept Aflibercept: Commercially available Active Comparator	Aflibercept + Sham Aflibercept 2mg IVT Aflibercept: Commercially available Active Comparator
Overall Study STARTED	13	13	10
Overall Study Modified ITT (mITT) Population	12	13	9
Overall Study COMPLETED	12	9	7
Overall Study NOT COMPLETED	1	4	3

Reasons for withdrawal

Measure	ADVM-022 6E11 vg/Eye 6E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT 6E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept Aflibercept: Commercially available Active Comparator	ADVM-022 2E11 vg/Eye 2E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT 2E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept Aflibercept: Commercially available Active Comparator	Aflibercept + Sham Aflibercept 2mg IVT Aflibercept: Commercially available Active Comparator
Overall Study Death	0	1	0
Overall Study Lost to Follow-up	0	2	2
Overall Study Subject Discontinued by the Sponsor	1	0	1
Overall Study Pre-existing medical condition	0	1	0

Baseline Characteristics

ADVM-022 Intravitreal Gene Therapy for DME

Baseline characteristics by cohort

Measure	ADVM-022 6E11 vg/Eye n=13 Participants 6E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT 6E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept Aflibercept: Commercially available Active Comparator	ADVM-022 2E11 vg/Eye n=13 Participants 2E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT 2E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept Aflibercept: Commercially available Active Comparator	Aflibercept + Sham n=10 Participants Aflibercept 2mg IVT Aflibercept: Commercially available Active Comparator	Total n=36 Participants Total of all reporting groups
Age, Continuous	62.8 Years STANDARD_DEVIATION 5.94 • n=5 Participants	60.5 Years STANDARD_DEVIATION 8.28 • n=7 Participants	56.6 Years STANDARD_DEVIATION 5.68 • n=5 Participants	60.3 Years STANDARD_DEVIATION 7.09 • n=4 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	15 Participants n=4 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	9 Participants n=7 Participants	5 Participants n=5 Participants	21 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	20 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	16 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	31 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Day 1 through 96 weeks

Population: The Modified Intent to Treat population (mITT) was analyzed for this endpoint (mITT population includes all randomized participants who received study treatment at both Day 1 \[Aflibercept or Sham\] and Day 8 \[Ixo-vec or Sham\]).

Time to worsening of DME disease activity in the study eye through 96 weeks.

Time to worsening of DME disease activity defined by either: An increase in CST > 50 µm as assessed by SD-OCT compared to the lower of the two CST measurements recorded at Day 1 or Week 4; A loss of > 5 letters in BCVA due to worsening DME disease activity compared to the higher of the two BCVA measurements recorded at Day 1 or Week 4. Number of weeks was relative to Day 1.

Outcome measures

Measure	ADVM-022 6E11 vg/Eye n=12 Study Eyes 6E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT 6E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept Aflibercept: Commercially available Active Comparator	ADVM-022 2E11 vg/Eye n=13 Study Eyes 2E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT 2E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept Aflibercept: Commercially available Active Comparator	Aflibercept + Sham n=9 Study Eyes Aflibercept 2mg IVT Aflibercept: Commercially available Active Comparator
Time to Worsening of DME Disease Activity in the Study Eye.	82.1 Weeks Interval 12.1 to The upper limit of the 90% confidence interval was not calculable because an insufficient number of participants experienced the event by the final time point for assessment.	96.1 Weeks Interval 20.6 to The upper limit of the 90% confidence interval was not calculable because an insufficient number of participants experienced the event by the final time point for assessment.	19.1 Weeks Interval 12.7 to 24.0

SECONDARY outcome

Timeframe: 96 weeks

Population: mITT population: participants who received treatment on Day 1 (aflibercept or Sham) and Day 8 (Ixo-vec or Sham) analyzed based on treatments they received on Days 1 and 8. Ocular adverse events are presented for the Study Eye only. Note: two participants who were discontinued prior to Day 8 are not included in the mITT population. These two participants reported no adverse events.

Incidence of ocular adverse events (AEs) through 96 weeks

Outcome measures

Measure	ADVM-022 6E11 vg/Eye n=12 Participants 6E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT 6E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept Aflibercept: Commercially available Active Comparator	ADVM-022 2E11 vg/Eye n=13 Participants 2E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT 2E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept Aflibercept: Commercially available Active Comparator	Aflibercept + Sham n=9 Participants Aflibercept 2mg IVT Aflibercept: Commercially available Active Comparator
Incidence of Ocular Adverse Events (AEs)	12 Participants	13 Participants	9 Participants

SECONDARY outcome

Timeframe: Day 1 through 96 weeks

Population: mITT population: participants who received treatment on Day 1 (aflibercept or Sham) and Day 8 (Ixo-vec or Sham) analyzed based on treatments they received on Days 1 and 8. Note: two participants who were discontinued prior to Day 8 are not included in the mITT population. These two participants reported no adverse events.

Incidence of non-ocular adverse events (AEs) through 96 weeks.

Outcome measures

Measure	ADVM-022 6E11 vg/Eye n=12 Participants 6E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT 6E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept Aflibercept: Commercially available Active Comparator	ADVM-022 2E11 vg/Eye n=13 Participants 2E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT 2E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept Aflibercept: Commercially available Active Comparator	Aflibercept + Sham n=9 Participants Aflibercept 2mg IVT Aflibercept: Commercially available Active Comparator
Incidence of Non-ocular Adverse Events (AEs)	9 Participants	9 Participants	7 Participants

SECONDARY outcome

Timeframe: Baseline through 96 weeks

Population: The Modified Intent to Treat population (mITT) was analyzed for this endpoint (mITT population includes all randomized participants who received study treatment at both Day 1 \[Aflibercept or Sham\] and Day 8 \[Ixo-vec or Sham\]).

Central subfield thickness is a measurement of the thickness of the retina in a circular area around the fovea. Least squares mean change from Baseline in central subfield thickness at Week 96 is presented for the study eye.

Outcome measures

Measure	ADVM-022 6E11 vg/Eye n=12 Study Eyes 6E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT 6E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept Aflibercept: Commercially available Active Comparator	ADVM-022 2E11 vg/Eye n=13 Study Eyes 2E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT 2E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept Aflibercept: Commercially available Active Comparator	Aflibercept + Sham n=9 Study Eyes Aflibercept 2mg IVT Aflibercept: Commercially available Active Comparator
Change From Baseline Central Subfield Thickness (CST) in Study Eye	-84.4 micrometers Interval -124.0 to -44.9	-129.7 micrometers Interval -172.2 to -87.3	-129.7 micrometers Interval -176.9 to -82.4

SECONDARY outcome

Timeframe: 96 weeks

Population: The Modified Intent to Treat population (mITT) was analyzed for this endpoint (mITT population includes all randomized participants who received study treatment at both Day 1 \[Aflibercept or Sham\] and Day 8 \[Ixo-vec or Sham\]).

Least squares mean change from Baseline in BCVA score over time was measured over time through week 96 in the study eye by ETDRS letters.

Outcome measures

Measure	ADVM-022 6E11 vg/Eye n=12 Study Eyes 6E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT 6E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept Aflibercept: Commercially available Active Comparator	ADVM-022 2E11 vg/Eye n=13 Study Eyes 2E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT 2E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept Aflibercept: Commercially available Active Comparator	Aflibercept + Sham n=9 Study Eyes Aflibercept 2mg IVT Aflibercept: Commercially available Active Comparator
Change From Baseline in Best Corrected Visual Acuity (BCVA) Score Over Time in the Study Eye	-11.9 ETDRS letters Interval -20.7 to -3.2	10.1 ETDRS letters Interval 0.4 to 19.8	17.1 ETDRS letters Interval 7.1 to 27.0

SECONDARY outcome

Timeframe: Day 1 through 96 weeks

Population: The Modified Intent to Treat population (mITT) was analyzed for this endpoint (mITT population includes all randomized participants who received study treatment at both Day 1 \[Aflibercept or Sham\] and Day 8 \[Ixo-vec or Sham\]).

Frequency of supplemental aflibercept (2 mg IVT) injections was assessed in the study eye over time during the study.

Participants were analyzed according to the study treatments they actually received on Days 1 and 8.

The rate of supplemental aflibercept per year = Total number of supplemental aflibercept injections / Total years at-risk (at-risk duration starting at Day 8).

Outcome measures

Measure	ADVM-022 6E11 vg/Eye n=12 Study Eyes 6E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT 6E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept Aflibercept: Commercially available Active Comparator	ADVM-022 2E11 vg/Eye n=13 Study Eyes 2E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT 2E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept Aflibercept: Commercially available Active Comparator	Aflibercept + Sham n=9 Study Eyes Aflibercept 2mg IVT Aflibercept: Commercially available Active Comparator
Frequency of Supplemental Aflibercept Injections (2 mg IVT) in the Study Eye Over Time During the Study	1.001 Injections/year Interval 0.022 to 1.979	0.423 Injections/year Interval 0.055 to 0.792	5.54 Injections/year Interval 3.058 to 8.029

SECONDARY outcome

Timeframe: From Day 1 through 96 weeks

Population: The Modified Intent to Treat population (mITT) was analyzed for this endpoint (mITT population includes all randomized participants treated on both Day 1 \[Aflibercept or Sham\] and Day 8 \[Ixo-vec or Sham\]). Only mITT participants whose Baseline Score permitted a ≥ 2 step DRSS improvement were eligible for this analysis. The incidence of 2-step improvement in DRSS score over time at Week 96 is presented.

Diabetic Retinopathy Severity Score was determined by the Central Reading Center using ultra-wide field color retinopathy fundus photography. The score represents a comprehensive evaluation of retinal health, including the presence of microaneurysms, hemorrhages, and other abnormalities in the retina of the study eye. The score ranges from 10 to 85 and is divided into 13-steps used to classify increasing diabetic retinopathy severity (with higher scored indicating more advanced stages of Diabetic Retinopathy). In this endpoint a 2-step improvement indicates an improvement in a participant across 2 steps of the 13-step scale.

Outcome measures

Measure	ADVM-022 6E11 vg/Eye n=11 Participants 6E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT 6E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept Aflibercept: Commercially available Active Comparator	ADVM-022 2E11 vg/Eye n=11 Participants 2E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT 2E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept Aflibercept: Commercially available Active Comparator	Aflibercept + Sham n=8 Participants Aflibercept 2mg IVT Aflibercept: Commercially available Active Comparator
Incidence of 2-step Improvement in Diabetic Retinopathy Severity Score (DRSS) in the Study Eye Over Time	8 Participants	8 Participants	4 Participants

SECONDARY outcome

Timeframe: From Day 1 through 96 weeks

Population: The Modified Intent to Treat population (mITT) was analyzed for this endpoint (mITT population includes all randomized participants treated on both Day 1 \[Aflibercept or Sham\] and Day 8 \[Ixo-vec or Sham\]). Only mITT participants whose Baseline Score permitted a ≥3 step DRSS improvement were eligible for this analysis. The incidence of 3-step improvement in DRSS score over time at Week 96 is presented. Visits with a 3-step or greater improvement in DRSS were considered separate events.

Diabetic Retinopathy Severity Score was determined by the Central Reading Center using ultra-wide field color retinopathy fundus photography. The score represents a comprehensive evaluation of retinal health, including the presence of microaneurysms, hemorrhages, and other abnormalities in the retina of the study eye. The score ranges from 10 to 85 and is divided into 13-steps used to classify increasing diabetic retinopathy severity (with higher scored indicating more advanced stages of Diabetic Retinopathy). In this endpoint a 3-step improvement indicates an improvement in a participant across 3 steps of the 13-step scale.

Outcome measures

Measure	ADVM-022 6E11 vg/Eye n=8 Participants 6E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT 6E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept Aflibercept: Commercially available Active Comparator	ADVM-022 2E11 vg/Eye n=8 Participants 2E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT 2E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept Aflibercept: Commercially available Active Comparator	Aflibercept + Sham n=5 Participants Aflibercept 2mg IVT Aflibercept: Commercially available Active Comparator
Incidence of 3-step Improvement in DRSS (Diabetic Retinopathy Severity Score) in the Study Eye Over Time	3 Participants	4 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day 1 through 96 weeks

Population: The Modified Intent to Treat population (mITT) was analyzed for this endpoint (mITT population includes all randomized participants who received study treatment at both Day 1 \[Aflibercept or Sham\] and Day 8 \[Ixo-vec or Sham\]). The incidence of 2-step worsening in DRSS score over time at Week 96 is presented. Visits with a 2-step or greater worsening in DRSS were considered separate events.

Diabetic Retinopathy Severity Score was determined by the Central Reading Center using ultra-wide field color retinopathy fundus photography. The score represents a comprehensive evaluation of retinal health, including the presence of microaneurysms, hemorrhages, and other abnormalities in the retina of the study eye. The score ranges from 10 to 85 and is divided into 13-steps used to classify increasing diabetic retinopathy severity (with higher scored indicating more advanced stages of Diabetic Retinopathy). In this endpoint a 2-step worsening indicates a worsening across 2 steps of the 13-step scale.

Note: 2-step worsening in DRSS was observed in 2 participants in both the control arm and the ADVM-022 6E11 vg/eye arm. These participants experienced ocular adverse events which may have contributed, at least in part, to the worsening in DRSS. This included one participant in the ADVM-022 6E11 vg/eye arm who had a SUSAR of Hypotony of eye (secondary to intraocular inflammation).

Outcome measures

Measure	ADVM-022 6E11 vg/Eye n=12 Participants 6E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT 6E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept Aflibercept: Commercially available Active Comparator	ADVM-022 2E11 vg/Eye n=13 Participants 2E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT 2E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept Aflibercept: Commercially available Active Comparator	Aflibercept + Sham n=9 Participants Aflibercept 2mg IVT Aflibercept: Commercially available Active Comparator
Incidence of 2-step Worsening in DRSS (Diabetic Retinopathy Severity Score) in the Study Eye Over Time	2 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: From Day 1 through 96 weeks

Population: The Modified Intent to Treat population (mITT) was analyzed for this endpoint (mITT population includes all randomized participants who received study treatment at both Day 1 \[Aflibercept or Sham\] and Day 8 \[Ixo-vec or Sham\]).

Diabetic Retinopathy Severity Score was determined by the Central Reading Center using ultra-wide field color retinopathy fundus photography. The score represents a comprehensive evaluation of retinal health, including the presence of microaneurysms, hemorrhages, and other abnormalities in the retina of the study eye. The score ranges from 10 to 85 with higher scored indicating more advanced stages of Diabetic Retinopathy. The incidence of 3-step worsening in DRSS score over time at Week 96 is presented. Visits with a 3-step or greater worsening in DRSS were considered separate events.

Note: 3-step worsening in DRSS was observed in one participant each in the control arm and the ADVM-022 6E11 vg/eye arm. Both participants experienced ocular adverse events which may have contributed, at least in part, to the worsening in DRSS. This included one participant in the ADVM-022 6E11 vg/eye arm who had a SUSAR of Hypotony of eye (secondary to intraocular inflammation).

Outcome measures

Measure	ADVM-022 6E11 vg/Eye n=12 Participants 6E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT 6E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept Aflibercept: Commercially available Active Comparator	ADVM-022 2E11 vg/Eye n=13 Participants 2E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT 2E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept Aflibercept: Commercially available Active Comparator	Aflibercept + Sham n=9 Participants Aflibercept 2mg IVT Aflibercept: Commercially available Active Comparator
Incidence of 3-step Worsening in DRSS (Diabetic Retinopathy Severity Score) in the Study Eye Over Time	1 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: From Day 1 through 96 weeks

Population: The Modified Intent to Treat population (mITT) was analyzed for this endpoint (mITT population includes all randomized participants who received study treatment at both Day 1 \[Aflibercept or Sham\] and Day 8 \[Ixo-vec or Sham\]).

Occurrence of any vision threatening complication over time though 96 weeks. Results present the incidence of participants who experienced "Any Vision Threatening Complications" (defined as any Vitreous Haemorrhage adverse event (AE), Anterior Segment Neovascularization AE, High-risk proliferative DR (defined as DSSR >= 71), or Tractional Retinal Detachment AE) in the study eye from Day 1 through 96 weeks.

Note: AEs of Vitreous Haemorrhage and High-risk proliferative DR were reported in 1 participant in the control arm and in 2 separate participants in the 6E11 vg/eye arm. No AE of Tractional Retinal Detachment or Anterior Segment Neovascularization occurred.

Outcome measures

Measure	ADVM-022 6E11 vg/Eye n=12 Participants 6E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT 6E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept Aflibercept: Commercially available Active Comparator	ADVM-022 2E11 vg/Eye n=13 Participants 2E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT 2E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept Aflibercept: Commercially available Active Comparator	Aflibercept + Sham n=9 Participants Aflibercept 2mg IVT Aflibercept: Commercially available Active Comparator
Occurrence of Any Vision Threatening Complications in the Study Eye (Anterior Segment Neovascularization, Vitreous Hemorrhage, or Any Other High-risk Proliferative DR, or Tractional Retinal Detachment) Over Time Through Week 96	2 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Day 1 through 96 weeks

Population: The Modified Intent to Treat population (mITT) was analyzed for this endpoint (mITT population includes all randomized participants who received study treatment at both Day 1 \[Aflibercept or Sham\] and Day 8 \[Ixo-vec or Sham\]). Incidence through last visit represent the last visit through Week 96 with non-missing CST data.

Central subfield thickness is a measurement of the thickness of the retina in a circular area around the fovea. Incidence of participants with Central subfield thickness of less than 300 μm over time in the study eye through Week 96 is presented.

Outcome measures

Measure	ADVM-022 6E11 vg/Eye n=12 Participants 6E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT 6E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept Aflibercept: Commercially available Active Comparator	ADVM-022 2E11 vg/Eye n=13 Participants 2E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT 2E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept Aflibercept: Commercially available Active Comparator	Aflibercept + Sham n=9 Participants Aflibercept 2mg IVT Aflibercept: Commercially available Active Comparator
Incidence of CST <300 μm Over Time Through Week 96 in the Study Eye	8 Participants	6 Participants	4 Participants

Adverse Events

ADVM-022 6E11 vg/Eye

Serious events: 9 serious events

Other events: 12 other events

Deaths: 0 deaths

ADVM-022 2E11 vg/Eye

Serious events: 8 serious events

Other events: 13 other events

Deaths: 1 deaths

Aflibercept + Sham

Serious events: 4 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	ADVM-022 6E11 vg/Eye n=12 participants at risk 6E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT 6E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept Aflibercept: Commercially available Active Comparator	ADVM-022 2E11 vg/Eye n=13 participants at risk 2E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT 2E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept Aflibercept: Commercially available Active Comparator	Aflibercept + Sham n=9 participants at risk Aflibercept 2mg IVT Aflibercept: Commercially available Active Comparator
Cardiac disorders Coronary artery stenosis	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Cardiac disorders Acute myocardial infarction	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Cardiac disorders Bradycardia	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Cardiac disorders Cardiac failure acute	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	11.1% 1/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Cardiac disorders Cardiac failure chronic	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Cardiac disorders Cardiac failure congestive	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Cataract	33.3% 4/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	15.4% 2/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	11.1% 1/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Cataract subcapsular	16.7% 2/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	23.1% 3/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Visual impairment	33.3% 4/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Hypotony of eye	25.0% 3/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Iridocyclitis	16.7% 2/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Angle closure glaucoma	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Cataract nuclear	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Choroidal effusion	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Cystoid macular oedema	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	11.1% 1/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Vitritis	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Gastrointestinal disorders Diabetic gastroparesis	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
General disorders Chest pain	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Infections and infestations Cholecystitis infective	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Infections and infestations Gangrene	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Infections and infestations Localised infection	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	11.1% 1/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Infections and infestations Osteomyelitis acute	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Metabolism and nutrition disorders Failure to thrive	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Nervous system disorders Carotid artery occlusion	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Nervous system disorders Diabetic neuropathy	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	11.1% 1/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Psychiatric disorders Depression	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Renal and urinary disorders Acute kidney injury	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	15.4% 2/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	11.1% 1/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Renal and urinary disorders Nephrolithiasis	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Skin and subcutaneous tissue disorders Diabetic foot	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Vascular disorders Deep vein thrombosis	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Vascular disorders Hypertensive emergency	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Vascular disorders Orthostatic hypotension	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Vascular disorders Peripheral artery occlusion	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	11.1% 1/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).

Other adverse events

Measure	ADVM-022 6E11 vg/Eye n=12 participants at risk 6E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT 6E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept Aflibercept: Commercially available Active Comparator	ADVM-022 2E11 vg/Eye n=13 participants at risk 2E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT 2E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept Aflibercept: Commercially available Active Comparator	Aflibercept + Sham n=9 participants at risk Aflibercept 2mg IVT Aflibercept: Commercially available Active Comparator
Blood and lymphatic system disorders Anaemia	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	15.4% 2/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Blood and lymphatic system disorders Leukocytosis	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Blood and lymphatic system disorders Abdominal lymphadenopathy	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Cardiac disorders Angina pectoris	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Cardiac disorders Tachycardia	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Ear and labyrinth disorders Deafness	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	11.1% 1/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Endocrine disorders Hypothyroidism	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	11.1% 1/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Iridocyclitis	58.3% 7/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	46.2% 6/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Anterior chamber cell	50.0% 6/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	30.8% 4/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	33.3% 3/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Iris transillumination defect	66.7% 8/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	30.8% 4/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Iris adhesions	50.0% 6/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	38.5% 5/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Ocular hypertension	25.0% 3/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	23.1% 3/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	44.4% 4/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Conjunctival haemorrhage	41.7% 5/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	23.1% 3/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	22.2% 2/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Diabetic retinal oedema	33.3% 4/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	23.1% 3/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	33.3% 3/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Pigment dispersion syndrome	25.0% 3/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	23.1% 3/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Cataract	33.3% 4/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	15.4% 2/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Keratic precipitates	16.7% 2/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	23.1% 3/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Vitreous floaters	33.3% 4/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Cataract subcapsular	33.3% 4/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Iris hyperpigmentation	16.7% 2/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	23.1% 3/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Iritis	16.7% 2/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	23.1% 3/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Uveitis	25.0% 3/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	15.4% 2/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Decrease in intraocular pressure	25.0% 3/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Corneal striae	25.0% 3/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Punctate keratitis	25.0% 3/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Anterior chamber flare	16.7% 2/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	11.1% 1/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Lenticular pigmentation	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	15.4% 2/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Vitreous detachment	16.7% 2/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Corneal oedema	16.7% 2/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Flat anterior chamber of eye	16.7% 2/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Iris atrophy	16.7% 2/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Mydriasis	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Posterior capsule opacification	16.7% 2/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Vitreous haemorrhage	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	11.1% 1/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Vitreous opacities	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Ocular hypotension	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Vision blurred	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	11.1% 1/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Cataract nuclear	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Chalazion	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Ciliary body disorder	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Conjunctivitis allergic	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Corneal erosion	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Diabetic retinopathy	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Epiretinal membrane	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Eyelid margin crusting	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Eyelid ptosis	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Foreign body sensation in eyes	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Hypotony	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Hypotony maculopathy	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders IOP 5mmHG Post injection	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	11.1% 1/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Narrow anterior chamber angle	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	11.1% 1/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Ocular discomfort	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Periorbital oedema	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Periorbital pain	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Photophobia	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Swelling of eyelid	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Visual impairment	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Vitreal cells	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Vitreoretinal traction syndrome	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Eye disorders Vitreous haze	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Gastrointestinal disorders Toothache	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	11.1% 1/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Gastrointestinal disorders Abdominal pain	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Gastrointestinal disorders Diverticulum intestinal	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Gastrointestinal disorders Hiatus hernia	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
General disorders Chest discomfort	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
General disorders Oedema peripheral	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
General disorders Peripheral swelling	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	11.1% 1/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Hepatobiliary disorders Cholelithiasis	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Hepatobiliary disorders Gallbladder polyp	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Infections and infestations COVID-19	25.0% 3/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	33.3% 3/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Infections and infestations Urinary tract infection	16.7% 2/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	11.1% 1/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Infections and infestations Chronic sinusitis	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Infections and infestations Eye infection	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Infections and infestations Pneumonia	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	11.1% 1/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Infections and infestations Pyelonephritis	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Infections and infestations Sinusitis	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Infections and infestations Urinary tract infection staphylococcal	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Injury, poisoning and procedural complications Contusion	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	22.2% 2/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Injury, poisoning and procedural complications Corneal abrasion	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Injury, poisoning and procedural complications Foot fracture	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	11.1% 1/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Injury, poisoning and procedural complications Hyphaema	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Injury, poisoning and procedural complications Toxicity to various agents	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Investigations Intraocular pressure increased	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	11.1% 1/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Metabolism and nutrition disorders Diabetes mellitus	33.3% 4/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Metabolism and nutrition disorders Dehydration	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Metabolism and nutrition disorders Hypercholesterolaemia	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Metabolism and nutrition disorders Hyperglycaemia	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	11.1% 1/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	11.1% 1/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Musculoskeletal and connective tissue disorders Degenerative bone disease	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Musculoskeletal and connective tissue disorders Fibromyalgia	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	11.1% 1/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	11.1% 1/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenal adenoma	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	11.1% 1/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Nervous system disorders Diabetic neuropathy	16.7% 2/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	11.1% 1/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Nervous system disorders Headache	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	11.1% 1/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Nervous system disorders Cerebral ventricle dilatation	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Nervous system disorders Presyncope	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	11.1% 1/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Nervous system disorders Syncope	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Product Issues Device dislocation	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Renal and urinary disorders Acute kidney injury	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Renal and urinary disorders Chronic kidney disease	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Renal and urinary disorders Hydronephrosis	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Renal and urinary disorders Nephrolithiasis	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Renal and urinary disorders Renal atrophy	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Renal and urinary disorders Renal cyst	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Reproductive system and breast disorders Pelvic fluid collection	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	11.1% 1/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Respiratory, thoracic and mediastinal disorders Lung opacity	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Skin and subcutaneous tissue disorders Diabetic foot	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Skin and subcutaneous tissue disorders Ecchymosis	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Vascular disorders Hypertension	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	33.3% 3/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Vascular disorders Aortic arteriosclerosis	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	7.7% 1/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Vascular disorders Hypotension	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Vascular disorders Peripheral arterial occlusive disease	8.3% 1/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Gastrointestinal disorders Gastrooesophageal hypot disease	0.00% 0/12 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	15.4% 2/13 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).	0.00% 0/9 • Adverse event data are presented from study treatment on Day 1 through Week 96. The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).

Additional Information

Study Medical Director

Adverum Biotechnologies

Phone: 650-656-9323

Email: clinicaltrials@adverum.com

Results disclosure agreements

• Principal investigator is a sponsor employee Investigators agreed to postponement of single-site study publications until after publication of all multi-center study results, until notification by the Sponsor that a multi-center publication is not planned, or until eighteen (18) months after final database lock.
• Publication restrictions are in place

Restriction type: OTHER