Trial Outcomes & Findings for A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME) (NCT NCT04603937)

Last Updated: 2024-08-22

Results Overview

Mean change in best-corrected visual acuity (BCVA) from baseline to the average of Weeks 60 and 64 (using Early Treatment Diabetic Retinopathy Study (ETDRS) Letters). Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

459 participants

Primary outcome timeframe

Day 1 to Week 64

Results posted on

2024-08-22

Participant Flow

Participants were recruited based on physician referral at 75 medical centers between September 2020 and January 2022. The first participant was enrolled on 30 September 2020 and the last on 31 January 2022.

Of 689 screened participants, 459 met eligibility criteria and were randomized to treatment. Two randomized subjects in KSI-301 arm never received treatment, so do not have reason for not completing treatment. Each participant contributed only one study eye to this study.

Participant milestones

Participant milestones
Measure	KSI-301 (Arm A) Intravitreal injection of KSI-301 (5 mg) once every 4 weeks for 3 monthly doses followed by an individualized dosing regimen (every 8 to 24 weeks) via intravitreal injection from Week 16 to Week 100. KSI-301: Intravitreal Injection Sham Procedure: The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.	Aflibercept (Arm B) Intravitreal injection of aflibercept (2 mg) once every 4 weeks for 5 monthly doses followed by aflibercept (2 mg) once every 8 weeks via intravitreal injection from Week 24 to 100. Aflibercept: Intravitreal Injection Sham Procedure: The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.
Overall Study STARTED	229	228
Overall Study COMPLETED	208	204
Overall Study NOT COMPLETED	21	24

Reasons for withdrawal

Reasons for withdrawal
Measure	KSI-301 (Arm A) Intravitreal injection of KSI-301 (5 mg) once every 4 weeks for 3 monthly doses followed by an individualized dosing regimen (every 8 to 24 weeks) via intravitreal injection from Week 16 to Week 100. KSI-301: Intravitreal Injection Sham Procedure: The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.	Aflibercept (Arm B) Intravitreal injection of aflibercept (2 mg) once every 4 weeks for 5 monthly doses followed by aflibercept (2 mg) once every 8 weeks via intravitreal injection from Week 24 to 100. Aflibercept: Intravitreal Injection Sham Procedure: The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.
Overall Study Adverse Event	9	10
Overall Study Withdrawal by Subject	7	6
Overall Study Lost to Follow-up	5	6
Overall Study Physician Decision	0	1
Overall Study Subject did not meet inclusion criteria 1 so was withdrawn from the study	0	1

Baseline Characteristics

A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	KSI-301 (Arm A) n=229 Participants Intravitreal injection of KSI-301 (5 mg) once every 4 weeks for 3 monthly doses followed by an individualized dosing regimen (every 8 to 24 weeks) via intravitreal injection from Week 16 to Week 100. KSI-301: Intravitreal Injection Sham Procedure: The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.	Aflibercept (Arm B) n=228 Participants Intravitreal injection of aflibercept (2 mg) once every 4 weeks for 5 monthly doses followed by aflibercept (2 mg) once every 8 weeks via intravitreal injection from Week 24 to 100. Aflibercept: Intravitreal Injection Sham Procedure: The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.	Total n=457 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	133 Participants n=5 Participants	137 Participants n=7 Participants	270 Participants n=5 Participants
Age, Categorical >=65 years	96 Participants n=5 Participants	91 Participants n=7 Participants	187 Participants n=5 Participants
Age, Continuous	62.2 years STANDARD_DEVIATION 9.34 • n=5 Participants	61.6 years STANDARD_DEVIATION 9.90 • n=7 Participants	61.9 years STANDARD_DEVIATION 9.62 • n=5 Participants
Sex: Female, Male Female	97 Participants n=5 Participants	79 Participants n=7 Participants	176 Participants n=5 Participants
Sex: Female, Male Male	132 Participants n=5 Participants	149 Participants n=7 Participants	281 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	42 Participants n=5 Participants	58 Participants n=7 Participants	100 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	182 Participants n=5 Participants	161 Participants n=7 Participants	343 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 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
Race (NIH/OMB) Black or African American	22 Participants n=5 Participants	12 Participants n=7 Participants	34 Participants n=5 Participants
Race (NIH/OMB) White	194 Participants n=5 Participants	201 Participants n=7 Participants	395 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Geographic Region North America	149 Participants n=5 Participants	147 Participants n=7 Participants	296 Participants n=5 Participants
Geographic Region Rest of World	80 Participants n=5 Participants	81 Participants n=7 Participants	161 Participants n=5 Participants
BCVA in the Study Eye, Letters	64.2 Letters STANDARD_DEVIATION 11.43 • n=5 Participants	64.3 Letters STANDARD_DEVIATION 11.21 • n=7 Participants	64.2 Letters STANDARD_DEVIATION 11.31 • n=5 Participants

PRIMARY outcome

Timeframe: Day 1 to Week 64

Population: Full analysis set defined as all randomized subjects who received any study treatment (KSI-301 or aflibercept). Subjects will be analyzed according to their randomized treatment.

Outcome measures

Outcome measures
Measure	KSI-301 (Arm A) n=229 Participants Intravitreal injection of KSI-301 (5 mg) once every 4 weeks for 3 monthly doses followed by an individualized dosing regimen (every 8 to 24 weeks) via intravitreal injection from Week 16 to Week 100. KSI-301: Intravitreal Injection Sham Procedure: The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.	Aflibercept (Arm B) n=228 Participants Intravitreal injection of aflibercept (2 mg) once every 4 weeks for 5 monthly doses followed by aflibercept (2 mg) once every 8 weeks via intravitreal injection from Week 24 to 100. Aflibercept: Intravitreal Injection Sham Procedure: The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.
Mean Change in BCVA	6.7 ETDRS Letters Standard Error 0.80	11.5 ETDRS Letters Standard Error 0.81

SECONDARY outcome

Timeframe: Day 1 to Week 52

Population: All randomized subjects in Studies KS301P104 and KS301P105 who received any study treatment (KSI-301 or aflibercept) with evaluable results at baseline and evaluable results on or prior to Week 52. The population for studies KS301P104 and KS301P105 are identical in terms of treatment indication and inclusion/exclusion criteria. Please refer to NCT04611152 to review demographics, other study details and adverse events for participants in KS301P104 study.

Percentage of patients with a ≥ 2-step worsening on the Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) from baseline at Week 52 using last observation carried forward (LOCF) in Studies KS301P104 and KS301P105 combined. The Diabetic Retinopathy Disease Severity Scale (DRSS) may be used to describe overall retinopathy severity as well as the change in severity over time. Severity range from level 10 (DR absent) to level 85 (advanced proliferative DR: posterior fundus obscured, or center of macula detached).

Outcome measures

Outcome measures
Measure	KSI-301 (Arm A) n=433 Participants Intravitreal injection of KSI-301 (5 mg) once every 4 weeks for 3 monthly doses followed by an individualized dosing regimen (every 8 to 24 weeks) via intravitreal injection from Week 16 to Week 100. KSI-301: Intravitreal Injection Sham Procedure: The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.	Aflibercept (Arm B) n=437 Participants Intravitreal injection of aflibercept (2 mg) once every 4 weeks for 5 monthly doses followed by aflibercept (2 mg) once every 8 weeks via intravitreal injection from Week 24 to 100. Aflibercept: Intravitreal Injection Sham Procedure: The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.
Percentage of Patients With a ≥ 2-step Worsening on the ETDRS DRSS in Studies KS301P104 and KS301P105 Combined	6 Participants	3 Participants

SECONDARY outcome

Timeframe: Day 1 to Week 52

Population: All randomized subjects who received any study treatment (KSI-301 or aflibercept) with evaluable results at baseline and evaluable results on or prior to Week 52.

Percentage of patients with a ≥ 2-step worsening on the Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) from baseline at Week 52 using last observation carried forward (LOCF) in Study KS301P105. The Diabetic Retinopathy Disease Severity Scale (DRSS) may be used to describe overall retinopathy severity as well as the change in severity over time. Severity range from level 10 (DR absent) to level 85 (advanced proliferative DR: posterior fundus obscured, or center of macula detached).

Outcome measures

Outcome measures
Measure	KSI-301 (Arm A) n=218 Participants Intravitreal injection of KSI-301 (5 mg) once every 4 weeks for 3 monthly doses followed by an individualized dosing regimen (every 8 to 24 weeks) via intravitreal injection from Week 16 to Week 100. KSI-301: Intravitreal Injection Sham Procedure: The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.	Aflibercept (Arm B) n=218 Participants Intravitreal injection of aflibercept (2 mg) once every 4 weeks for 5 monthly doses followed by aflibercept (2 mg) once every 8 weeks via intravitreal injection from Week 24 to 100. Aflibercept: Intravitreal Injection Sham Procedure: The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.
Percentage of Patients With a ≥ 2-step Worsening on the ETDRS DRSS in Study KS301P105	6 Participants	3 Participants

SECONDARY outcome

Timeframe: Week 56

Population: Analyses include KSI-301 patients who completed a treatment interval from Week 56 onwards.

Percentage of patients in the KSI-301 arm on a Q8W, Q12W, Q16W, Q20W, or Q24W treatment interval at the primary endpoint. Analyses include KSI-301 patients who completed a treatment interval from Week 56 onwards.

Outcome measures

Outcome measures
Measure	KSI-301 (Arm A) n=210 Participants Intravitreal injection of KSI-301 (5 mg) once every 4 weeks for 3 monthly doses followed by an individualized dosing regimen (every 8 to 24 weeks) via intravitreal injection from Week 16 to Week 100. KSI-301: Intravitreal Injection Sham Procedure: The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.	Aflibercept (Arm B) Intravitreal injection of aflibercept (2 mg) once every 4 weeks for 5 monthly doses followed by aflibercept (2 mg) once every 8 weeks via intravitreal injection from Week 24 to 100. Aflibercept: Intravitreal Injection Sham Procedure: The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.
Percentage of Patients in the KSI-301 Arm on a Q8W, Q12W, Q16W, Q20W, or Q24W Treatment Interval Number of participants on the KSI-301 Q8W	54 Participants	—
Percentage of Patients in the KSI-301 Arm on a Q8W, Q12W, Q16W, Q20W, or Q24W Treatment Interval Number of participants on the KSI-301 Q12W	23 Participants	—
Percentage of Patients in the KSI-301 Arm on a Q8W, Q12W, Q16W, Q20W, or Q24W Treatment Interval Number of participants on the KSI-301 Q16W	14 Participants	—
Percentage of Patients in the KSI-301 Arm on a Q8W, Q12W, Q16W, Q20W, or Q24W Treatment Interval Number of participants on the KSI-301 Q20W	10 Participants	—
Percentage of Patients in the KSI-301 Arm on a Q8W, Q12W, Q16W, Q20W, or Q24W Treatment Interval Number of participants on the KSI-301 Q24W	109 Participants	—

SECONDARY outcome

Timeframe: Day 1 to Week 60

Population: Safety Analysis Set includes all patients who received any study treatment (KSI-301 or aflibercept). Patients will be analyzed according to the study treatment they actually received. One patient was randomized to KSI-301, but received aflibercept.

Mean number of intravitreal injections from Day 1 to Week 60

Outcome measures

Outcome measures
Measure	KSI-301 (Arm A) n=228 Participants Intravitreal injection of KSI-301 (5 mg) once every 4 weeks for 3 monthly doses followed by an individualized dosing regimen (every 8 to 24 weeks) via intravitreal injection from Week 16 to Week 100. KSI-301: Intravitreal Injection Sham Procedure: The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.	Aflibercept (Arm B) n=229 Participants Intravitreal injection of aflibercept (2 mg) once every 4 weeks for 5 monthly doses followed by aflibercept (2 mg) once every 8 weeks via intravitreal injection from Week 24 to 100. Aflibercept: Intravitreal Injection Sham Procedure: The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.
Mean Number of Intravitreal Injections	5.8 injections Standard Deviation 1.64	9.2 injections Standard Deviation 1.91

SECONDARY outcome

Timeframe: Day 1 to Week 64

Population: Full analysis set defined as all randomized subjects who received any study treatment (KSI-301 or aflibercept). Subjects will be analyzed according to their randomized treatment.

Mean change in Optical Coherence Tomography (OCT) central subfield retinal thickness (CST) baseline to the average of Weeks 60 and 64

Outcome measures

Outcome measures
Measure	KSI-301 (Arm A) n=229 Participants Intravitreal injection of KSI-301 (5 mg) once every 4 weeks for 3 monthly doses followed by an individualized dosing regimen (every 8 to 24 weeks) via intravitreal injection from Week 16 to Week 100. KSI-301: Intravitreal Injection Sham Procedure: The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.	Aflibercept (Arm B) n=228 Participants Intravitreal injection of aflibercept (2 mg) once every 4 weeks for 5 monthly doses followed by aflibercept (2 mg) once every 8 weeks via intravitreal injection from Week 24 to 100. Aflibercept: Intravitreal Injection Sham Procedure: The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.
Mean Change in OCT CST	-154.7 Microns Standard Deviation 128.03	-194.2 Microns Standard Deviation 154.44

Adverse Events

KSI-301 (Arm A)

Serious events: 53 serious events

Other events: 113 other events

Deaths: 4 deaths

Aflibercept (Arm B)

Serious events: 57 serious events

Other events: 104 other events

Deaths: 6 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	KSI-301 (Arm A) n=228 participants at risk Intravitreal injection of KSI-301 (5 mg) once every 4 weeks for 3 monthly doses followed by an individualized dosing regimen (every 8 to 24 weeks) via intravitreal injection from Week 16 to Week 100. KSI-301: Intravitreal Injection Sham Procedure: The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.	Aflibercept (Arm B) n=229 participants at risk Intravitreal injection of aflibercept (2 mg) once every 4 weeks for 5 monthly doses followed by aflibercept (2 mg) once every 8 weeks via intravitreal injection from Week 24 to 100. Aflibercept: Intravitreal Injection Sham Procedure: The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.
Eye disorders Cataract - Study Eye	14.5% 33/228 • Number of events 34 • Time Frame Adverse Events (AEs) reported through Week 64 or Early Termination (ET) if occurred before Week 64. One subject randomized to KSI-301 treatment arm received incorrect treatment of Aflibercept, so was included in the Aflibercept treatment arm for safety analyses. Therefore, for adverse event reporting, there are 228 subjects in KSI-301 treatment arm and 229 subjects in Aflibercept treatment arm.	6.6% 15/229 • Number of events 15 • Time Frame Adverse Events (AEs) reported through Week 64 or Early Termination (ET) if occurred before Week 64. One subject randomized to KSI-301 treatment arm received incorrect treatment of Aflibercept, so was included in the Aflibercept treatment arm for safety analyses. Therefore, for adverse event reporting, there are 228 subjects in KSI-301 treatment arm and 229 subjects in Aflibercept treatment arm.
Eye disorders Conjunctival haemorrhage - Study Eye	9.6% 22/228 • Number of events 25 • Time Frame Adverse Events (AEs) reported through Week 64 or Early Termination (ET) if occurred before Week 64. One subject randomized to KSI-301 treatment arm received incorrect treatment of Aflibercept, so was included in the Aflibercept treatment arm for safety analyses. Therefore, for adverse event reporting, there are 228 subjects in KSI-301 treatment arm and 229 subjects in Aflibercept treatment arm.	3.5% 8/229 • Number of events 10 • Time Frame Adverse Events (AEs) reported through Week 64 or Early Termination (ET) if occurred before Week 64. One subject randomized to KSI-301 treatment arm received incorrect treatment of Aflibercept, so was included in the Aflibercept treatment arm for safety analyses. Therefore, for adverse event reporting, there are 228 subjects in KSI-301 treatment arm and 229 subjects in Aflibercept treatment arm.
Eye disorders Diabetic retinal oedema - Fellow Eye	6.1% 14/228 • Number of events 16 • Time Frame Adverse Events (AEs) reported through Week 64 or Early Termination (ET) if occurred before Week 64. One subject randomized to KSI-301 treatment arm received incorrect treatment of Aflibercept, so was included in the Aflibercept treatment arm for safety analyses. Therefore, for adverse event reporting, there are 228 subjects in KSI-301 treatment arm and 229 subjects in Aflibercept treatment arm.	10.5% 24/229 • Number of events 25 • Time Frame Adverse Events (AEs) reported through Week 64 or Early Termination (ET) if occurred before Week 64. One subject randomized to KSI-301 treatment arm received incorrect treatment of Aflibercept, so was included in the Aflibercept treatment arm for safety analyses. Therefore, for adverse event reporting, there are 228 subjects in KSI-301 treatment arm and 229 subjects in Aflibercept treatment arm.
Eye disorders Cataract - Fellow Eye	5.3% 12/228 • Number of events 12 • Time Frame Adverse Events (AEs) reported through Week 64 or Early Termination (ET) if occurred before Week 64. One subject randomized to KSI-301 treatment arm received incorrect treatment of Aflibercept, so was included in the Aflibercept treatment arm for safety analyses. Therefore, for adverse event reporting, there are 228 subjects in KSI-301 treatment arm and 229 subjects in Aflibercept treatment arm.	5.2% 12/229 • Number of events 12 • Time Frame Adverse Events (AEs) reported through Week 64 or Early Termination (ET) if occurred before Week 64. One subject randomized to KSI-301 treatment arm received incorrect treatment of Aflibercept, so was included in the Aflibercept treatment arm for safety analyses. Therefore, for adverse event reporting, there are 228 subjects in KSI-301 treatment arm and 229 subjects in Aflibercept treatment arm.
Eye disorders Diabetic retinal oedema - Study Eye	5.3% 12/228 • Number of events 15 • Time Frame Adverse Events (AEs) reported through Week 64 or Early Termination (ET) if occurred before Week 64. One subject randomized to KSI-301 treatment arm received incorrect treatment of Aflibercept, so was included in the Aflibercept treatment arm for safety analyses. Therefore, for adverse event reporting, there are 228 subjects in KSI-301 treatment arm and 229 subjects in Aflibercept treatment arm.	1.7% 4/229 • Number of events 5 • Time Frame Adverse Events (AEs) reported through Week 64 or Early Termination (ET) if occurred before Week 64. One subject randomized to KSI-301 treatment arm received incorrect treatment of Aflibercept, so was included in the Aflibercept treatment arm for safety analyses. Therefore, for adverse event reporting, there are 228 subjects in KSI-301 treatment arm and 229 subjects in Aflibercept treatment arm.
Infections and infestations COVID-19	14.0% 32/228 • Number of events 33 • Time Frame Adverse Events (AEs) reported through Week 64 or Early Termination (ET) if occurred before Week 64. One subject randomized to KSI-301 treatment arm received incorrect treatment of Aflibercept, so was included in the Aflibercept treatment arm for safety analyses. Therefore, for adverse event reporting, there are 228 subjects in KSI-301 treatment arm and 229 subjects in Aflibercept treatment arm.	14.8% 34/229 • Number of events 34 • Time Frame Adverse Events (AEs) reported through Week 64 or Early Termination (ET) if occurred before Week 64. One subject randomized to KSI-301 treatment arm received incorrect treatment of Aflibercept, so was included in the Aflibercept treatment arm for safety analyses. Therefore, for adverse event reporting, there are 228 subjects in KSI-301 treatment arm and 229 subjects in Aflibercept treatment arm.
Metabolism and nutrition disorders Diabetes mellitus	9.6% 22/228 • Number of events 23 • Time Frame Adverse Events (AEs) reported through Week 64 or Early Termination (ET) if occurred before Week 64. One subject randomized to KSI-301 treatment arm received incorrect treatment of Aflibercept, so was included in the Aflibercept treatment arm for safety analyses. Therefore, for adverse event reporting, there are 228 subjects in KSI-301 treatment arm and 229 subjects in Aflibercept treatment arm.	9.6% 22/229 • Number of events 23 • Time Frame Adverse Events (AEs) reported through Week 64 or Early Termination (ET) if occurred before Week 64. One subject randomized to KSI-301 treatment arm received incorrect treatment of Aflibercept, so was included in the Aflibercept treatment arm for safety analyses. Therefore, for adverse event reporting, there are 228 subjects in KSI-301 treatment arm and 229 subjects in Aflibercept treatment arm.
Vascular disorders Hypertension	10.1% 23/228 • Number of events 24 • Time Frame Adverse Events (AEs) reported through Week 64 or Early Termination (ET) if occurred before Week 64. One subject randomized to KSI-301 treatment arm received incorrect treatment of Aflibercept, so was included in the Aflibercept treatment arm for safety analyses. Therefore, for adverse event reporting, there are 228 subjects in KSI-301 treatment arm and 229 subjects in Aflibercept treatment arm.	10.0% 23/229 • Number of events 24 • Time Frame Adverse Events (AEs) reported through Week 64 or Early Termination (ET) if occurred before Week 64. One subject randomized to KSI-301 treatment arm received incorrect treatment of Aflibercept, so was included in the Aflibercept treatment arm for safety analyses. Therefore, for adverse event reporting, there are 228 subjects in KSI-301 treatment arm and 229 subjects in Aflibercept treatment arm.

Additional Information

Pablo Velazquez-Martin

Kodiak Sciences Inc

Phone: 1 (650) 281-0850

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place