Trial Outcomes & Findings for The IAI-OCTA Study; a Study of OCT-Angiography Analysis Efficacy (NCT NCT03022292)

Results Overview

Area of the neovascular lesion (in millimeters\^2)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

26 participants

Primary outcome timeframe

Week 24

Results posted on

2022-01-06

Participant Flow

Participant milestones

Participant milestones
Measure	IAI Treatment Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48. Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.
Overall Study STARTED	26
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Measure includes all participants with analyzable baseline BCVA

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IAI Treatment n=26 Participants Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48. Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.
Age, Categorical <=18 years	0 Participants n=26 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=26 Participants
Age, Categorical >=65 years	3 Participants n=26 Participants
Sex: Female, Male Female	6 Participants n=26 Participants
Sex: Female, Male Male	20 Participants n=26 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=26 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=26 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=26 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=26 Participants
Race (NIH/OMB) Asian	0 Participants n=26 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=26 Participants
Race (NIH/OMB) Black or African American	2 Participants n=26 Participants
Race (NIH/OMB) White	19 Participants n=26 Participants
Race (NIH/OMB) More than one race	0 Participants n=26 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=26 Participants
Region of Enrollment United States	26 participants n=26 Participants
Mean BCVA in LogMAR	0.32 score n=25 Participants • Measure includes all participants with analyzable baseline BCVA
OCTA Analysis of Lesion Area	2.008 mm^2 n=26 Participants

PRIMARY outcome

Timeframe: Week 24

Population: Participants present for 24 week assessment

Area of the neovascular lesion (in millimeters\^2)

Outcome measures

Outcome measures
Measure	IAI Treatment n=24 Participants Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48. Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.
Area of Lesion Measured by Optical Coherence Tomography Angiography (OCTA) Scan.	1.07 mm^2 Interval 0.0 to 9.939

PRIMARY outcome

Timeframe: Week 52

Population: Participants present for 52 week assessment

Area of the neovascular lesion (in millimeters\^2)

Outcome measures

Outcome measures
Measure	IAI Treatment n=20 Participants Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48. Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.
Area of Lesion Measured by Optical Coherence Tomography Angiography (OCTA) Scan.	0.67 mm^2 Interval 0.0 to 6.056

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Participants with analyzable ETDRS at both baseline \& week 24

patients with gain of ≥5, ≥10, or ≥15 ETDRS letters. The ETDRS chart is read at 4.0 meters, and presents a series of five letters of equal difficulty on each row, with standardized spacing between letters and rows, for a total of 14 lines (70 letters).

Outcome measures

Outcome measures
Measure	IAI Treatment n=23 Participants Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48. Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.
Best Corrected Visual Acuity (BCVA) -Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Change ≥5 ETDRS letters	4 participants
Best Corrected Visual Acuity (BCVA) -Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Change ≥10 ETDRS letters	2 participants
Best Corrected Visual Acuity (BCVA) -Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Change ≥15 ETDRS letters	0 participants

SECONDARY outcome

Timeframe: Week 24, Week 52

Population: Participants with analyzable BCVA at both 24 and 52 weeks

patients with gain of ≥5, ≥10, or ≥15 ETDRS letters. The ETDRS chart is read at 4.0 meters, and presents a series of five letters of equal difficulty on each row, with standardized spacing between letters and rows, for a total of 14 lines (70 letters).

Outcome measures

Outcome measures
Measure	IAI Treatment n=21 Participants Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48. Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.
Best Corrected Visual Acuity (BCVA) -ETDRS Letter Change ≥5 ETDRS letters	4 participants
Best Corrected Visual Acuity (BCVA) -ETDRS Letter Change ≥10 ETDRS letters	1 participants
Best Corrected Visual Acuity (BCVA) -ETDRS Letter Change ≥15 ETDRS letters	0 participants

SECONDARY outcome

Timeframe: Week 24

Population: Participants with analyzable measure at week 24

Visual acuity (VA) was assessed at a distance of 4 meters from Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.

Outcome measures

Outcome measures
Measure	IAI Treatment n=24 Participants Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48. Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.
Mean Best Corrected Visual Acuity (BCVA)	0.3 score Interval -0.2 to 1.3

SECONDARY outcome

Timeframe: Week 52

Population: Participants with analyzable BCVA at 52 weeks

Visual acuity (VA) was assessed at a distance of 4 meters from Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.

Outcome measures

Outcome measures
Measure	IAI Treatment n=22 Participants Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48. Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.
Mean Best Corrected Visual Acuity (BCVA)	0.33 score Interval -0.2 to 1.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

OCT angiography regression of neovascular membrane as measured by ratio of change in area of the neovascular lesion (in millimeters\^2) during the initial 12 weeks

Outcome measures

Outcome measures
Measure	IAI Treatment n=26 Participants Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48. Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.
OCTA Neovascular Membrane Regression Ratio of Change	0.37 ratio Interval 0.14 to 0.74

OTHER_PRE_SPECIFIED outcome

Timeframe: week 24

Population: Participants present for assessment at week 24

Participants with presence of intraretinal and subretinal fluid, and Subretinal Hyper-Reflective Material (SHRM)

Outcome measures

Outcome measures
Measure	IAI Treatment n=24 Participants Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48. Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.
Presence of Intraretinal and Subretinal Fluid, and Subretinal Hyper-Reflective Material (SHRM) on Spectral Domain Optical Coherence Tomography (SD-OCT) Scan. intraretinal	4 Participants
Presence of Intraretinal and Subretinal Fluid, and Subretinal Hyper-Reflective Material (SHRM) on Spectral Domain Optical Coherence Tomography (SD-OCT) Scan. subretinal	9 Participants
Presence of Intraretinal and Subretinal Fluid, and Subretinal Hyper-Reflective Material (SHRM) on Spectral Domain Optical Coherence Tomography (SD-OCT) Scan. SHRM	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: week 52

Population: Participants present for assessment at 52 weeks

Participants with presence of SD OCT intraretinal and subretinal fluid, and Subretinal Hyper-Reflective Material (SHRM)

Outcome measures

Outcome measures
Measure	IAI Treatment n=22 Participants Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48. Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.
SD OCT Presence of Intraretinal and Subretinal Fluid, and Subretinal Hyper-Reflective Material (SHRM) intraretinal	3 Participants
SD OCT Presence of Intraretinal and Subretinal Fluid, and Subretinal Hyper-Reflective Material (SHRM) subretinal	6 Participants
SD OCT Presence of Intraretinal and Subretinal Fluid, and Subretinal Hyper-Reflective Material (SHRM) SHRM	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 52 weeks

Population: All participants at risk for AE

ocular adverse events

Outcome measures

Outcome measures
Measure	IAI Treatment n=26 Participants Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48. Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.
Ocular AE	2 events

OTHER_PRE_SPECIFIED outcome

Timeframe: 52 weeks

Population: Participants at risk for AE during study

relevant systemic serious adverse events

Outcome measures

Outcome measures
Measure	IAI Treatment n=26 Participants Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48. Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.
Relevant Systemic SAE	1 events

OTHER_PRE_SPECIFIED outcome

Timeframe: week 24

Population: Participants present at week 24 visit

Outcome measures

Outcome measures
Measure	IAI Treatment n=25 Participants Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48. Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.
Number of Injections	25 injections

OTHER_PRE_SPECIFIED outcome

Timeframe: week 52

Population: Participants present for week 52 visit

Outcome measures

Outcome measures
Measure	IAI Treatment n=22 Participants Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48. Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.
Number of Injections	12 injections

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 1-12

Population: Qualitative analyses not performed due to study staff turnover and lack of expertise

In subjects participating in the sub-study of serial OCT Angiography during the initial 12 weeks OCT angiography qualitative analysis of morphological biomarkers of the neovascular complex including attenuation of the fringe during the initial 12 weeks

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to week 24

Population: Participants present for both baseline and week 24 assessment

Ratio of change in SD OCT central macular thickness, calculated as change between visits divided by baseline measure.

Outcome measures

Outcome measures
Measure	IAI Treatment n=24 Participants Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48. Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.
SD OCT Analysis of Central Macular Thickness	0.08 ratio Standard Deviation 0.27

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to week 52

Population: Participants present for both baseline and week 52 assessment

Ratio of change in SD OCT central macular thickness, calculated as change between visits divided by baseline measure.

Outcome measures

Outcome measures
Measure	IAI Treatment n=24 Participants Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48. Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.
SD OCT Analysis of Central Macular Thickness	0.07 ratio Standard Deviation 0.25

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 weeks

Population: Participants present for both baseline and 24 week assessment

OCT angiography ratio of change in neovascular membrane as measured by area of the neovascular lesion in mm\^2 at baseline and week 24. Ratio of change was calculated as change from baseline divided by the baseline value.

Outcome measures

Outcome measures
Measure	IAI Treatment n=24 Participants Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48. Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.
OCTA Analysis of Vessel Density	-0.12 ratio Standard Deviation 2.73

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 1-12

Population: Qualitative analyses not performed due to study staff turnover and lack of expertise

In subjects participating in the sub-study of serial OCT Angiography during the initial 12 weeks) OCT angiography qualitative analysis of morphological biomarkers of the neovascular complex including presence of flow-void areas during the initial 12 weeks

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 1-12

Population: Qualitative analyses not performed due to study staff turnover and lack of expertise

In subjects participating in the sub-study of serial OCT Angiography during the initial 12 weeks) OCT angiography qualitative analysis of morphological biomarkers of the neovascular complex including changes in vessel looping during the initial 12 weeks

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: week 24 and 52

Population: Fluid volume measures not performed due to study staff turnover and lack of expertise

Change in volume of subretinal fluid

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: week 24 and 52

Population: Fluid volume measures not performed due to study staff turnover and lack of expertise

Change volume of SHRM

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: week 24

Population: Participants assessed for CME at week 24

Participants with presence of cystoid macular edema

Outcome measures

Outcome measures
Measure	IAI Treatment n=23 Participants Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48. Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.
Presence of CME (Cystoid Macular Edema) on Spectral Domain Optical Coherence Tomography (SD-OCT) Scan.	4 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: week 52

Population: Participants assessed for CME at week 52

Participants with presence of cystoid macular edema

Outcome measures

Outcome measures
Measure	IAI Treatment n=23 Participants Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48. Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.
Presence of CME (Cystoid Macular Edema) on Spectral Domain Optical Coherence Tomography (SD-OCT) Scan.	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to week 24

Population: Participants present for both baseline and week 24 assessment

Change in ratio of volume of pigment epithelial detachment (PED), calculated as change from baseline divided by baseline value.

Outcome measures

Outcome measures
Measure	IAI Treatment n=24 Participants Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48. Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.
Pigment Epithelial Detachment (PED) Volume as Determined by SD OCT Analysis	0.18 ratio Standard Deviation 0.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Week 52

Population: Participants present for both baseline and week 52 assessment

Change in ratio of volume of PED, calculated as change from baseline divided by baseline value.

Outcome measures

Outcome measures
Measure	IAI Treatment n=24 Participants Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48. Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.
PED Volume as Determined by SD OCT Analysis	0.08 ratio Standard Deviation 0.9

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, week 24

Population: Participants present for both baseline and week 24 assessment

Ratio of change in height of PED, calculated as change from baseline divided by baseline value

Outcome measures

Outcome measures
Measure	IAI Treatment n=24 Participants Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48. Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.
PED Height as Determined by SD OCT Analysis	0.26 ratio Interval 0.03 to 0.51

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, week 52

Population: Participants present for both baseline and week 52 assessment

Ratio of change in height of PED, calculated as change from baseline divided by baseline value

Outcome measures

Outcome measures
Measure	IAI Treatment n=24 Participants Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48. Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.
PED Height as Determined by SD OCT Analysis	0.38 ratio Interval 0.12 to 0.67

Adverse Events

IAI Treatment

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	IAI Treatment n=26 participants at risk Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48. Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.
Eye disorders Retinal detachment	3.8% 1/26 • Number of events 1 • 52 weeks

Other adverse events

Other adverse events
Measure	IAI Treatment n=26 participants at risk Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48. Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	3.8% 1/26 • Number of events 1 • 52 weeks
Infections and infestations Pneumonia	3.8% 1/26 • Number of events 1 • 52 weeks

Additional Information

Dr. David Sarraf

Stein Eye Institute of UCLA

Phone: 310-825-7836

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place