OPT-302 With Aflibercept in Neovascular Age-related Macular Degeneration (nAMD)

Study Overview
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Brief Summary
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A 2-year phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.

Official Title
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A Phase 3, Multicentre, Double-masked, Randomised Study to Evaluate the Efficacy and Safety of Intravitreal OPT-302 in Combination With Aflibercept, Compared With Aflibercept Alone, in Participants With nAMD

Conditions
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Neovascular Age-related Macular Degeneration

Intervention / Treatment
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* Biological: 2.0 mg OPT-302
* Biological: 2.0 aflibercept
* Procedure: Sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Active subfoveal CNV lesion or juxtafoveal CNV lesion with foveal involvement that is secondary to AMD in the Study Eye. An ETDRS BCVA score between 60 and 25 (inclusive) letters in the Study Eye. Main Exclusion Criteria: Any previous treatment for neovascular AMD. Clinically significant ocular disorders (other than neovascular AMD), which may interfere with assessment of BCVA, assessment of safety, or fundus imaging. Any current (or history of a) social, psychological, or medical condition that precludes enrolment into the study.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2.0 mg aflibercept with Standard Dosing 2.0 mg OPT-302<br>2.0 mg aflibercept intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-weekly intervals. 2.0 mg OPT-302 intravitreal injection administered at 4-weekly intervals. | Biological: 2.0 mg OPT-302<br>* intravitreal injection<br>Biological: 2.0 aflibercept<br>* intravitreal injection<br>|
| Experimental: 2.0 mg aflibercept with Extended Dosing 2.0 mg OPT-302<br>2.0 mg aflibercept intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-weekly intervals. 2.0 mg OPT-302 intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-weekly intervals, with sham intravitreal injection administered at visits when OPT-302 is not. | Biological: 2.0 mg OPT-302<br>* intravitreal injection<br>Biological: 2.0 aflibercept<br>* intravitreal injection<br>|
| Sham Comparator: 2.0 mg aflibercept with sham<br>2.0 mg aflibercept intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-weekly intervals. Sham intravitreal injection administered at 4-weekly intervals. | Biological: 2.0 aflibercept<br>* intravitreal injection<br>Procedure: Sham<br>* intravitreal injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in Early Treatment Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters |  | Baseline to Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants gaining 10 or more Early Treatment Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters |  | Baseline to Week 52 | 
| Proportion of participants gaining 15 or more Early Treatment Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters |  | Baseline to Week 52 | 
| Proportion of participants with absence of both sub-retinal fluid (SRF) and intra-retinal (IR) cysts by spectral domain optical coherence tomography (SD-OCT) |  | at Week 52 | 
| Change in choroidal neovascularisation (CNV) area by fluorescein angiography (FA) |  | Baseline to Week 52 | 
| Change in central subfield thickness (CST) by spectral domain optical coherence tomography (SD-OCT) |  | Baseline to Week 52 | 
| Change in National Eye Institute 25-question visual function questionnaire (NEI VFQ-25) composite score | Change in mean composite score of 25 questions. A higher mean change means an overall improvement in visual function. | Baseline to Week 52 |