OPT-302 With Aflibercept in Neovascular Age-related Macular Degeneration (nAMD)
Phase 3
Terminated
- Conditions
- Neovascular Age-related Macular Degeneration
- Interventions
- Biological: 2.0 mg OPT-302Biological: 2.0 afliberceptProcedure: Sham
- Registration Number
- NCT04757636
- Lead Sponsor
- Opthea Limited
- Brief Summary
A 2-year phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 998
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.
- Additional inclusion/exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2.0 mg aflibercept with Standard Dosing 2.0 mg OPT-302 2.0 mg OPT-302 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. 2.0 mg aflibercept with sham 2.0 aflibercept 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. 2.0 mg aflibercept with sham Sham 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. 2.0 mg aflibercept with Standard Dosing 2.0 mg OPT-302 2.0 aflibercept 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. 2.0 mg aflibercept with Extended Dosing 2.0 mg OPT-302 2.0 mg OPT-302 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. 2.0 mg aflibercept with Extended Dosing 2.0 mg OPT-302 2.0 aflibercept 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.
- Primary Outcome Measures
Name Time Method Mean change in Early Treatment Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters Baseline to Week 52
- Secondary Outcome Measures
Name Time Method Proportion of participants gaining 15 or more ETDRS BCVA letters Baseline to Week 52 Proportion of participants gaining 10 or more ETDRS BCVA letters Baseline to Week 52 Change in choroidal neovascularisation (CNV) area by fluorescein angiography (FA) Baseline to Week 52 Proportion of participants with absence of both sub-retinal fluid and intra-retinal cysts by SD-OCT at Week 52
Trial Locations
- Locations (2)
COAST Investigational Site
🇬🇧London, United Kingdom
COAST Investigational site
🇺🇸Shirley, New York, United States