OPT-302 With Aflibercept in Neovascular Age-related Macular Degeneration (nAMD) (COAST)
Neovascular Age-related Macular Degeneration
About this trial
This is an interventional treatment trial for Neovascular Age-related Macular Degeneration
Eligibility Criteria
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.
Sites / Locations
- COAST Investigational SiteRecruiting
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Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Sham Comparator
2.0 mg aflibercept with Standard Dosing 2.0 mg OPT-302
2.0 mg aflibercept with Extended Dosing 2.0 mg OPT-302
2.0 mg aflibercept with sham
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 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 intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-weekly intervals. Sham intravitreal injection administered at 4-weekly intervals.