Status:
TERMINATED
OPT-302 With Aflibercept in Neovascular Age-related Macular Degeneration (nAMD)
Lead Sponsor:
Opthea Limited
Conditions:
Neovascular Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
A 2-year phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2025
Estimated Enrollment :
998 Patients enrolled
Trial Details
Trial ID
NCT04757636
Start Date
March 12 2021
End Date
March 31 2025
Last Update
August 5 2025
Active Locations (209)
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1
COAST Investigational Site
Phoenix, Arizona, United States, 85053
2
COAST Investigational Site
Arcadia, California, United States, 91006
3
COAST Investigational Site
Huntington Beach, California, United States, 92647
4
COAST Investigational Site
Redlands, California, United States, 92374