TerminatedPhase 3

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

Stopped: The primary endpoint was not achieved in the study.

United States998 participantsStarted 2021-03-12

Plain-language summary

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

Who can participate

Age range50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Mean Change in Early Treatment Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letters

Timeframe: Baseline to Week 52

Trial details

NCT IDNCT04757636

SponsorOpthea Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03-31

Results submitted2025-06-24

View on ClinicalTrials.gov More Neovascular Age-related Macular Degeneration trials