Summary

Eligibility
for people ages 50 years and up (full criteria)
Location
at Los Angeles 5368361, California 5332921 and other locations
Dates
study started
study ends

Description

Summary

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

Official Title

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

Keywords

Neovascular Age-related Macular Degeneration, Ranibizumab, salicylhydroxamic acid, 2.0 mg OPT-302, 0.5 mg ranibizumab

Eligibility

You can join if…

Open to people ages 50 years and up

  • 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.

You CAN'T join if...

  • 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 may apply

Locations

  • ShORe Investigational Site
    Los Angeles 5368361 California 5332921 95817 United States
  • ShORe Investigational Site
    Sacramento 5389489 California 5332921 95817 United States

Details

Status
accepting new patients
Start Date
Completion Date
Sponsor
Opthea Limited
Links
Sign up for this study
ID
NCT04757610
Phase
Phase 3 Macular Degeneration Research Study
Study Type
Interventional
Participants
About 986 people participating
Last Updated