Summary

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

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, Macular Degeneration, Wet Macular Degeneration, Ranibizumab, 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 California 95817 United States
  • ShORe Investigational Site
    Sacramento California 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