Summary

Eligibility
for people ages 50 years and up (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
estimated 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.

Locations

  • ShORe Investigational Site accepting new patients
    Sacramento California 95817 United States
  • ShORe Investigational Site accepting new patients
    Sacramento California 95825 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Opthea Limited
Links
Check your eligibility for this study and nearest site location Sign up for this study
ID
NCT04757610
Phase
Phase 3 Macular Degeneration Research Study
Study Type
Interventional
Participants
Expecting 990 study participants
Last Updated