Summary

for people ages 50 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion:

Description

Summary

A multicentre, randomised, parallel group, sham-controlled, double-masked, dose-ranging study, investigating two doses of OPT-302 in combination with ranibizumab compared with ranibizumab with sham, over six consecutive monthly dosing cycles in participants with neovascular (wet) AMD.

Official Title

A Dose-Ranging Study of Intravitreal OPT-302 in Combination With Ranibizumab, Compared With Ranibizumab Alone, in Participants With Neovascular Age-Related Macular Degeneration (Wet AMD)

Keywords

Neovascular Age-related Macular Degeneration Macular Degeneration Wet Macular Degeneration Ranibizumab OPT-302 sham intravitreal injection

Eligibility

You can join if…

Open to people ages 50 years and up

  • Active subfoveal choroidal neovascular (CNV) lesion or juxtafoveal lesion secondary to age-related macular AMD
  • An ETDRS BCVA score between 60 and 25 (inclusive) letters

You CAN'T join if...

  • Previous treatment for wet AMD or previous treatment for CNV due to other causes in the Study Eye
  • Clinically significant ocular disorders which may interfere with assessment of visual acuity, assessment of toxicity, or fundus photography in the Study Eye
  • Poorly controlled diabetes mellitus (defined as HbA1c>7%)
  • Any clinically significant cardiovascular, renal or hepatic conditions, recent surgery, or malignancy, that would make the participant unsuitable for the study

Locations

  • Opthea Investigational Site accepting new patients
    San Diego California 94143 United States
  • Opthea Study Site accepting new patients
    Sacramento California 95819 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Opthea Limited
ID
NCT03345082
Phase
Phase 2
Study Type
Interventional
Last Updated