OPT-302 + Ranibizumab for Age-Related Macular Degeneration
(ShORe Trial)

Recruiting in Palo Alto (17 mi)

+188 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Opthea Limited

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?A 2-year, phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.

Eligibility Criteria

This trial is for adults with active neovascular Age-related Macular Degeneration (nAMD) affecting the central part of their vision. Participants must have a certain level of visual acuity, measured by ETDRS BCVA score between 60 and 25 letters. Those with other significant eye disorders or conditions that could affect study participation or results are not eligible.

Inclusion Criteria

My eye condition is due to AMD and affects the center of my vision.

I have been treated for wet age-related macular degeneration before.

You have a BCVA of 60 to 25 letters in the Study Eye.

+3 more

Participant Groups

The study is testing the effectiveness of a new treatment called OPT-302 in combination with ranibizumab compared to ranibizumab alone, over two years. Patients will be randomly assigned to receive either both drugs or one drug plus a sham procedure, without knowing which group they're in.

3Treatment groups

Experimental Treatment

Placebo Group

Group I: 0.5 mg ranibizumab with Standard Dosing 2.0 mg OPT-302Experimental Treatment2 Interventions

0.5 mg ranibizumab intravitreal injection administered at 4-weekly intervals. 2.0 mg OPT-302 intravitreal injection administered at 4-weekly intervals.

Group II: 0.5 mg ranibizumab with Extended Dosing 2.0 mg OPT-302Experimental Treatment2 Interventions

0.5 mg ranibizumab intravitreal injection administered at 4-weekly intervals. 2.0 mg OPT-302 intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-weekly intervals, with sham intravitreal injection administered at visits when OPT-302 is not.

Group III: 0.5 mg ranibizumab with shamPlacebo Group2 Interventions

0.5 mg ranibizumab intravitreal injection administered at 4-weekly intervals. Sham intravitreal injection administered at 4-weekly intervals.