OPT-302 + Aflibercept for Age-Related Macular Degeneration
(COAST Trial)

Recruiting in Palo Alto (17 mi)

+203 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 individuals with neovascular Age-related Macular Degeneration (nAMD) who have a specific level of vision acuity, measured by the ETDRS BCVA score between 60 and 25. Participants can have had previous treatments for nAMD but must not have other significant eye disorders or any conditions that could affect study participation.

Inclusion Criteria

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

You have a medical, psychological, or social condition that makes it impossible for you to participate in the study.

I do not have serious eye problems that could affect vision tests or safety assessments.

+3 more

Participant Groups

The study is testing a new treatment called OPT-302 in combination with Aflibercept against a sham procedure over two years. The main goal is to see how well it works after one year. Patients are randomly assigned to either get the real treatments or a pretend one without knowing which they're getting.

3Treatment groups

Experimental Treatment

Placebo Group

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

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

2.0 mg aflibercept intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-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: 2.0 mg aflibercept with shamPlacebo Group2 Interventions

2.0 mg aflibercept intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-weekly intervals. Sham intravitreal injection administered at 4-weekly intervals.

Aflibercept is already approved in United States, European Union, United States for the following indications:

🇺🇸 Approved in United States as Eylea for: