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

Phase 3

Waitlist Available

Research Sponsored by Opthea Limited

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Active subfoveal CNV lesion or juxtafoveal CNV lesion with foveal involvement that is secondary to AMD in the Study Eye.

Clinically significant ocular disorders (other than neovascular AMD), which may interfere with assessment of BCVA, assessment of safety, or fundus imaging.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

Summary

This trial will compare a new treatment to a sham (fake) treatment in order to see if the new treatment is effective. The primary efficacy will be determined at Week 52, meaning that's how long the trial will last.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects were not provided in the information given, but generally, treatments like OPT-302 and Aflibercept may cause eye irritation, discomfort at injection site, changes in vision, increased eye pressure, or inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I have received treatment for wet age-related macular degeneration.

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I'm sorry, but "Main" is not a specific clinical trial exclusion criterion. Could you please provide me with more information or context?

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

0 / 4Eligibility criteria met