OPT-302 + Aflibercept for Age-Related Macular Degeneration

(COAST Trial)

Recruiting at 208 trial locations

Overseen By Opthea Limited

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Opthea Limited

Disqualifiers: Previous AMD treatment, Ocular disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 4

Duration: 52 weeks

998 Participants Needed

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravitreal injections of aflibercept and OPT-302 or sham at specified intervals

52 weeks

4-weekly intervals for three treatments, then 8-weekly intervals

Follow-up

Participants are monitored for safety and effectiveness after treatment

52 weeks

Treatment Details

Interventions

• Aflibercept
• OPT-302
• Sham

Trial Overview 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.

Participant Groups

Group I: 2.0 mg aflibercept with Standard Dosing 2.0 mg OPT-302 Experimental Treatment 2 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.

Group II: 2.0 mg aflibercept with Extended Dosing 2.0 mg OPT-302 Experimental Treatment 2 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 sham Placebo Group 2 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 for the following indications:

Approved in United States as Eylea for:

• Neovascular (Wet) Age-Related Macular Degeneration (AMD)
• Macular Edema following Retinal Vein Occlusion (RVO)
• Diabetic Macular Edema (DME)
• Diabetic Retinopathy (DR)

Approved in European Union as Eylea for:

• Neovascular (Wet) Age-Related Macular Degeneration (AMD)
• Macular Edema following Retinal Vein Occlusion (RVO)
• Diabetic Macular Edema (DME)
• Diabetic Retinopathy (DR)

Approved in United States as Zaltrap for:

• Metastatic Colorectal Cancer

Who Is Running the Clinical Trial?

Opthea Limited

Lead Sponsor

Trials

5

Recruited

2,600+