OPT-302 + Aflibercept for Age-Related Macular Degeneration

(COAST Trial)

No longer recruiting at 229 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of treatments for age-related macular degeneration (AMD), a common eye condition that can lead to vision loss. Researchers aim to determine if adding OPT-302, an experimental treatment, to the standard aflibercept treatment improves vision outcomes over a year. The study will explore different dosing schedules to identify the best approach. Individuals with AMD affecting the center of their vision who have not received prior treatment might be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that combining OPT-302 and aflibercept is generally safe for patients. Earlier studies on this treatment for wet age-related macular degeneration (a vision condition) showed similar safety results, with most patients experiencing no serious side effects.

In the trials, a few patients reported mild side effects like eye discomfort, but these were uncommon. Serious side effects were rare. Overall, evidence suggests that the treatment is safe for people. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for age-related macular degeneration (AMD), which primarily focus on inhibiting a protein called VEGF, the OPT-302 treatment targets another protein in the same family called VEGF-C/D. This dual-action approach, using OPT-302 alongside the traditional VEGF inhibitor aflibercept, aims to provide a more comprehensive blockade of the pathways that drive the disease. Researchers are excited because this could potentially lead to better outcomes for patients by addressing multiple factors that contribute to vision loss in AMD.

What evidence suggests that this trial's treatments could be effective for age-related macular degeneration?

Research shows that using OPT-302 with aflibercept may improve vision in people with age-related macular degeneration (AMD). In this trial, some participants will receive the combination of OPT-302 and aflibercept, which, in one study, led to an average improvement of 13.5 letters on a vision chart. OPT-302 blocks certain proteins that can cause the growth of new, leaky blood vessels, potentially damaging vision. Earlier trials found no major side effects from this combination, suggesting it is safe to use. This therapy is under study because it might be more effective than using aflibercept alone, which is another treatment arm in this trial. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. ir.opthea.com ir.opthea.com/static-files/fd4f9bb5-c99f-44e4-b939-a4b8f6708835

Switching to combination OPT-302 with aflibercept from ... Intravitreal OPT-302 combination therapy may improve outcomes in DME ... • No study drug related adverse events. • OPT-302 + Aflibercept showed a dose ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04757636

Study Details | NCT04757636 | OPT-302 With Aflibercept in ... A Phase 3, Multicentre, Double-masked, Randomised Study to Evaluate the Efficacy and Safety of Intravitreal OPT-302 in Combination With Aflibercept, ...

3. firstwordpharma.com firstwordpharma.com/story/5944104

Future in doubt as Opthea's AMD drug flunks first pivotal ... Meanwhile, in the overall study population, the combination therapy administered every four weeks yielded a 13.5-letter improvement, while the ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36754174/

A Randomized Controlled Trial of OPT-302, a VEGF-C/D ... This trial aimed to test the safety and efficacy of OPT-302, a biologic ... age-related macular degeneration; OPT-302; Randomized controlled trial.

5. touchophthalmology.com touchophthalmology.com/macular-degeneration/journal-articles/sozinibercept-is-the-tide-turning-for-better-visual-outcomes-in-neovascular-age-related-macular-degeneration/

Sozinibercept: Is the Tide Turning for Better Visual ... The phase II trial results for sozinibercept had positive data showing increased vision with novel VEGF-C and D inhibition in combination with ranibizumab.

6. aaojournal.org aaojournal.org/article/S0161-6420(23)00066-0/fulltext

A Randomized Controlled Trial of OPT-302, a VEGF-C/D ... A randomized controlled trial of OPT-302, a VEGF-C/D inhibitor for neovascular age-related macular degeneration.

7. clinicaltrials.eu clinicaltrials.eu/trial/study-of-opt-302-and-aflibercept-for-patients-with-wet-age-related-macular-degeneration/

Study of OPT-302 and Aflibercept for Patients with Wet Age ... This clinical trial investigates the efficacy and safety of the combination of OPT-302 and Aflibercept in treating wet age-related macular degeneration, ...