OPT-302 + Ranibizumab for Age-Related Macular Degeneration

(ShORe Trial)

No longer 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

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 new treatments for age-related macular degeneration (AMD), a condition that can cause vision loss. The researchers aim to evaluate the effectiveness of combining OPT-302 (an experimental treatment) with Ranibizumab, compared to Ranibizumab alone. Participants will receive injections in the eye at regular intervals. Individuals with AMD, specific types of lesions, and moderate vision loss might be suitable for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.

Do I need to stop taking my current medications for this 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 has shown that using OPT-302 with ranibizumab is generally safe. In one study, patients received different doses of OPT-302 with ranibizumab, and they tolerated the treatment well. Most side effects were mild and similar to those seen with ranibizumab alone.

Ranibizumab has been used for some time to treat age-related macular degeneration (AMD). Studies have shown it is safe and effective for long-term use in maintaining vision.

For both OPT-302 and ranibizumab, the most common side effects included mild eye issues like redness or discomfort. Serious side effects were rare. Overall, trials have demonstrated a good safety profile for this combination, making it a viable option for patients considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for age-related macular degeneration because they offer a fresh approach to tackling the condition. Unlike traditional treatments that mainly use anti-VEGF drugs like ranibizumab alone, the addition of OPT-302 introduces a new mechanism by inhibiting both VEGF-C and VEGF-D, potentially enhancing the effectiveness of the treatment. This dual-action approach might provide better outcomes by addressing more pathways involved in macular degeneration. Additionally, the extended dosing schedule of OPT-302 could mean fewer injections for patients, making the treatment more convenient.

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

Research has shown that using OPT-302 with ranibizumab may help treat age-related macular degeneration (AMD). In this trial, participants will receive either a combination of OPT-302 and ranibizumab or ranibizumab with a sham treatment. Earlier trials demonstrated that patients receiving both treatments experienced better vision improvements than those receiving only ranibizumab. OPT-302 blocks certain proteins that cause harmful blood vessel growth in the eye, a key issue in AMD. Specifically, one study found that patients receiving both OPT-302 and ranibizumab saw significant improvements in visual clarity. These results suggest that this combination could effectively manage AMD. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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.

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 ranibizumab and OPT-302 at specified intervals

52 weeks

4-weekly visits for injections

Follow-up

Participants are monitored for safety and effectiveness after treatment

52 weeks

What Are the Treatments Tested in This Trial?

Interventions

• OPT-302
• Ranibizumab
• Sham

Trial Overview 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.

How Is the Trial Designed?

Group I: 0.5 mg ranibizumab with Standard Dosing 2.0 mg OPT-302 Experimental Treatment 2 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-302 Experimental Treatment 2 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 sham Placebo Group 2 Interventions

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

Who Is Running the Clinical Trial?

Opthea Limited

Lead Sponsor

Trials

5

Recruited

2,600+

Citations

1. 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.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04757610

NCT04757610 | OPT-302 With Ranibizumab in ... A 2-year, phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.

3. ir.opthea.com ir.opthea.com/news-releases/news-release-details/opthea-phase-2b-trial-results-opt-302-combination-lucentisr-wet

Opthea Phase 2b Trial Results of OPT-302 in Combination ... Opthea Phase 2b Trial Results of OPT-302 in Combination with Lucentis® for wet AMD Published in the Journal Ophthalmology · Stay Informed.

4. 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.

5. trialx.com trialx.com/clinical-trials/listings/252189/opt-302-with-ranibizumab-in-neovascular-age-related-macular-degeneration-namd/

OPT-302 With Ranibizumab in Neovascular Age-related ... Primary efficacy will be determined at Week 52. Eligibility. Inclusion Criteria: Active subfoveal CNV lesion or juxtafoveal CNV lesion with ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0161642023000660

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 inhibitor of VEGF-C and D, in combination with the anti–VEGF-A inhibitor ranibizumab.

7. ir.opthea.com ir.opthea.com/news-releases/news-release-details/opthea-presents-positive-phase-2b-data-euretina-congress

Opthea Presents Positive Data from OPT-302 Phase 2b ... OPT-302 combination therapy also reduced total lesion area and choroidal neovascularisation (CNV) area compared to ranibizumab alone. “We are ...