OPT-302 + Ranibizumab for Age-Related Macular Degeneration

(ShORe Trial)

Recruiting at 188 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

986 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 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

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

Treatment Details

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.

Participant Groups

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+