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Angiogenesis Inhibitor

OPT-302 + Ranibizumab for Age-Related Macular Degeneration (ShORe 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.

Any previous treatment for neovascular AMD.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

Summary

This trial will compare the efficacy of a new treatment to a sham treatment over the course of 52 weeks.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects may include typical reactions related to eye injections such as eye pain, bleeding, inflammation, increased intraocular pressure, and potential impact on vision. The specific side effects of OPT-302 are not detailed but would be monitored closely.

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 have been treated for wet age-related macular degeneration before.

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

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I'm sorry, but "Main" is not a clear or specific criterion. Could you please provide more context or information for me to accurately summarize it in plain language?

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: 0.5 mg ranibizumab with Standard Dosing 2.0 mg OPT-302Experimental Treatment2 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-302Experimental Treatment2 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 shamPlacebo Group2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

0.5 mg ranibizumab

2012

Completed Phase 3

~260

0 / 4Eligibility criteria met