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Monoclonal Antibodies

SUSVIMO for Age-Related Macular Degeneration (Belvedere Trial)

Phase 4

Recruiting

Research Sponsored by Genentech, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Retinal pigment epithelial tear

Any prior ocular trauma (blunt or penetrating)

Must not have

History of conjunctival surgery in the superotemporal quadrant

History of vitreous hemorrhage

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 52

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will assess the response to treatment with SUSVIMO given every 24 weeks in patients with nAMD who have been previously treated with anti-VEGF agents. A substudy will evaluate the impact of SUSVIMO on corneal endothelial cells.

Who is the study for?

This trial is for patients with neovascular age-related macular degeneration (nAMD) who have been treated with anti-VEGF agents other than ranibizumab. They must have a history of responding to these treatments, clear ocular media, and no severe eye conditions or recent strokes. Pregnant women and those planning pregnancy are excluded.

What is being tested?

The study tests the response to SUSVIMO (ranibizumab injection), refilled every 24 weeks in nAMD patients previously treated with different anti-VEGFs. It's an open-label Phase IV trial assessing treatment efficacy and impact on corneal endothelial cells.

What are the potential side effects?

Potential side effects may include eye irritation, increased intraocular pressure, inflammation inside the eye, bleeding or pain at the injection site, vision changes, floaters, and possible infection risk due to intravitreal injections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a tear in the layer of my eye's retina.

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I have had an eye injury before.

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I have or had a rare eye condition affecting the cornea and iris.

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I have scarring or tissue loss in the center of my retina.

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I have been treated with a drug similar to anti-VEGF before.

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I have or had swelling in the cornea of my eye.

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I have nerve damage in my eye.

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My eye's cornea has fewer than 1500 cells per mm2.

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My blood pressure is not well-managed.

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I have had surgery for glaucoma.

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I have or had pseudoexfoliation syndrome.

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I have or had a corneal dystrophy.

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I have severe nearsightedness of more than 8 diopters or a diagnosis of pathologic myopia.

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My eye condition is at least moderate in severity.

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I have an eye condition in the upper outer part of my eye.

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I have uncontrolled high eye pressure or glaucoma.

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I have had damage to the inner layer of my eye from injury or surgery.

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I have had eye surgery to remove the vitreous gel.

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My eyesight was more than 8 diopters nearsighted before my eye surgery.

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I have a significant bleed in the center of my retina.

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I have had a corneal transplant.

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I have a history of severe eye inflammation or dryness.

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My eyelashes grow inward towards my eye.

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I have been treated with brolucizumab before.

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I have or had an autoimmune disease like rheumatoid arthritis or lupus.

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I have an eye condition that prevents clear imaging tests.

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My eyelid condition affects its ability to protect my eye.

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I don't have eye conditions needing surgery that could affect the study.

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My last 2 treatments for eye disease were with bevacizumab or aflibercept.

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I have or had facial nerve weakness.

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I have not used any anti-VEGF medications.

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I have a condition affecting the white part of my eye, specifically in the upper outer area.

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I have had eye surgery for AMD.

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I am currently fighting an infection in my body.

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My other eye lacks a lens or has a missing back part.

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My AMD affects the central part of my retina.

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My eyesight was more than +5 before my eye surgery.

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I haven't taken cancer drugs that stop cell division or affect metabolism in the last 30 days.

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I do not have a natural lens in my eye or part of it is missing.

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I have had a positive response to eye injections for my condition and can see the big E on the eye chart.

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I have had radiation treatment before.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had eye surgery in the upper outer part of my eye.

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I have had bleeding in the gel-like substance inside my eye.

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I have had laser treatment for age-related macular degeneration.

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I have had a retinal detachment due to a tear or break.

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I have previously received verteporfin, radiation therapy, or thermotherapy for my eyes.

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I have been treated with ranibizumab before.

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I have had a corticosteroid injection in my eye before.

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I have had a corneal transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Percentage of Participants With Ocular AESIs During the Follow-up Period

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: SUSVIMOExperimental Treatment2 Interventions

Participants will have the implant (filled prior to implantation with approximately 20 microlitres (uL) of the 100 milligrams/millilitres (mg/ml) formulation of ranibizumab \[approximately 2 milligrams (mg) dose of ranibizumab\]) surgically inserted in the study eye at the Day 1 visit following their enrollment visit. After the initial fill of the implant with ranibizumab, participants will receive implant refill-exchanges at fixed Q24W intervals.

0 / 49Eligibility criteria met