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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 38 to 93 days after implantation
Awards & highlights
Belvedere 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.Check my eligibility
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.See study design
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.
Belvedere Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Select...
My eye condition affects the center of my retina.
Select...
I have scarring or tissue loss in the center of my retina.
Select...
I've had 3 or more anti-VEGF injections for nAMD, not including ranibizumab, in the last 9 months.
Select...
I have been treated with a drug similar to anti-VEGF before.
Select...
I have or had swelling in the cornea of my eye.
Select...
I have nerve damage in my eye.
Select...
My eye's cornea has fewer than 1500 cells per mm2.
Select...
My blood pressure is not well-managed.
Select...
I have had surgery for glaucoma.
Select...
I have or had pseudoexfoliation syndrome.
Select...
I have or had a corneal dystrophy.
Select...
I have severe nearsightedness of more than 8 diopters or a diagnosis of pathologic myopia.
Select...
My eye condition is at least moderate in severity.
Select...
I have an eye condition in the upper outer part of my eye.
Select...
I have uncontrolled high eye pressure or glaucoma.
Select...
I have had damage to the inner layer of my eye from injury or surgery.
Select...
I have had eye surgery to remove the vitreous gel.
Select...
My eyesight was more than 8 diopters nearsighted before my eye surgery.
Select...
I have a significant bleed in the center of my retina.
Select...
I have had a corneal transplant.
Select...
I have a history of severe eye inflammation or dryness.
Select...
My eyelashes grow inward towards my eye.
Select...
I have been treated with brolucizumab before.
Select...
I have or had an autoimmune disease like rheumatoid arthritis or lupus.
Select...
I have an eye condition that prevents clear imaging tests.
Select...
My eyelid condition affects its ability to protect my eye.
Select...
I don't have eye conditions needing surgery that could affect the study.
Select...
My last 2 treatments for eye disease were with bevacizumab or aflibercept.
Select...
I have or had facial nerve weakness.
Select...
I have not used any anti-VEGF medications.
Select...
I have a condition affecting the white part of my eye, specifically in the upper outer area.
Select...
I have had eye surgery for AMD.
Select...
I am currently fighting an infection in my body.
Select...
My other eye lacks a lens or has a missing back part.
Select...
My AMD affects the central part of my retina.
Select...
I have complete records of my anti-VEGF treatments for nAMD.
Select...
My eyes meet the study's health requirements.
Select...
My eyesight was more than +5 before my eye surgery.
Select...
I haven't taken cancer drugs that stop cell division or affect metabolism in the last 30 days.
Select...
I have records of my eye health before starting anti-VEGF treatment for nAMD.
Select...
I do not have a natural lens in my eye or part of it is missing.
Select...
I was diagnosed with wet age-related macular degeneration between 6 and 18 months ago.
Select...
I have had a positive response to eye injections for my condition and can see the big E on the eye chart.
Select...
I have had radiation treatment before.
Belvedere Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 38 to 93 days after implantation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~38 to 93 days after implantation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent change in corneal ECD from baseline at Week 48 in the study eye as compared with the fellow eye, as assessed by specular microscopy
Secondary outcome measures
Percent change in HEX from baseline at Weeks 24 and 48 in the study eye as compared with the fellow eye
Percent change in corneal ECD from baseline at Week 24 in the study eye as compared with the fellow eye
Percent change in the CV of corneal endothelial cell area (standard deviation of the cell area/mean cell area) from baseline at Weeks 24 and 48 in the study eye as compared with the fellow eye
+6 moreBelvedere Trial Design
1Treatment groups
Experimental Treatment
Group I: SUSVIMOExperimental Treatment2 Interventions
Participants will have the implant (filled prior to implantation with approximately 20 uL of the 100-mg/mL formulation of ranibizumab [approximately 2-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, patients will receive implant refill-exchanges at fixed 24-week intervals.
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Who is running the clinical trial?
Genentech, Inc.Lead Sponsor
1,539 Previous Clinical Trials
567,504 Total Patients Enrolled
Clinical TrialsStudy DirectorGenetech
2,199 Previous Clinical Trials
888,317 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a heart attack in the last 3 months.I have a tear in the layer of my eye's retina.I have had an eye injury before.I have or had a rare eye condition affecting the cornea and iris.I have had eye surgery in the upper outer part of my eye.I have had bleeding in the gel-like substance inside my eye.My eye condition affects the center of my retina.I have scarring or tissue loss in the center of my retina.I've had 3 or more anti-VEGF injections for nAMD, not including ranibizumab, in the last 9 months.I have been treated with a drug similar to anti-VEGF before.I have or had swelling in the cornea of my eye.I have nerve damage in my eye.I have had laser treatment for age-related macular degeneration.I have had a retinal detachment due to a tear or break.My eye's cornea has fewer than 1500 cells per mm2.I don't have any health conditions that would make using ranibizumab or getting an implant risky.My blood pressure is not well-managed.I have had surgery for glaucoma.I have had irregular heartbeats that were not controlled in the last 3 months.I have or had pseudoexfoliation syndrome.I have or had a corneal dystrophy.I have previously received verteporfin, radiation therapy, or thermotherapy for my eyes.I have severe nearsightedness of more than 8 diopters or a diagnosis of pathologic myopia.My eye condition is at least moderate in severity.You have worn contact lenses in either eye within the last two months.I have not had a stroke in the last 3 months.I have been treated with ranibizumab before.I have an eye condition in the upper outer part of my eye.I have uncontrolled high eye pressure or glaucoma.I have had damage to the inner layer of my eye from injury or surgery.I have had eye surgery to remove the vitreous gel.You have difficulty completely closing your eyelids or blinking.My eyesight was more than 8 diopters nearsighted before my eye surgery.I have a significant bleed in the center of my retina.I have had a corneal transplant.I have a history of severe eye inflammation or dryness.My eyelashes grow inward towards my eye.You have had a PDS (a type of implantable medical device) implanted in the past.I have not had specific eye laser treatments in the last year.I have been treated with brolucizumab before.I have or had an autoimmune disease like rheumatoid arthritis or lupus.I have an eye condition that prevents clear imaging tests.I regularly take oral corticosteroids.My eyelid condition affects its ability to protect my eye.I have had a corticosteroid injection in my eye before.You have had a device implanted inside your eye (excluding lenses).I don't have eye conditions needing surgery that could affect the study.My last 2 treatments for eye disease were with bevacizumab or aflibercept.I have or had facial nerve weakness.I have not used any anti-VEGF medications.I have a condition affecting the white part of my eye, specifically in the upper outer area.I have had eye surgery for AMD.I am currently fighting an infection in my body.My other eye lacks a lens or has a missing back part.I have not had eye surgery in the last 6 months.You have participated in a clinical trial that involved a specific type of medication injected into the eye called anti-VEGF agents.My AMD affects the central part of my retina.I have complete records of my anti-VEGF treatments for nAMD.I have had a corneal transplant.My eyes meet the study's health requirements.My eyesight was more than +5 before my eye surgery.I haven't taken cancer drugs that stop cell division or affect metabolism in the last 30 days.I have records of my eye health before starting anti-VEGF treatment for nAMD.Your eyes are clear enough and your pupils can dilate properly to allow for a thorough eye examination and analysis of images.I have had recent treatment for retinal tears or breaks.I do not have a natural lens in my eye or part of it is missing.I haven't had active cancer in the last year, except for certain treated cancers.I was diagnosed with wet age-related macular degeneration between 6 and 18 months ago.I have had a positive response to eye injections for my condition and can see the big E on the eye chart.I have had radiation treatment before.I have not had a previous issue with the back of my eye lens unless it was treated with a specific laser after lens implant surgery.
Research Study Groups:
This trial has the following groups:- Group 1: SUSVIMO
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Age-Related Macular Degeneration Patient Testimony for trial: Trial Name: NCT04853251 — Phase 4
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
For what ailments is Port Delivery System with Ranibizumab normally prescribed?
"Branch vein occlusion, wet age-related macular degeneration (wAMD), and macular edema can all be addressed with the Port Delivery System that features Ranibizumab."
Answered by AI
Are there any available slots yet for the participants of this clinical trial?
"As per clinicaltrials.gov, this experiment is still welcoming participants. It was originally published on December 14th 2021 and revised in November 18th 2022."
Answered by AI
How many individuals are engaged in this experimentation?
"This trial seeks 200 qualified individuals with matching inclusion criteria to participate. Participants may register at Northern California Retina Vitreous Associates in Mountain View, California or Tufts Medical Center in Boston, Massachusetts."
Answered by AI
What prior investigations have explored the efficacy of utilizing Port Delivery System in conjunction with Ranibizumab?
"The Port Delivery System with Ranibizumab was first researched in 2008 at the Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery. Since then, 311 trials have been finished while 31 are still ongoing; notably, Mountain View is a major hub of activity for this drug."
Answered by AI
In which geographical areas is this trial currently taking place?
"Currently, study participants can be recruited from Northern California Retina Vitreous Associates in Mountain View, Tufts Medical Center in Boston, and California Retina Consultants in Bakersfield; there are an additional 40 trial sites."
Answered by AI
What potential hazards come with using the Port Delivery System and Ranibizumab?
"The safety of Port Delivery System with Ranibizumab is highly rated by Power, achieving a score of 3. This evaluation was based on the fact that Port Delivery System has already been approved for use in clinical trials."
Answered by AI
Who else is applying?
What state do they live in?
Florida
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
i dish to preserve existing vision.
PatientReceived no prior treatments
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