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Anti-VEGF Monoclonal Antibody
Zifibancimig for Age-Related Macular Degeneration (BURGUNDY Trial)
Phase 1
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Choroidal neovascularization (CNV) exclusively due to age-related macular degeneration (AMD)
Decreased best corrected visual acuity (BCVA) attributable primarily to neovascular AMD (nAMD), with BCVA letter score of 78 to 34 letters (inclusive) on early treatment diabetic retinopathy study (ETDRS)-like charts at screening. In case both eyes of a participant are eligible, the eye with the lower BCVA score should become the study eye.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up part 1: baseline up to week 24; part 2: baseline up to week 144; part 3: baseline up to week 144
Awards & highlights
BURGUNDY Trial Summary
This trial is testing a new drug for age-related macular degeneration given through injections in the eye and via a delivery system. They are testing how safe and effective it is.
Who is the study for?
Adults with neovascular age-related macular degeneration (nAMD) who have had previous treatments with specific eye injections. They must have a certain level of vision clarity and be willing to undergo additional procedures for the study. People with recent cancer, certain eye surgeries, or conditions that could affect the trial's outcome are excluded.Check my eligibility
What is being tested?
The safety and effectiveness of Zifibancimig for nAMD is being tested. It's given as an injection into the eye or through a special implant called Port Delivery Platform. The study compares this new treatment to Ranibizumab, an existing medication.See study design
What are the potential side effects?
Possible side effects include irritation at the injection site, inflammation inside the eye, blurred vision, bleeding in the retina, and potential infection risks associated with intravitreal procedures.
BURGUNDY Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have CNV due to AMD.
Select...
My vision loss is mainly due to wet AMD, with specific vision test scores.
Select...
My vision loss is solely due to age-related macular degeneration.
Select...
My vision loss is mainly due to wet AMD, scoring 34-73 on a vision chart.
Select...
I've responded to previous eye injections for my condition.
Select...
My vision loss is mainly due to wet AMD, and my vision score is between 78 to 34.
Select...
I have CNV due to AMD.
Select...
My vision loss is solely due to age-related macular degeneration.
BURGUNDY Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ part 1: baseline up to week 24; part 2: baseline up to week 144; part 3: baseline up to week 144
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~part 1: baseline up to week 24; part 2: baseline up to week 144; part 3: baseline up to week 144
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline in Early Treatment Diabetic Retinopathy Study - Best Corrected Visual Acuity (ETDRS-BCVA) Score
Duration of ADEs
Duration of AESIs including Ocular AESIs
+8 moreSecondary outcome measures
Area Under the Curve (AUC) of Zifibancimig in Blood and AH
Change from Baseline Over Time in CST
Change from Baseline in Central Subfield Thickness (CST)
+5 moreBURGUNDY Trial Design
6Treatment groups
Experimental Treatment
Active Control
Group I: Part 3: Port Delivery with Low DoseExperimental Treatment2 Interventions
Zifibancimig administered at a low dose through the PD implant.
Group II: Part 3: Port Delivery with High DoseExperimental Treatment2 Interventions
Zifibancimig administered at a high dose through the PD implant.
Group III: Part 2: Port Delivery with Low DoseExperimental Treatment2 Interventions
Zifibancimig administered at a low dose through the PD implant.
Group IV: Part 2: Port Delivery with High DoseExperimental Treatment2 Interventions
Zifibancimig administered at a high dose through the PD implant.
Group V: Part 1: Intravitreal InjectionsExperimental Treatment1 Intervention
Zifibancimig administered in ascending dose levels through IVT injections.
Group VI: Part 3: Port Delivery with RanibizumabActive Control2 Interventions
100 milligrams/milliliter (mg/mL) of ranibizumab administered through the PD implant.
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,432 Previous Clinical Trials
1,089,972 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,689 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had eye inflammation or uveitis after certain eye injections.I have high eye pressure or glaucoma not controlled by medication.I have eye conditions that could affect eye implant procedures.I was diagnosed with wet age-related macular degeneration less than 9 months ago.I have scarring or tissue loss in the center of my retina.I had cataract surgery without issues in the last 3 months or plan to during the study.My eyes can be clearly examined and dilated enough for tests.I do not have any active eye infections or inflammation.I do not have eye conditions that could worsen my vision during the study.I have CNV due to AMD.My vision loss is mainly due to wet AMD, with specific vision test scores.I have a history of cancer.I have had a condition where my lymphocytes grow abnormally.I have a significant bleed under my retina affecting my central vision.I have had previous treatments for my eye condition.I have had treatments with eye injections or implants.I have had eye problems like bleeding inside the eye, retina detachment, glaucoma surgery, or corneal transplant.I haven't had cancer in the last 5 years, except for skin cancer.I do not have a natural lens in my eye or have had specific laser eye surgery.I have had or plan to have eye surgery during the study.I have a tear in the retina affecting my central vision.I have had a torn retina or a break in the retina's edge within the last 3 months.I haven't taken anti-VEGF drugs in the last month.My CNV is not due to age-related macular degeneration.I haven't been in a trial for anti-VEGF drugs, except ranibizumab, aflibercept, or faricimab, in the last 6 months.I have been treated with brolucizumab before.I have had gene therapy for wet AMD before.My vision loss is solely due to age-related macular degeneration.I've had at least two eye injections for wet AMD, with the last one over 21 days ago.My vision loss is mainly due to wet AMD, scoring 34-73 on a vision chart.I have not had, or it's been 2 months since my last, anti-VEGF treatment.I've responded to previous eye injections for my condition.My vision loss is mainly due to wet AMD, and my vision score is between 78 to 34.I have CNV due to AMD.I have not had anti-VEGF eye injections, or it's been 2 months since my last one.My vision loss is solely due to age-related macular degeneration.
Research Study Groups:
This trial has the following groups:- Group 1: Part 2: Port Delivery with Low Dose
- Group 2: Part 3: Port Delivery with High Dose
- Group 3: Part 3: Port Delivery with Low Dose
- Group 4: Part 2: Port Delivery with High Dose
- Group 5: Part 3: Port Delivery with Ranibizumab
- Group 6: Part 1: Intravitreal Injections
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current patient population enrolled in this experiment?
"This study, sponsored by Hoffmann-La Roche and conducted in two locations (Associated Retina Consultants in Phoenix, Arizona and the Retina Center of New jersey in Bloomfield), requires 251 participants who meet specific inclusion criteria."
Answered by AI
How many medical centers are administering this clinical trial?
"Patients can apply to this trial at Associated Retina Consultants in Phoenix, AZ; Retina Center of New jersey in Bloomfield, NJ; Southeast Retina Center in Augusta, GA and 8 other sites."
Answered by AI
Has the FDA greenlighted RO7250284 for public use?
"Taking into account the limited evidence of efficacy and safety in Phase 1 trials, RO7250284 received a score of 1."
Answered by AI
Are investigators currently accepting participants for this clinical investigation?
"Affirmative. The clinicaltrials.gov database attests that this research study, which was posted on October 28th 2020, is actively seeking volunteers. A total of 251 patients will be recruited across 8 trial sites."
Answered by AI
Who else is applying?
What state do they live in?
Maryland
California
How old are they?
18 - 65
What site did they apply to?
Associated Retina Consultants
Mid Atlantic Retina - Wills Eye Hospital
What portion of applicants met pre-screening criteria?
Met criteria
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