What side effects are associated with this type of intervention?

Common treatments for Age-Related Macular Degeneration (AMD) include anti-angiogenic agents such as ranibizumab, aflibercept, and bevacizumab, which target abnormal blood vessel growth in the retina. Known side effects of these treatments can include eye pain, increased intraocular pressure, vitreous floaters, and inflammation. In rare cases, more severe complications such as retinal detachment, endophthalmitis, and cataracts may occur. Regular monitoring by an ophthalmologist is essential to manage and mitigate these risks.

What prior FDA approvals exist?

Several anti-angiogenic agents have been approved by the FDA for the treatment of neovascular (wet) Age-Related Macular Degeneration (AMD). These include Ranibizumab (Lucentis), Bevacizumab (Avastin), and Aflibercept (Eylea). These drugs work by inhibiting vascular endothelial growth factor (VEGF), which plays a critical role in the formation of abnormal blood vessels in the retina. Ranibizumab and Bevacizumab are monoclonal antibodies that bind to VEGF, while Aflibercept acts as a decoy receptor for VEGF. These treatments have been shown to reduce retinal swelling, prevent vision loss, and in some cases, improve vision in patients with wet AMD.

What other types of research exist?

Promising alternatives to Zifibancimig for Age-Related Macular Degeneration (AMD) include: 1) Faricimab, a bispecific antibody targeting both VEGF-A and Ang-2, which has shown positive results in clinical trials. 2) Brolucizumab, a single-chain antibody fragment that inhibits VEGF, offering longer dosing intervals. 3) Gene therapy options like RGX-314, which delivers a gene encoding for an anti-VEGF protein, potentially reducing the need for frequent injections. These alternatives are in various stages of clinical development and have shown promise in improving vision outcomes and reducing treatment burden for AMD patients.

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Anti-VEGF Monoclonal Antibody

Zifibancimig for Age-Related Macular Degeneration (BURGUNDY Trial)

Phase 1 & 2

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.

Must not have

History of uveitis, including history of any intraocular inflammation following intravitreal anti-VEGFor anti-VEGF/Ang-2 injections

Concurrent conjunctival, Tenon's capsule, and/or scleral condition in the supero-temporal quadrant of the eye (e.g., scarring, thinning, mass) that may affect the implantation, subsequent tissue coverage, and refill-exchange procedure of the PD implant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up part 3: baseline to week 48

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment called zifibancimig for people with a serious eye condition known as neovascular age-related macular degeneration (nAMD). The treatment is given either as an injection into the eye or through a small implant. It works by stopping harmful blood vessels from growing in the eye, which can help protect or improve vision.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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I have CNV due to AMD.

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My vision loss is mainly due to wet AMD, with specific vision test scores.

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My vision loss is solely due to age-related macular degeneration.

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My vision loss is mainly due to wet AMD, scoring 34-73 on a vision chart.

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I've responded to previous eye injections for my condition.

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My vision loss is mainly due to wet AMD, and my vision score is between 78 to 34.

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I have CNV due to AMD.

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My vision loss is solely due to age-related macular degeneration.

Exclusion Criteria

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

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I have had eye inflammation or uveitis after certain eye injections.

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I have eye conditions that could affect eye implant procedures.

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

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I do not have any active eye infections or inflammation.

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I have a history of cancer.

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I have had a condition where my lymphocytes grow abnormally.

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I have a significant bleed under my retina affecting my central vision.

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I have had previous treatments for my eye condition.

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I have had treatments with eye injections or implants.

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I have had eye problems like bleeding inside the eye, retina detachment, glaucoma surgery, or corneal transplant.

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I have had or plan to have eye surgery during the study.

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I have a tear in the retina affecting my central vision.

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I have been treated with brolucizumab before.

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I have had gene therapy for wet AMD before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ part 3: baseline to week 48

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~part 3: baseline to week 48

This trial's timeline: 3 weeks for screening, Varies for treatment, and part 3: baseline to week 48 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change from Baseline in Early Treatment Diabetic Retinopathy Study - Best Corrected Visual Acuity (ETDRS-BCVA) Score

Secondary study objectives

Percentage of Participants who Gained or Lost ≥15, ≥10 ≥5 or ≥0 letters in ETDRS-BCVA score from Baseline

Awards & Highlights

No Placebo-Only Group

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

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.

0 / 22Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Age-Related Macular Degeneration (AMD) include anti-angiogenic agents, which inhibit the growth of abnormal blood vessels in the retina. This is important for AMD patients because these abnormal vessels can leak fluid or blood, causing vision loss. By preventing this vascular growth, anti-angiogenic treatments help to stabilize or improve vision, thereby preserving the quality of life for those affected by AMD.