Zifibancimig for Age-Related Macular Degeneration

(BURGUNDY Trial)

Recruiting at 60 trial locations

Overseen By Reference Study ID Number: BP41670 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Hoffmann-La Roche

Must be taking: Anti-VEGF

Must not be taking: Corticosteroids, Anti-VEGF-C, Anti-VEGF-D

Disqualifiers: Vitrectomy, Glaucoma, Uveitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 48 weeks

251 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called zifibancimig (also known as RO7250284) for individuals with neovascular age-related macular degeneration (nAMD), a condition that can cause vision loss. Researchers aim to assess the safety and effectiveness of this treatment, delivered either through injections directly into the eye or via a small implant that releases the drug. Participants should have nAMD, have previously received specific eye injections, and experience vision issues primarily due to nAMD. As a Phase 1 and Phase 2 trial, this research seeks to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are currently on anti-VEGF treatments, you must have had your last dose at least two months before starting the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that zifibancimig remains in the early stages of human testing. This study is among the first to assess its safety and tolerability for individuals with age-related macular degeneration (AMD). In contrast, more information exists about ranibizumab, also used in this trial. Ranibizumab has treated similar eye conditions and is generally considered safe. However, some studies indicate that using ranibizumab with a Port Delivery implant in this trial might increase the risk of certain side effects, such as endophthalmitis, an eye infection. This risk is about three times higher than with regular eye injections. Safety is a major focus of this trial, so researchers will closely monitor participants for any issues. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike standard treatments for age-related macular degeneration, which often involve repeated eye injections with drugs like ranibizumab, Zifibancimig offers a novel approach. This treatment is unique because it can be delivered through a PD (port delivery) implant, potentially reducing the frequency of eye injections. Additionally, Zifibancimig works by a different mechanism than existing options, which could provide new benefits for patients. Researchers are particularly interested in how Zifibancimig's different dosage strategies, including low and high doses, might optimize treatment outcomes.

What evidence suggests that this trial's treatments could be effective for age-related macular degeneration?

Research shows that zifibancimig is a new treatment under testing for neovascular age-related macular degeneration (nAMD), a condition affecting vision. In this trial, participants may receive zifibancimig through eye injections or a special implant. The treatment aims to halt the growth of abnormal blood vessels in the eye, a major issue in nAMD. Although zifibancimig remains under study, similar treatments like aflibercept and ranibizumab have successfully treated nAMD. Specifically, ranibizumab proved effective and safe in maintaining stable vision over several years. The success of these similar treatments offers encouragement for zifibancimig's potential. ^{6 7 8 9 10}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I was diagnosed with wet age-related macular degeneration less than 9 months ago.

My eyes can be clearly examined and dilated enough for tests.

Willing to allow AH collection

Exclusion 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Zifibancimig through intravitreal injections and via the Port Delivery implant

48 weeks

Multiple visits for dose administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Port Delivery Platform
• Ranibizumab
• RO7250284
• Zifibancimig

Trial Overview 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.

How Is the Trial Designed?

Group I: Part 3: PD With Low Dose Experimental Treatment 2 Interventions

Zifibancimig administered at a low dose through the PD implant.

Group II: Part 3: PD With High Dose Experimental Treatment 2 Interventions

Zifibancimig administered at a high dose through the PD implant.

Group III: Part 2: PD With Low Dose Experimental Treatment 3 Interventions

Zifibancimig administered at a low dose through the PD implant. At Week 48, refill-exchange with 100 mg/mL of ranibizumab administered through the PD implant.

Group IV: Part 2: PD With High Dose Experimental Treatment 3 Interventions

Zifibancimig administered at a high dose through the PD implant. At Week 48, refill-exchange with 100 milligrams/milliliter (mg/mL) of ranibizumab administered through the PD implant.

Group V: Part 1: IVT Injections Experimental Treatment 1 Intervention

Zifibancimig administered in multiple ascending dose levels through IVT injections.

Group VI: Part 3: PD With Ranibizumab Active Control 1 Intervention

100 mg/mL of ranibizumab administered through the PD implant.

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Published Research Related to This Trial

A systematic review of four randomized controlled trials involving 1544 eyes found that ranibizumab biosimilars are equally effective as the reference ranibizumab in improving visual acuity and retinal thickness for treating neovascular age-related macular degeneration (nAMD).

There were no significant differences in the occurrence of adverse events between the biosimilars and the reference ranibizumab, indicating that the biosimilars are as safe as the original treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of efficacy and meta-analysis of safety of ranibizumab biosimilars relative to reference ranibizumab anti-VEGF therapy for nAMD treatment. Hatamnejad, A., Dadak, R., Orr, S., et al.[2023]

Aflibercept and ranibizumab show similar effectiveness in treating treatment-naïve neovascular age-related macular degeneration (nAMD) over two years, based on a systematic review of 18 studies involving 1697 patients.

Aflibercept may be particularly beneficial for patients with lower initial visual acuity, requiring fewer injections compared to ranibizumab, suggesting it could be a more convenient option for some patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Aflibercept for Neovascular Age-Related Macular Degeneration: A Systematic Review and Meta-Analysis of Observational Comparative Studies. Zhang, Y., Chioreso, C., Schweizer, ML., et al.[2018]

In the VISION-1 trial involving 1186 patients, pegaptanib, a VEGF inhibitor, significantly helped maintain visual acuity in patients with neovascular age-related macular degeneration, with 70% of those receiving the 0.3 mg dose losing fewer than 15 letters of visual acuity compared to 55% in the sham group.

While pegaptanib showed no serious systemic side effects, it did lead to more ocular adverse effects, such as vitreous floaters and inflammation, indicating a need for ongoing improvements in treatment options for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pegaptanib: the first antiangiogenic agent approved for neovascular macular degeneration. Doggrell, SA.[2019]

In a post hoc analysis of the HARBOR trial involving 700 patients with neovascular age-related macular degeneration (nAMD), different types of macular neovascularization (MNV) were associated with varying visual acuity outcomes after treatment with ranibizumab.

Type 1 MNV lesions had the best baseline and 24-month visual acuity, while type 2/mixed lesions showed the greatest improvement in visual acuity after treatment, highlighting the importance of anatomic classification in predicting treatment responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Macular neovascularization lesion type and vision outcomes in neovascular age-related macular degeneration: post hoc analysis of HARBOR. Freund, KB., Staurenghi, G., Jung, JJ., et al.[2022]

In a study of 1027 treatment-naïve patients with neovascular age-related macular degeneration, both ranibizumab and aflibercept showed similar improvements in visual acuity after one year, indicating their comparable efficacy.

Patients treated with aflibercept required 15% fewer injections than those treated with ranibizumab, suggesting that aflibercept may offer a more convenient treatment regimen without compromising visual outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neovascular age-related macular degeneration treated with ranibizumab or aflibercept in the same large clinical setting: visual outcome and number of injections. Rasmussen, A., Sander, B., Larsen, M., et al.[2022]

Citations

1. gene.com gene.com/media/press-releases/15073/2025-08-01/genentechs-susvimo-maintains-vision-over

Genentech: Press Releases | Friday, Aug 1, 2025 Genentech's Susvimo Maintains Vision Over Five Years With Two Refills Per Year in People With Wet Age-Related Macular Degeneration (AMD) ...

2. roche.com roche.com/media/releases/med-cor-2025-08-01

Roche's Susvimo maintains vision over five years with two ... Roche's Susvimo maintains vision over five years with two refills per year in people with neovascular age-related macular degeneration (nAMD).

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3677930/

Long-term effectiveness of ranibizumab for age-related ... Based on the various studies with long-term follow-up, there is good evidence that ranibizumab is an effective, safe, and well-tolerated treatment option for ...

4. lucentis.com lucentis.com/hcp/wamd/efficacy/clinical-trial-results.html

Clinical Trial Efficacy & Results for wAMD Learn about LUCENTIS® (ranibizumab injection) clinical trial results for wet AMD patients here. See full safety for more information.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT00593450?tab=table

NCT00593450 | Comparison of Age-related Macular ... The purpose of the study is to evaluate the relative efficacy and safety of treatment of neovascular AMD with Lucentis on a fixed schedule, Avastin on a fixed ...

6. susvimo-hcp.com susvimo-hcp.com/safety/safety-profile.html

SUSVIMO® (ranibizumab injection) Safety Profile SUSVIMO (ranibizumab injection) is indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD)

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2014/125156s105lbl.pdf

LUCENTIS (ranibizumab injection) label - accessdata.fda.gov The data below reflect exposure to 0.5 mg LUCENTIS in 440 patients with neovascular AMD in Studies AMD-1, AMD-2, and AMD-3, and 259 patients with macular edema ...

8. lucentis.com lucentis.com/hcp/rvo/side-effects/important-safety-information.html

Important Safety Information & Indications LUCENTIS is contraindicated in patients with ocular or periocular infections or known hypersensitivity to ranibizumab or any of the excipients in LUCENTIS.

9. caresource.com caresource.com/documents/medicare-multi-policy-pharmacy-susvimo-20250430.pdf

Safety In the active-controlled trials in AMD,. Susvimo has been associated with a 3-fold higher rate of endophthalmitis than monthly intravitreal.

10. clinicaltrials.gov clinicaltrials.gov/study/NCT01986907

Safety and Tolerability of Ranibizumab in Mono/Bilateral ... The purpose of this study is to evaluate the safety and efficacy of ranibizumab in patients affected by wet age related macular degeneration (wAMD). Official ...