Zifibancimig for Age-Related Macular Degeneration

(BURGUNDY Trial)

Recruiting at 50 trial locations

Overseen By BP41670 https://forpatients.roche.com/

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

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

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

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.

What safety data exists for Zifibancimig (Ranibizumab) in humans?

A systematic review and meta-analysis found that ranibizumab, which is related to Zifibancimig, has been studied for safety in treating age-related macular degeneration, showing it is generally safe for human use. ^{1 2 3 4 5}

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Port Delivery Platform (Device)
• Ranibizumab (Anti-VEGF Monoclonal Antibody)
• RO7250284 (Anti-VEGF Monoclonal Antibody)
• Zifibancimig (Anti-VEGF Monoclonal Antibody)

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.

Participant Groups

Group I: Part 3: Port Delivery with Low Dose Experimental Treatment 2 Interventions

Zifibancimig administered at a low dose through the PD implant.

Group II: Part 3: Port Delivery with High Dose Experimental Treatment 2 Interventions

Zifibancimig administered at a high dose through the PD implant.

Group III: Part 2: Port Delivery with Low Dose Experimental Treatment 2 Interventions

Zifibancimig administered at a low dose through the PD implant.

Group IV: Part 2: Port Delivery with High Dose Experimental Treatment 2 Interventions

Zifibancimig administered at a high dose through the PD implant.

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

Zifibancimig administered in ascending dose levels through IVT injections.

Group VI: Part 3: Port Delivery with Ranibizumab Active Control 2 Interventions

100 milligrams/milliliter (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

Findings from Research

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Macular neovascularization lesion type and vision outcomes in neovascular age-related macular degeneration: post hoc analysis of HARBOR. [2022]

2. England 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. [2023]

3. England 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Effects of Aflibercept for Neovascular Age-Related Macular Degeneration: A Systematic Review and Meta-Analysis of Observational Comparative Studies. [2018]

5. England pubmed.ncbi.nlm.nih.gov

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