Active — Not RecruitingPhase 1/2

Study of Zifibancimig in Participants With Neovascular Age-related Macular Degeneration

United States, Puerto Rico177 participantsStarted 2020-10-28

Plain-language summary

This is a first in-human study to investigate the safety, tolerability and efficacy of zifibancimig administered through intravitreal (IVT) injections and via the port delivery (PD) implant in participants with neovascular age-related macular degeneration (nAMD).

Who can participate

Age range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Part 1, Part 2 and Part 3 Inclusion Criteria: * Willing to allow AH collection Part 1 and Part 2 Ocular Inclusion Criteria for Study Eye: * Choroidal neovascularization (CNV) exclusively due to age-related macular degeneration (AMD) * Anti-vascular endothelial growth factor (VEGF) or anti-VEGF/Angiopoietin-2 (Ang-2) IVT treatment-naïve, or pre-treated with anti-VEGF or anti-VEGF/Ang-2 no less than two months prior to Day 1 * Sufficiently clear ocular media and adequate pupillary dilatation to allow for analysis and grading by the central reading center of fundus photography (FP), fluorescein angiography (FA), fundus autofluorescence (FAF), and spectral domain optical coherence tomography (SD-OCT) images * Decreased BCVA attributable primarily to nAMD, with BCVA letter score of 78 to 34 letters (inclusive) on 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 Part 3 Ocular Inclusion Criteria for Study Eye: * CNV exclusively due to AMD * Diagnosis of nAMD within 36 months prior to the screening visit * Previous treatment with at least one IVT anti-VEGF or anti-VEGF/Ang-2 administrations IVT for nAMD. The last IVT administration must have occurred at least 21 days prior to the screening visit * Demonstrated response to prior IVT anti-VEGF or anti-VEGF/Ang-2 treatment since diagnosis * Availability of historical VA data prior to the first anti-VEGF or anti-VEGF/Ang-2 treatment for …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Participants With Ocular and Systemic (Non-ocular) Adverse Events (AEs)

Timeframe: Part 1: Baseline up to Week 24; Parts 2 & 3: Baseline up to Week 48

Percentage of Participants With Ocular AEs During the Post-operative and Follow-up Periods

Timeframe: Parts 2 and 3: From Day 1 to Week 4 and during follow-up period (up to Week 48)

Percentage of Participants With Adverse Events of Special Interest (AESIs) Including Ocular AESIs

Timeframe: Part 1: Baseline up to Week 24; Parts 2 and 3: Baseline up to Week 48

Percentage of Participants With Ocular AESIs During the Post-operative and Follow-up Periods

Timeframe: Parts 2 and 3: From Day 1 to Week 4 and during follow-up period (up to Week 48)

Duration of Ocular AESIs

Timeframe: Part 1: Baseline up to Week 24; Parts 2 and 3: Baseline up to Week 48

Duration of Ocular AESIs During the Post-operative and Follow-up Periods

Timeframe: Parts 2 and 3: From Day 1 to Week 4 and during follow-up period (up to Week 48)

Trial details

NCT IDNCT04567303

SponsorHoffmann-La Roche

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-08-01

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