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

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Macular Degeneration

In brief

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).

Key facts

Study ID

NCT04567303

Run by

Hoffmann-La Roche

People needed

177

Starts

2020-10-28

Expected to finish

2026-08-01

Last updated by the study team

2026-05-06

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 nAMD
• Sufficiently clear ocular media and adequate pupillary dilatation to allow for analysis and grading
• Decreased BCVA attributable primarily to nAMD with letter score of 78 to 34 letters (inclusive) or better on ETDRS-like charts
• Ocular Exclusion Criteria for Study Eye:
• History of vitrectomy surgery, submacular surgery, other intraocular surgery, or any planned surgical intervention during the study period
• Cataract surgery without complications within three months preceding the screening visit or planned during the study period
• Aphakia or absence of the posterior capsule. Previous violation of the posterior capsule is also an exclusion criterion, unless it occurred as a result of yttrium-aluminum garnet laser posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation
• Prior macular treatment with verteporfin, external beam radiation therapy, transpupillary thermotherapy, or any type of laser photocoagulation
• Prior treatment with IVT corticosteroids or implant (e.g., triamcinolone, ozurdex, iluvien)
• Subretinal hemorrhage >50% of the total lesion area and/or involving the fovea
• Subfoveal fibrosis or subfoveal atrophy
• Retinal pigment epithelial tear involving the macula

Where it is running

• Barnet Dulaney Perkins Eye Center — Mesa, Arizona, United States
• Associated Retina Consultants — Phoenix, Arizona, United States
• The Retina Partners — Encino, California, United States
• Retinal Consultants Med Group — Sacramento, California, United States
• Orange County Retina Med Group — Santa Ana, California, United States
• Southwest Retina Consultants — Durango, Colorado, United States
• Retina Vitreous Assoc of FL — St. Petersburg, Florida, United States
• Southern Vitreoretinal Assoc — Tallahassee, Florida, United States
• Retina Associates of Florida, LLC — Tampa, Florida, United States
• Southeast Retina Center — Augusta, Georgia, United States
• University Retina and Macula Associates, PC — Oak Forest, Illinois, United States
• Maine Eye Center — Portland, Maine, United States
• Johns Hopkins Med — Baltimore, Maryland, United States
• Retina Group of Washington — Chevy Chase, Maryland, United States
• Cumberland Valley Retina Consultants — Hagerstown, Maryland, United States
• Foundation for Vision Research — Grand Rapids, Michigan, United States
• Associated Retinal Consultants — Royal Oak, Michigan, United States
• VitreoRetinal Surgery, PLLC. — Saint Louis Park, Minnesota, United States
• The Retina Institute — St Louis, Missouri, United States
• Sierra Eye Associates — Reno, Nevada, United States
• Envision Ocular, LLC — Bloomfield, New Jersey, United States
• Retina Vit Surgeons/Central NY — Liverpool, New York, United States
• Duke Eye Center — Durham, North Carolina, United States
• Graystone Eye — Hickory, North Carolina, United States
• OSU Eye Physicians & Surgeons — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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