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ACTIVE NOT RECRUITING
NCT04567303
PHASE1/PHASE2

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

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

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).

Official title: A Three-part, Phase I/II Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Zifibancimig Following Intravitreal Administration of Multiple Ascending Doses and Continuous Delivery From the Port Delivery in Patients With Neovascular Age-related Macular Degeneration

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

177

Start Date

2020-10-28

Completion Date

2026-08-01

Last Updated

2026-02-04

Healthy Volunteers

No

Interventions

DRUG

Zifibancimig

Part 1: multiple ascending doses by IVT injection. Each participant will receive zifibancimig at a constant volume of 50 microliter (µL) in the study eye. Part 2: participants will be randomized to one of two dose levels of zifibancimig in the PD implant. Part 3: Participants will receive one of the two dose levels of zifibancimig in the PD implant.

DRUG

Ranibizumab

Participants will receive ranibizumab 100 mg/mL through the PD implant

DEVICE

Port Delivery Platform

Participants will receive intraocular refillable device that is surgically inserted into the eye for continuous delivery of drugs into the vitreous.

Locations (48)

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

Macula Retina Vitreous Research Institute

Torrance, California, United States

Southwest Retina Consultants

Durango, Colorado, United States

Retina Specialty Institute

Pensacola, Florida, 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

The Retina Care Center

Baltimore, Maryland, 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

Midwest Vision Research Foundation

Chesterfield, Missouri, 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

NJ Retina - Teaneck

Teaneck, New Jersey, United States

Retina Vit Surgeons/Central NY

Liverpool, New York, United States

Long Is. Vitreoretinal Consult

Westbury, 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

Mid Atlantic Retina - Wills Eye Hospital

Philadelphia, Pennsylvania, United States

Charleston Neuroscience Inst

Ladson, South Carolina, United States

Carolina Eyecare Physicians

Mt. Pleasant, South Carolina, United States

Charles Retina Institute

Germantown, Tennessee, United States

Southeastern Retina Associates

Knoxville, Tennessee, United States

Tennessee Retina PC.

Nashville, Tennessee, United States

Austin Research Center for Retina

Austin, Texas, United States

Austin Clinical Research LLC

Austin, Texas, United States

Retina Consultants of Texas

Bellaire, Texas, United States

Texas Retina Associates

Dallas, Texas, United States

Retina Consultants of Texas

Houston, Texas, United States

Brown Retina Institute

San Antonio, Texas, United States

Retina Center of Texas

Southlake, Texas, United States

Piedmont Eye Center

Lynchburg, Virginia, United States

Wagner Kapoor Institute

Norfolk, Virginia, United States

Spokane Eye Clinical Research

Spokane, Washington, United States

Emanuelli Research and Development Center LLC

Arecibo, Puerto Rico