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Study of Zifibancimig in Participants With Neovascular Age-related Macular Degeneration
Sponsor: Hoffmann-La Roche
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
Conditions
Interventions
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.
Ranibizumab
Participants will receive ranibizumab 100 mg/mL through the PD implant
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