New eye drug takes on leading cause of blindness in the elderly
NCT ID NCT06722157
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new medicine called BI 771716 for geographic atrophy, an advanced form of age-related macular degeneration that causes vision loss. About 202 adults aged 50 and older will receive either the new drug or an existing treatment (pegcetacoplan) as eye injections. The goal is to see if BI 771716 can slow the growth of damaged areas in the eye better than the current standard of care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
202 people
The number who actually took part.
- Started
-
Jan 2025
- Expected to finish
-
Oct 2026
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
50 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria * Age at least 50 years old at the time of randomization visit * Signed and dated written informed consent in accordance with International Council on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial * Male or female participants. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of use are provided in the participant information. Male participants must be ready and able to use either a condom or abstinence as contraceptive measures * Diagnosis of geographic atrophy (GA) secondary to age-related macular degeneration (AMD), where the total GA lesion area must be ≥2.5 square millimetres (mm²) and ≤17.5 mm² as measured by Fundus autofluorescence (FAF) * If multiple lesions are present in the study eye, at least 1 lesion must have an area of ≥1.25 mm² * Note: Fellow eye is not required to have GA * Note: subfoveal GA lesions (defined as GA lesions within 1 micron of the foveal center point) will be allowed to be enrolled until a maximum of approximately 60% of participants with subfoveal GA lesions are enrolled. Participants with subfoveal GA lesions already in screening at the time the cap has been reached may be considered for randomization. * Fellow eye must have sufficient visual function compared to the study eye, per the investigator's medical judgment in consultation with the patient, to support the patient's daily functioning * BCVA letter score of ≥24 letters, using the ETDRS chart in the study eye (equivalent to ≥20/320 on the Snellen chart). Note: If both eyes meet eligibility criteria, the eye with the worse visual function per the investigator's medical judgment in consultation with the patient, will be selected as the study eye. If both eyes have similar visual function, the study eye will be selected per the investigator's medical judgment in consultation with the patient * further inclusion criteria apply Exclusion criteria * GA lesions whose area cannot be accurately defined in the study eye * Exudative neovascular AMD (eAMD) in the study eye \-- Note: eAMD in the fellow eye is allowed. However, if the fellow eye is to be considered for microperimetry and other analyses (as defined in the trial statistical analysis plan), then eAMD is not allowed in either eye. * Previously received treatment in the study eye for GA secondary to AMD within 4 months or 5 half-lives prior to baseline, whichever is longer * Previously received an investigational medication (oral or intravitreal) for GA secondary to AMD within 4 months or 5 half-lives prior to baseline, whichever is longer * Currently enrolled in another investigational device or drug trial, or 30 days or 5 half-lives, whichever is longer since ending another investigational device or drug trial(s) or receiving other investigational treatment(s). Any previous use of gene therapy or cell therapy is not permitted * Additional eye disease as follows: * Any eye disease in the study eye that could compromise BCVA * Uncontrolled glaucoma or ocular hypertension with intraocular pressure \>24 millimetre of mercury (mmHg) in study eye * History of high myopia \>8 diopters in the study eye * Anterior segment and vitreous abnormalities that would preclude adequate observation with spectral domain optical coherence tomography in the study eye * Ocular conditions at the discretion of the investigator that might interfere with outcome of the trial in the study eye * Active intraocular inflammation in the study eye * Active infectious conjunctivitis in either eye * Prior vitrectomy surgery in the study eye * History of major intraocular surgeries including major corneal surgery. Uneventful cataract surgery, refractive surgery, oculoplastic surgery, strabismus surgery, and other extraocular surgery may be permitted if they have occurred more than 3 months prior to baseline in the study eye * further exclusion criteria apply
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Geographic atrophy are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Associated Retina Consultants
Gilbert, Arizona, 85297, United States
-
Associated Retina Consultants, Ltd.
Phoenix, Arizona, 85020, United States
-
Austin Clinical Research, LLC
Austin, Texas, 78750, United States
-
Bay Area Retina Associates - Walnut Creek
Walnut Creek, California, 94598, United States
-
Butchertown Clinical Trials
Louisville, Kentucky, 40206, United States
-
Charleston Neuroscience Institute - Charleston
Charleston, South Carolina, 29414, United States
-
Colorado Retina Associates
Lakewood, Colorado, 80228, United States
-
Connecticut Eye Consultants, PC
Danbury, Connecticut, 06810, United States
-
Envision Ocular, LLC
Bloomfield, New Jersey, 07003, United States
-
Eye Associates of New Mexico
Albuquerque, New Mexico, 87109, United States
-
Eye Associates of Pinellas
Pinellas Park, Florida, 33782, United States
-
Eye Research Foundation
Newport Beach, California, 92663, United States
-
Global Research Management
Glendale, California, 91204, United States
-
Illinois Retina Associates - Oak Park
Oak Park, Illinois, 60304, United States
-
Long Island Vitreoretinal Consultants - Westbury
Westbury, New York, 11590, United States
-
Mid Atlantic Retina - Bethlehem
Bethlehem, Pennsylvania, 18017, United States
-
Mid Atlantic Retina Specialists
Hagerstown, Maryland, 21740, United States
-
Mississippi Retina Associates
Madison, Mississippi, 39110, United States
-
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114, United States
-
Phoenix Retina Associates
Phoenix, Arizona, 85050, United States
-
Piedmont Eye Center
Lynchburg, Virginia, 24502, United States
-
Rand Eye Institute
Deerfield Beach, Florida, 33064, United States
-
Red River Research Partners, LLC
Plano, Texas, 75024, United States
-
Retina Associates of Southern California
Huntington Beach, California, 92647, United States
-
Retina Associates of Utah
Salt Lake City, Utah, 84107, United States
-
Retina Consultants of Minnesota
Edina, Minnesota, 55435, United States
-
Retina Consultants of San Diego
Poway, California, 92064, United States
-
Retina Consultants of Texas - Katy
Katy, Texas, 77494, United States
-
Retina Consultants of Texas - Schertz
Schertz, Texas, 78154, United States
-
Retina Consultants of Texas-Beaumont-70319
Beaumont, Texas, 77707, United States
-
Retina Consultants of Texas-Bellaire-67493
Bellaire, Texas, 77401, United States
-
Retina Consultants of Texas-The Woodlands-67575
The Woodlands, Texas, 77384, United States
-
Retina Foundation of the Southwest
Dallas, Texas, 75231, United States
-
Retina Group of Florida
Fort Lauderdale, Florida, 33308, United States
-
Retina Group of New England, PC
Waterford, Connecticut, 06385, United States
-
Retina Macula Institute of Arizona
Scottsdale, Arizona, 85255, United States
-
Retina Vitreous Associates of Florida
St. Petersburg, Florida, 33711, United States
-
Retinal Consultants Medical Group
Sacramento, California, 95825, United States
-
Retinal Consultants Medical Group, Inc
Modesto, California, 95356, United States
-
Retinal Consultants of San Antonio
San Antonio, Texas, 78240, United States
-
Southeast Retina Center, PC
Augusta, Georgia, 30909, United States
-
Spokane Eye Clinic
Spokane, Washington, 99204, United States
-
Tennessee Retina
Nashville, Tennessee, 37203, United States
-
University Retina and Macula Associates
Lemont, Illinois, 60439, United States
-
University of Missouri Health System
Columbia, Missouri, 65212, United States
-
Verum Research, LLC
Eugene, Oregon, 97401, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new eye injection protect vision in geographic atrophy?
- Can genetics predict the worsening of geographic atrophy?
- New eye imaging could reveal hidden clues to vision loss
- A new eye camera may spot stressed cells before vision loss begins
- Gene therapy injection aims to halt blinding eye disease
- Eye imaging showdown: which device measures macular damage best?