A Study to Test Whether BI 771716 Helps People With an Advanced Form of Age-related Macular Degeneration (AMD) Called Geographic Atrophy
NCT ID: NCT06722157
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
202 participants
INTERVENTIONAL
2025-01-06
2026-10-16
Brief Summary
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In this study, participants receive either BI 771716 or pegcetacoplan as injections in the eye.
Participants are in the study for a little longer than a year and visit the study site every 4 weeks. At the visits, the study doctor checks the eyes of the participants. The results are compared between the groups of participants to see whether the treatment works. The study doctor also regularly checks participants' health and takes note of any unwanted effects.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm A: BI 771716
BI 771716
BI 771716
Arm B: BI 771716 and Sham comparator
BI 771716
BI 771716
Sham comparator to BI 771716
Sham comparator to BI 771716
Arm C: Pegcetacoplan
Pegcetacoplan
Pegcetacoplan
Interventions
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BI 771716
BI 771716
Pegcetacoplan
Pegcetacoplan
Sham comparator to BI 771716
Sham comparator to BI 771716
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 is reached of 36 subfoveal lesions in the entire trial (36 is 20% of the total trial population of 180 participants). No more than 36 participants with subfoveal GA lesions should be enrolled. After the maximum of 36 participants is reached, then any participants with subfoveal GA lesions should not be enrolled
* 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
Exclusion Criteria
* Exudative neovascular AMD (eAMD) in the study eye
\-- Note: eAMD in the fellow eye is allowed
* 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
50 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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Associated Retina Consultants
Gilbert, Arizona, United States
Associated Retina Consultants, Ltd.
Phoenix, Arizona, United States
Phoenix Retina Associates
Phoenix, Arizona, United States
Retina Macula Institute of Arizona
Scottsdale, Arizona, United States
Global Research Management
Glendale, California, United States
Retina Associates of Southern California
Huntington Beach, California, United States
Retinal Consultants Medical Group, Inc
Modesto, California, United States
Eye Research Foundation
Newport Beach, California, United States
Retina Consultants of San Diego
Poway, California, United States
Retinal Consultants Medical Group
Sacramento, California, United States
Bay Area Retina Associates - Walnut Creek
Walnut Creek, California, United States
Colorado Retina Associates
Lakewood, Colorado, United States
Connecticut Eye Consultants, PC
Danbury, Connecticut, United States
Retina Group of New England, PC
Waterford, Connecticut, United States
Rand Eye Institute
Deerfield Beach, Florida, United States
Retina Group of Florida
Fort Lauderdale, Florida, United States
Eye Associates of Pinellas
Pinellas Park, Florida, United States
Retina Vitreous Associates of Florida
St. Petersburg, Florida, United States
Southeast Retina Center, PC
Augusta, Georgia, United States
University Retina and Macula Associates
Lemont, Illinois, United States
Illinois Retina Associates - Oak Park
Oak Park, Illinois, United States
Butchertown Clinical Trials
Louisville, Kentucky, United States
Mid Atlantic Retina Specialists
Hagerstown, Maryland, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States
Retina Consultants of Minnesota
Edina, Minnesota, United States
Mississippi Retina Associates
Madison, Mississippi, United States
University of Missouri Health System
Columbia, Missouri, United States
Envision Ocular, LLC
Bloomfield, New Jersey, United States
Eye Associates of New Mexico
Albuquerque, New Mexico, United States
Long Island Vitreoretinal Consultants - Westbury
Westbury, New York, United States
Verum Research, LLC
Eugene, Oregon, United States
Mid Atlantic Retina - Bethlehem
Bethlehem, Pennsylvania, United States
Charleston Neuroscience Institute - Charleston
Charleston, South Carolina, United States
Tennessee Retina
Nashville, Tennessee, United States
Austin Clinical Research, LLC
Austin, Texas, United States
Retina Consultants of Texas-Beaumont-70319
Beaumont, Texas, United States
Retina Consultants of Texas-Bellaire-67493
Bellaire, Texas, United States
Retina Foundation of the Southwest
Dallas, Texas, United States
Retina Consultants of Texas - Katy
Katy, Texas, United States
Red River Research Partners, LLC
Plano, Texas, United States
Retinal Consultants of San Antonio
San Antonio, Texas, United States
Retina Consultants of Texas - Schertz
Schertz, Texas, United States
Retina Consultants of Texas-The Woodlands-67575
The Woodlands, Texas, United States
Retina Associates of Utah
Salt Lake City, Utah, United States
Piedmont Eye Center
Lynchburg, Virginia, United States
Spokane Eye Clinic
Spokane, Washington, United States
Countries
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Related Links
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Related Info
Other Identifiers
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U1111-1308-7923
Identifier Type: REGISTRY
Identifier Source: secondary_id
1497-0002
Identifier Type: -
Identifier Source: org_study_id