Phase
Condition
Macular Degeneration
Geographic Atrophy
Treatment
BI 771716
Sham comparator to BI 771716
Pegcetacoplan
Clinical Study ID
Ages > 50 All Genders
Study Summary
Eligibility Criteria
Inclusion
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) and men able to father a child 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 is provided in the participant information.
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)
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 72 subfoveal lesions in the entire trial1 (72 is 40% of the total trial population of 180 participants). No more than 72 participants with subfoveal GA lesions should be enrolled. After the maximum of 72 participants is reached, then any participants with subfoveal GA lesions should not be enrolled
Best Corrected Visual Acuity (BCVA) in the fellow eye must have a better BCVA compared to the study eye
BCVA letter score of ≥24 letters, using the early trial diabetic retinopathy study (ETDRS) chart in the study eye (equivalent to ≥20/320 on the Snellen chart) Note: If both eyes are eligible, investigator is to select the eye with worst BCVA at the baseline visit to be the study eye
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 will be allowed until a maximum is reached of 72 participants with fellow eye eAMD in the entire trial2 (72 is 40% of the total trial population of 180 participants). No more than 72 participants with fellow eye eAMD should be enrolled. After the maximum of 72 participants is reached, then any participants with fellow eye eAMD should be excluded
Previously received treatment in either eye for GA secondary to AMD within 4 months or 5 half-lives prior to screening, whichever is longer
Previous trial participation receiving oral medication or intravitreal trial medication in the study eye for GA secondary to AMD within 6 months or 5 half-lives prior to screening, whichever is longer
Previously received gene therapy or cell therapy
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 screening in the study eye
further exclusion criteria apply
Study Design
Connect with a study center
Emanuelli Research & Development Center
Arecibo, 00612
Puerto RicoSite Not Available
Associated Retina Consultants
Gilbert, Arizona 85297
United StatesSite Not Available
Associated Retina Consultants, Ltd.
Phoenix, Arizona 85020
United StatesSite Not Available
Phoenix Retina Associates
Phoenix, Arizona 85050
United StatesSite Not Available
Retina Macula Institute of Arizona
Scottsdale, Arizona 85255
United StatesSite Not Available
Barnet Dulaney Perkins Eye Center
Sun City, Arizona 85351
United StatesSite Not Available
Global Research Management
Glendale, California 91204
United StatesActive - Recruiting
Retina Associates of Southern California
Huntington Beach, California 92647
United StatesSite Not Available
Retinal Consultants Medical Group, Inc
Modesto, California 95356
United StatesSite Not Available
Aesthetic Eye Care Institute
Newport Beach, California 92663
United StatesSite Not Available
Eye Research Foundation
Newport Beach, California 92663
United StatesActive - Recruiting
Retina Consultants of San Diego
Poway, California 92064
United StatesActive - Recruiting
Retinal Consultants Medical Group
Sacramento, California 95825
United StatesActive - Recruiting
Orange County Retina
Santa Ana, California 92705
United StatesSite Not Available
Bay Area Retina Associates - Walnut Creek
Walnut Creek, California 94598
United StatesActive - Recruiting
Colorado Retina Associates
Lakewood, Colorado 80228
United StatesSite Not Available
Connecticut Eye Consultants, PC
Danbury, Connecticut 06810
United StatesSite Not Available
Retina Group of Florida
Fort Lauderdale, Florida 33308
United StatesSite Not Available
Eye Associates of Pinellas
Pinellas Park, Florida 33782
United StatesSite Not Available
Rand Eye Institute
Pompano Beach, Florida 33064
United StatesSite Not Available
Retina Vitreous Associates of FL
Saint Petersburg, Florida 33711
United StatesSite Not Available
Retina Vitreous Associates of Florida
Saint Petersburg, Florida 33711
United StatesSite Not Available
Southeast Retina Center, PC
Augusta, Georgia 30909
United StatesActive - Recruiting
University Retina and Macula Associates
Lemont, Illinois 60439
United StatesSite Not Available
Illinois Retina Associates - Oak Park
Oak Park, Illinois 60304
United StatesSite Not Available
Butchertown Clinical Trials
Louisville, Kentucky 40206
United StatesSite Not Available
Mid Atlantic Retina Specialists
Hagerstown, Maryland 21740
United StatesSite Not Available
Ophthalmic Consultants of Boston
Boston, Massachusetts 02114
United StatesSite Not Available
Retina Consultants of Minnesota
Edina, Minnesota 55435
United StatesActive - Recruiting
Mississippi Retina Associates
Madison, Mississippi 39110
United StatesActive - Recruiting
University of Missouri Health System
Columbia, Missouri 65212
United StatesSite Not Available
Envision Ocular, LLC
Bloomfield, New Jersey 07003
United StatesSite Not Available
Eye Associates of New Mexico
Albuquerque, New Mexico 87109
United StatesSite Not Available
Long Island Vitreoretinal Consultants - Westbury
Westbury, New York 11590
United StatesSite Not Available
Verum Research, LLC
Eugene, Oregon 97401
United StatesActive - Recruiting
Mid Atlantic Retina - Bethlehem
Bethlehem, Pennsylvania 18017
United StatesSite Not Available
Mid Atlantic Retina
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Charleston Neuroscience Institute - Charleston
Charleston, South Carolina 29414
United StatesActive - Recruiting
Retina Consultants of Charleston
Charleston, South Carolina 29414
United StatesSite Not Available
Charles Retina Institute
Germantown, Tennessee 38138
United StatesSite Not Available
Tennessee Retina
Nashville, Tennessee 37203
United StatesActive - Recruiting
Austin Clinical Research, LLC
Austin, Texas 78750
United StatesActive - Recruiting
Retina Consultants of Texas-Beaumont-70319
Beaumont, Texas 77707
United StatesSite Not Available
Retina Consultants of Texas-Bellaire-67493
Bellaire, Texas 77401
United StatesSite Not Available
Retina Foundation of the Southwest
Dallas, Texas 75231
United StatesActive - Recruiting
Retina Consultants of Texas - Katy
Katy, Texas 77494
United StatesSite Not Available
Dallas Retina Center
Plano, Texas 75024
United StatesSite Not Available
Red River Research Partners, LLC
Plano, Texas 75024
United StatesSuspended
Retina Consultants of Texas-San Antonio-70189
San Antonio, Texas 78251
United StatesSite Not Available
Retinal Consultants of San Antonio
San Antonio, Texas 78240
United StatesSite Not Available
Retina Consultants of Texas - Schertz
Schertz, Texas 78154
United StatesActive - Recruiting
Retina Consultants of Texas-The Woodlands-67575
The Woodlands, Texas 77384
United StatesSite Not Available
Strategic Clinical Research Group
Weatherford, Texas 76087
United StatesSite Not Available
Retina Associates of Utah
Salt Lake City, Utah 84107
United StatesSite Not Available
Piedmont Eye Center
Lynchburg, Virginia 24502
United StatesSite Not Available
Spokane Eye Clinic
Spokane, Washington 99204
United StatesSite Not Available
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