Phase
Condition
Macular Degeneration
Geographic Atrophy
Treatment
Sham comparator to BI 771716
Pegcetacoplan
BI 771716
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) 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
Study Design
Connect with a study center
Emanuelli Research & Development Center
Arecibo, 612
Puerto RicoSite Not Available
Associated Retina Consultants
Gilbert, Arizona 85297
United StatesSite Not Available
Associated Retina Consultants, Ltd.
Phoenix, Arizona 85020
United StatesActive - Recruiting
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
Associated Retina Consultants
Gilbert 5295903, Arizona 5551752 85297
United StatesSite Not Available
Associated Retina Consultants, Ltd.
Phoenix 5308655, Arizona 5551752 85020
United StatesSite Not Available
Phoenix Retina Associates
Phoenix 5308655, Arizona 5551752 85050
United StatesSite Not Available
Retina Macula Institute of Arizona
Scottsdale 5313457, Arizona 5551752 85255
United StatesSite Not Available
Global Research Management
Glendale, California 91204
United StatesSite Not Available
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 StatesSite Not Available
Retina Consultants of San Diego
Poway, California 92064
United StatesSite Not Available
Retinal Consultants Medical Group
Sacramento, California 95825
United StatesSite Not Available
Orange County Retina
Santa Ana, California 92705
United StatesSite Not Available
Bay Area Retina Associates - Walnut Creek
Walnut Creek, California 94598
United StatesSite Not Available
Global Research Management
Glendale 5352423, California 5332921 91204
United StatesSite Not Available
Retina Associates of Southern California
Huntington Beach 5358705, California 5332921 92647
United StatesSite Not Available
Retinal Consultants Medical Group, Inc
Modesto 5373900, California 5332921 95356
United StatesSite Not Available
Eye Research Foundation
Newport Beach 5376890, California 5332921 92663
United StatesSite Not Available
Retina Consultants of San Diego
Poway 5384690, California 5332921 92064
United StatesSite Not Available
Retinal Consultants Medical Group
Sacramento 5389489, California 5332921 95825
United StatesSite Not Available
Bay Area Retina Associates - Walnut Creek
Walnut Creek 5406990, California 5332921 94598
United StatesSite Not Available
Colorado Retina Associates
Lakewood, Colorado 80228
United StatesSite Not Available
Colorado Retina Associates
Lakewood 5427946, Colorado 5417618 80228
United StatesSite Not Available
Connecticut Eye Consultants, PC
Danbury, Connecticut 06810
United StatesSite Not Available
Retina Group of New England, PC
Waterford, Connecticut 06385
United StatesSite Not Available
Connecticut Eye Consultants, PC
Danbury 4832353, Connecticut 4831725 06810
United StatesSite Not Available
Retina Group of New England, PC
Waterford 8480031, Connecticut 4831725 06385
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
Rand Eye Institute
Deerfield Beach 4153071, Florida 4155751 33064
United StatesSite Not Available
Retina Group of Florida
Fort Lauderdale 4155966, Florida 4155751 33308
United StatesSite Not Available
Eye Associates of Pinellas
Pinellas Park 4168630, Florida 4155751 33782
United StatesSite Not Available
Rand Eye Institute
Pompano Beach 4169014, Florida 4155751 33064
United StatesSite Not Available
Retina Vitreous Associates of Florida
St. Petersburg 4171563, Florida 4155751 33711
United StatesSite Not Available
Southeast Retina Center, PC
Augusta, Georgia 30909
United StatesSite Not Available
Southeast Retina Center, PC
Augusta 4180531, Georgia 4197000 30909
United StatesSite Not Available
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
University Retina and Macula Associates
Lemont 4899581, Illinois 4896861 60439
United StatesSite Not Available
Illinois Retina Associates - Oak Park
Oak Park 4904381, Illinois 4896861 60304
United StatesSite Not Available
Butchertown Clinical Trials
Louisville, Kentucky 40206
United StatesSite Not Available
Butchertown Clinical Trials
Louisville 4299276, Kentucky 6254925 40206
United StatesSite Not Available
Mid Atlantic Retina Specialists
Hagerstown, Maryland 21740
United StatesSite Not Available
Mid Atlantic Retina Specialists
Hagerstown 4357141, Maryland 4361885 21740
United StatesSite Not Available
Ophthalmic Consultants of Boston
Boston, Massachusetts 02114
United StatesSite Not Available
Ophthalmic Consultants of Boston
Boston 4930956, Massachusetts 6254926 02114
United StatesSite Not Available
Retina Consultants of Minnesota
Edina, Minnesota 55435
United StatesSite Not Available
Retina Consultants of Minnesota
Edina 5025264, Minnesota 5037779 55435
United StatesSite Not Available
Mississippi Retina Associates
Madison, Mississippi 39110
United StatesSite Not Available
Mississippi Retina Associates
Madison 4434663, Mississippi 4436296 39110
United StatesSite Not Available
University of Missouri Health System
Columbia, Missouri 65212
United StatesSite Not Available
University of Missouri Health System
Columbia 4381982, Missouri 4398678 65212
United StatesSite Not Available
Envision Ocular, LLC
Bloomfield, New Jersey 07003
United StatesSite Not Available
Envision Ocular, LLC
Bloomfield 5095779, New Jersey 5101760 07003
United StatesSite Not Available
Eye Associates of New Mexico
Albuquerque, New Mexico 87109
United StatesSite Not Available
Eye Associates of New Mexico
Albuquerque 5454711, New Mexico 5481136 87109
United StatesSite Not Available
Long Island Vitreoretinal Consultants - Westbury
Westbury, New York 11590
United StatesSite Not Available
Long Island Vitreoretinal Consultants - Westbury
Westbury 5144040, New York 5128638 11590
United StatesSite Not Available
Verum Research, LLC
Eugene, Oregon 97401
United StatesSite Not Available
Verum Research, LLC
Eugene 5725846, Oregon 5744337 97401
United StatesSite Not Available
Mid Atlantic Retina - Bethlehem
Bethlehem, Pennsylvania 18017
United StatesSite Not Available
Mid Atlantic Retina
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Mid Atlantic Retina - Bethlehem
Bethlehem 5180225, Pennsylvania 6254927 18017
United StatesSite Not Available
Charleston Neuroscience Institute - Charleston
Charleston, South Carolina 29414
United StatesSite Not Available
Retina Consultants of Charleston
Charleston, South Carolina 29414
United StatesSite Not Available
Charleston Neuroscience Institute - Charleston
Charleston 4574324, South Carolina 4597040 29414
United StatesSite Not Available
Charles Retina Institute
Germantown, Tennessee 38138
United StatesSite Not Available
Tennessee Retina
Nashville, Tennessee 37203
United StatesSite Not Available
Charles Retina Institute
Germantown 4624601, Tennessee 4662168 38138
United StatesSite Not Available
Tennessee Retina
Nashville 4644585, Tennessee 4662168 37203
United StatesSite Not Available
Austin Clinical Research, LLC
Austin, Texas 78750
United StatesSite Not Available
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 StatesSite Not Available
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 StatesSite Not Available
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 StatesActive - Recruiting
Retina Consultants of Texas - Schertz
Schertz, Texas 78154
United StatesSite Not Available
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
Austin Clinical Research, LLC
Austin 4671654, Texas 4736286 78750
United StatesSite Not Available
Retina Consultants of Texas-Beaumont-70319
Beaumont 4672989, Texas 4736286 77707
United StatesSite Not Available
Retina Consultants of Texas-Bellaire-67493
Bellaire 4673353, Texas 4736286 77401
United StatesSite Not Available
Retina Foundation of the Southwest
Dallas 4684888, Texas 4736286 75231
United StatesSite Not Available
Retina Consultants of Texas - Katy
Katy 4702732, Texas 4736286 77494
United StatesSite Not Available
Red River Research Partners, LLC
Plano 4719457, Texas 4736286 75024
United StatesSite Not Available
Retinal Consultants of San Antonio
San Antonio 4726206, Texas 4736286 78240
United StatesSite Not Available
Retina Consultants of Texas - Schertz
Schertz 4727326, Texas 4736286 78154
United StatesSite Not Available
Retina Consultants of Texas-The Woodlands-67575
The Woodlands 4736476, Texas 4736286 77384
United StatesSite Not Available
Retina Associates of Utah
Salt Lake City, Utah 84107
United StatesSite Not Available
Retina Associates of Utah
Salt Lake City 5780993, Utah 5549030 84107
United StatesSite Not Available
Piedmont Eye Center
Lynchburg, Virginia 24502
United StatesSite Not Available
Piedmont Eye Center
Lynchburg 4771075, Virginia 6254928 24502
United StatesSite Not Available
Spokane Eye Clinic
Spokane, Washington 99204
United StatesSite Not Available
Spokane Eye Clinic
Spokane 5811696, Washington 5815135 99204
United StatesSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.