Phase
Condition
Geographic Atrophy
Treatment
BI 1584862
Placebo-matching BI 1584862
Clinical Study ID
Ages > 50 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria:
Men and women with at least 1 eye with geographic atrophy (GA) secondary toage-related macular degeneration (AMD) determined by fundus autofluorescence (FAF).The total size of all GA lesions in the study eye (as determined by the independentcentral reading center (CRC)) must be ≥1.25 mm^2 and ≤12.0 mm^2:
If multiple lesions are present in the study eye, at least 1 lesion must havean area of ≥0.5 mm^2
At least 1 GA lesion must be at least in part within a 1500 μm radius ringcentered on the fovea
The foveal center point must not be involved in any atrophic lesion
Lesion(s) must reside completely within the FAF image
Best corrected visual acuity (BCVA) score of ≥50 letters in the study eye using theearly treatment diabetic retinopathy study (ETDRS) chart (approximately equivalentto ≥20/100 on the Snellen chart).
Hyperautofluorescence of any pattern, as assessed by the CRC, must be present in thejunctional zone of GA in the study eye.
Age ≥50 years.
Men must be willing and able to use contraception (condom, abstinence) to preventpregnancy and/or exposure of an existing embryo or fetus to the investigationalproduct. A female participant is eligible if she is not a woman of childbearingpotential.
Signed informed consent consistent with International Conference ofHarmonization-Good Clinical Practice (ICH GCP) guidelines and local legislation
Exclusion
Exclusion criteria:
Any history of, or evidence of, exudative age-related macular degeneration (eAMD) inthe study eye.
Previously received treatment for GA in the study eye within 4 months or 5half-lives, prior to baseline, whichever is longer.
Previously received an investigational medication (oral or intravitreal) for GAwithin 4 months or 5 half-lives prior to baseline, whichever is longer.
Additional eye disease in the study eye that could compromise BCVA or significantlyimpact retinal morphology:
uncontrolled glaucoma, defined as a disk-to-cup ratio >0.8 or ocularhypertension with intra ocular pressure (IOP) >24 mmHg at screening visit, oruse of >2 active IOP-lowering agents in the study eye
clinically significant diabetic retinopathy or maculopathy in the opinion ofthe investigator
history of high myopia, i.e. spherical equivalent of ≥8 diopters or axiallength ≥27.2 mm. Note: if subject had prior cataract or refractive surgery,spherical equivalent should be evaluated with pre-operative refraction. Ifaxial length measurement is not available in medical records and cannot beobtained at screening visit, assessment of high myopia can be made byinvestigator on clinical examination.
anterior segment and vitreous abnormalities that would preclude adequateobservation with SD-OCT in the opinion of the investigator
other ocular conditions at the discretion of the investigator that mightinterfere with the outcome of the trial
Significant disease or other medical conditions (as determined by medical history,examination, and clinical investigations at screening) that may, in the opinion ofthe investigator result in any of the following:
put the participant at risk because of participation in the study
influence the results of the study
cause concern regarding the participant's ability to comply with the protocolrequirements or complete the trial as scheduled (e.g. chronic alcohol or drugabuse or any other condition that, in the investigator's opinion, makes theparticipant an unreliable trial participant)
Known hypersensitivity to any of the ingredients used in the investigationalmedicinal product (IMP) formulation, or any of the medications used.
Active intraocular inflammation in the study eye.
Active infectious conjunctivitis in either eye. Further exclusion criteria apply.
Study Design
Connect with a study center
Emanuelli Research & Development Center
Arecibo, 00612
Puerto RicoSite Not Available
Emanuelli Research & Development Center
Arecibo 4562635, 00612
Puerto RicoSite Not Available
Associated Retina Consultants
Gilbert, Arizona 85297
United StatesSite Not Available
Associated Retina Consultants, Ltd.
Phoenix, Arizona 85020
United StatesActive - Recruiting
Cameron Ria, LLC
Phoenix, Arizona 85050
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
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
Cameron Ria, LLC
Phoenix 5308655, Arizona 5551752 85050
United StatesSite Not Available
Retina Macula Institute of Arizona
Scottsdale 5313457, Arizona 5551752 85255
United StatesSite Not Available
Retina-Vitreous Associates Medical Group
Beverly Hills, California 90211
United StatesSite Not Available
Global Research Management
Glendale, California 91204
United StatesSite Not Available
Retinal Consultants Medical Group, Inc
Modesto, California 95356
United StatesSite Not Available
Northern California Retina Vitreous Associates MedicalGroup, Inc.
Mountain View, California 94040
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
Retina-Vitreous Associates Medical Group
Beverly Hills 5328041, California 5332921 90211
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
Northern California Retina Vitreous Associates MedicalGroup, Inc.
Mountain View 5375480, California 5332921 94040
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
Retina Specialists of Colorado Research, LLC
Denver, Colorado 80222
United StatesSite Not Available
Retina Specialists of Colorado Research, LLC
Denver 5419384, Colorado 5417618 80222
United StatesSite Not Available
Coastal Eye Surgeons
Greenwich, Connecticut 06830
United StatesSite Not Available
Coastal Eye Surgeons
Greenwich 4835395, Connecticut 4831725 06830
United StatesSite Not Available
Vitreo Retinal Associates - Gainesville
Gainesville, Florida 32605
United StatesSite Not Available
MedEye Associates
Miami, Florida 33143
United StatesSite Not Available
Eye Associates of Pinellas
Pinellas Park, Florida 33782
United StatesSite Not Available
East Florida Eye Institute
Stuart, Florida 34994
United StatesSite Not Available
Center for Retina and Macular Disease
Winter Haven, Florida 33880
United StatesSite Not Available
Vitreo Retinal Associates - Gainesville
Gainesville 4156404, Florida 4155751 32605
United StatesSite Not Available
MedEye Associates
Miami 4164138, Florida 4155751 33143
United StatesSite Not Available
Eye Associates of Pinellas
Pinellas Park 4168630, Florida 4155751 33782
United StatesSite Not Available
East Florida Eye Institute
Stuart 4174201, Florida 4155751 34994
United StatesSite Not Available
Center for Retina and Macular Disease
Winter Haven 4178552, Florida 4155751 33880
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
Illinois Retina Associates - Oak Park
Oak Park, Illinois 60304
United StatesSite Not Available
Illinois Retina Associates - Oak Park
Oak Park 4904381, Illinois 4896861 60304
United StatesSite Not Available
Butchertown Clinical Research
Louisville, Kentucky 40206
United StatesSite Not Available
The Eye Care Institute
Louisville, Kentucky 40206
United StatesSite Not Available
The Eye Care Institute
Louisville 4299276, Kentucky 6254925 40206
United StatesSite Not Available
Cumberland Valley Retina Consultants, PC.
Hagerstown, Maryland 21740
United StatesSite Not Available
Cumberland Valley Retina Consultants
Hagerstown 4357141, Maryland 4361885 21740
United StatesSite Not Available
Cumberland Valley Retina Consultants, PC.
Hagerstown 4357141, Maryland 4361885 21740
United StatesActive - Recruiting
Ophthalmic Consultants of Boston
Boston, Massachusetts 02114
United StatesSite Not Available
Ophthalmic Consultants of Boston
Boston 4930956, Massachusetts 6254926 02114
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
NJRetina
Teaneck, New Jersey 07666
United StatesSite Not Available
NJRetina
Teaneck 5105262, New Jersey 5101760 07666
United StatesSite Not Available
Verum Research, LLC
Eugene, Oregon 97401
United StatesSite Not Available
EyeHealth Northwest
Portland, Oregon 97225
United StatesSite Not Available
Retina Northwest
Portland, Oregon 97221
United StatesActive - Recruiting
Verum Research, LLC
Eugene 5725846, Oregon 5744337 97401
United StatesSite Not Available
EyeHealth Northwest
Portland 5746545, Oregon 5744337 97225
United StatesSite Not Available
Retina Northwest
Portland 5746545, Oregon 5744337 97221
United StatesSite Not Available
Mid Atlantic Retina
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Mid Atlantic Retina
Philadelphia 4560349, Pennsylvania 6254927 19107
United StatesSite Not Available
Charleston Neuroscience Institute - Charleston
Charleston, South Carolina 29414
United StatesSite Not Available
Charleston Neuroscience Institute - Charleston
Charleston 4574324, South Carolina 4597040 29414
United StatesSite Not Available
Tennessee Retina
Nashville, Tennessee 37203
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 Foundation of the Southwest
Dallas, Texas 75231
United StatesSite Not Available
Red River Research Partners, LLC
Plano, Texas 75024
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 StatesSite Not Available
Retina Consultants of Texas-The Woodlands-67575
The Woodlands, Texas 77384
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 Foundation of the Southwest
Dallas 4684888, Texas 4736286 75231
United StatesSite Not Available
Red River Research Partners, LLC
Plano 4719457, Texas 4736286 75024
United StatesSite Not Available
Red River Research Partners, LLC - Plano
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
Emerson Clinical Research Institute
Falls Church, Virginia 22042
United StatesSite Not Available
Piedmont Eye Center
Lynchburg, Virginia 24502
United StatesSite Not Available
Emerson Clinical Research Institute
Falls Church 4758390, Virginia 6254928 22042
United StatesSite Not Available
Piedmont Eye Center
Lynchburg 4771075, Virginia 6254928 24502
United StatesSite Not Available
Pacific Northwest Retina
Bellevue, Washington 98004
United StatesSite Not Available
Pacific Northwest Retina
Bellevue 5786882, Washington 5815135 98004
United StatesSite Not Available

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