Phase
Condition
Geographic Atrophy
Treatment
Placebo-matching BI 1584862
BI 1584862
Clinical Study ID
Ages > 55 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 ≥1.25 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 30 or 35 degree 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 ≥55 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.
Patients who received IVT treatment for GA (pegcetacoplan or avacincaptad pegol) for ≥12 months and/or received ≥6 injections in the study eye. Patients treated for <12months who have received <6 intravitreal (IVT) injections in the study eye may beincluded after a washout period of at least 4 months between the last injection andrandomization.
Prior or ongoing investigational oral treatment for GA. A washout period of 4months, or 6 to 7 half-lives, whichever is longer, is acceptable.
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 intraocular pressure (IOP) >24 mmHg, or use of >2IOP-lowering medications in the study eye
clinically significant diabetic retinopathy or maculopathy
history of high myopia, i.e. spherical equivalent of ≥8 diopters or axiallength ≥27.2 mm
anterior segment and vitreous abnormalities that would preclude adequateobservation with Spectral domain - optical coherence tomography (SD-OCT)
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
Associated Retina Consultants, Ltd.
Phoenix, Arizona 85020
United StatesActive - Recruiting
Retina Macula Institute of Arizona
Scottsdale, Arizona 85255
United StatesActive - Recruiting
Global Research Management
Glendale, California 91204
United StatesSite Not Available
Retinal Consultants Medical Group, Inc
Modesto, California 95356
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
Bay Area Retina Associates - Walnut Creek
Walnut Creek, California 94598
United StatesSite Not Available
Illinois Retina Associates - Oak Park
Oak Park, Illinois 60304
United StatesSite Not Available
Ophthalmic Consultants of Boston
Boston, Massachusetts 02114
United StatesSite Not Available
University of Missouri Health System
Columbia, Missouri 65212
United StatesSite Not Available
Verum Research, LLC
Eugene, Oregon 97401
United StatesActive - Recruiting
Retina Northwest
Portland, Oregon 97221
United StatesSite Not Available
Mid Atlantic Retina
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Charleston Neuroscience Institute - Charleston
Charleston, South Carolina 29414
United StatesSite Not Available
Tennessee Retina
Nashville, Tennessee 37203
United StatesSite Not Available
Austin Clinical Research, LLC
Austin, Texas 78750
United StatesActive - Recruiting
Red River Research Partners, LLC
Plano, Texas 75024
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
Emerson Clinical Research Institute
Falls Church, Virginia 22042
United StatesActive - Recruiting
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