A Study to Test Different Doses of BI 1584862 in People With a Distinct Form of Age-related Macular Degeneration (AMD) Called Geographic Atrophy

Last updated: February 17, 2026
Sponsor: Boehringer Ingelheim
Overall Status: Active - Not Recruiting

Phase

2

Condition

Geographic Atrophy

Treatment

BI 1584862

Placebo-matching BI 1584862

Clinical Study ID

NCT06769048
1484-0005
U1111-1309-9115
  • Ages > 50
  • All Genders

Study Summary

This study is open to adults aged 50 years and older with geographic atrophy that was diagnosed by imaging of the retina. The purpose of this study is to find out whether a medicine called BI 1584862 improves the eyes in people with geographic atrophy and to find the most suitable dose.

This study has 4 treatment groups. Participants are put into groups randomly, which means by chance. Initially participants can join a BI 1584862 and a placebo group; then more participants are put randomly in 2 additional BI 1584862 groups and a placebo group.

Participants are in the study for 1 year. During this time, they visit the study site 13 times. At the visits, doctors check the severity of participants' eye disease and collect information on any health problems. They take detailed pictures of the back of the eye, the retina, with imaging methods called fundus autofluorescence (FAF), near-infrared reflectance (NIR), and optical coherence tomography (OCT). They measure areas of the retina that appear healthy (bright) or start to waste away (dark, atrophy). The changes over time are then compared between the treatment groups.

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

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: BI 1584862
Phase: 2
Study Start date:
January 31, 2025
Estimated Completion Date:
February 26, 2027

Connect with a study center

  • Emanuelli Research & Development Center

    Arecibo, 00612
    Puerto Rico

    Site Not Available

  • Emanuelli Research & Development Center

    Arecibo 4562635, 00612
    Puerto Rico

    Site Not Available

  • Associated Retina Consultants

    Gilbert, Arizona 85297
    United States

    Site Not Available

  • Associated Retina Consultants, Ltd.

    Phoenix, Arizona 85020
    United States

    Active - Recruiting

  • Cameron Ria, LLC

    Phoenix, Arizona 85050
    United States

    Site Not Available

  • Phoenix Retina Associates

    Phoenix, Arizona 85050
    United States

    Site Not Available

  • Retina Macula Institute of Arizona

    Scottsdale, Arizona 85255
    United States

    Site Not Available

  • Associated Retina Consultants

    Gilbert 5295903, Arizona 5551752 85297
    United States

    Site Not Available

  • Associated Retina Consultants, Ltd.

    Phoenix 5308655, Arizona 5551752 85020
    United States

    Site Not Available

  • Cameron Ria, LLC

    Phoenix 5308655, Arizona 5551752 85050
    United States

    Site Not Available

  • Retina Macula Institute of Arizona

    Scottsdale 5313457, Arizona 5551752 85255
    United States

    Site Not Available

  • Retina-Vitreous Associates Medical Group

    Beverly Hills, California 90211
    United States

    Site Not Available

  • Global Research Management

    Glendale, California 91204
    United States

    Site Not Available

  • Retinal Consultants Medical Group, Inc

    Modesto, California 95356
    United States

    Site Not Available

  • Northern California Retina Vitreous Associates MedicalGroup, Inc.

    Mountain View, California 94040
    United States

    Site Not Available

  • Eye Research Foundation

    Newport Beach, California 92663
    United States

    Site Not Available

  • Retina Consultants of San Diego

    Poway, California 92064
    United States

    Site Not Available

  • Retinal Consultants Medical Group

    Sacramento, California 95825
    United States

    Site Not Available

  • Orange County Retina

    Santa Ana, California 92705
    United States

    Site Not Available

  • Bay Area Retina Associates - Walnut Creek

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Retina-Vitreous Associates Medical Group

    Beverly Hills 5328041, California 5332921 90211
    United States

    Site Not Available

  • Global Research Management

    Glendale 5352423, California 5332921 91204
    United States

    Site Not Available

  • Retina Associates of Southern California

    Huntington Beach 5358705, California 5332921 92647
    United States

    Site Not Available

  • Retinal Consultants Medical Group, Inc

    Modesto 5373900, California 5332921 95356
    United States

    Site Not Available

  • Northern California Retina Vitreous Associates MedicalGroup, Inc.

    Mountain View 5375480, California 5332921 94040
    United States

    Site Not Available

  • Eye Research Foundation

    Newport Beach 5376890, California 5332921 92663
    United States

    Site Not Available

  • Retina Consultants of San Diego

    Poway 5384690, California 5332921 92064
    United States

    Site Not Available

  • Retinal Consultants Medical Group

    Sacramento 5389489, California 5332921 95825
    United States

    Site Not Available

  • Bay Area Retina Associates - Walnut Creek

    Walnut Creek 5406990, California 5332921 94598
    United States

    Site Not Available

  • Retina Specialists of Colorado Research, LLC

    Denver, Colorado 80222
    United States

    Site Not Available

  • Retina Specialists of Colorado Research, LLC

    Denver 5419384, Colorado 5417618 80222
    United States

    Site Not Available

  • Coastal Eye Surgeons

    Greenwich, Connecticut 06830
    United States

    Site Not Available

  • Coastal Eye Surgeons

    Greenwich 4835395, Connecticut 4831725 06830
    United States

    Site Not Available

  • Vitreo Retinal Associates - Gainesville

    Gainesville, Florida 32605
    United States

    Site Not Available

  • MedEye Associates

    Miami, Florida 33143
    United States

    Site Not Available

  • Eye Associates of Pinellas

    Pinellas Park, Florida 33782
    United States

    Site Not Available

  • East Florida Eye Institute

    Stuart, Florida 34994
    United States

    Site Not Available

  • Center for Retina and Macular Disease

    Winter Haven, Florida 33880
    United States

    Site Not Available

  • Vitreo Retinal Associates - Gainesville

    Gainesville 4156404, Florida 4155751 32605
    United States

    Site Not Available

  • MedEye Associates

    Miami 4164138, Florida 4155751 33143
    United States

    Site Not Available

  • Eye Associates of Pinellas

    Pinellas Park 4168630, Florida 4155751 33782
    United States

    Site Not Available

  • East Florida Eye Institute

    Stuart 4174201, Florida 4155751 34994
    United States

    Site Not Available

  • Center for Retina and Macular Disease

    Winter Haven 4178552, Florida 4155751 33880
    United States

    Site Not Available

  • Southeast Retina Center, PC

    Augusta, Georgia 30909
    United States

    Site Not Available

  • Southeast Retina Center, PC

    Augusta 4180531, Georgia 4197000 30909
    United States

    Site Not Available

  • Illinois Retina Associates - Oak Park

    Oak Park, Illinois 60304
    United States

    Site Not Available

  • Illinois Retina Associates - Oak Park

    Oak Park 4904381, Illinois 4896861 60304
    United States

    Site Not Available

  • Butchertown Clinical Research

    Louisville, Kentucky 40206
    United States

    Site Not Available

  • The Eye Care Institute

    Louisville, Kentucky 40206
    United States

    Site Not Available

  • The Eye Care Institute

    Louisville 4299276, Kentucky 6254925 40206
    United States

    Site Not Available

  • Cumberland Valley Retina Consultants, PC.

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • Cumberland Valley Retina Consultants

    Hagerstown 4357141, Maryland 4361885 21740
    United States

    Site Not Available

  • Cumberland Valley Retina Consultants, PC.

    Hagerstown 4357141, Maryland 4361885 21740
    United States

    Active - Recruiting

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Ophthalmic Consultants of Boston

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Site Not Available

  • University of Missouri Health System

    Columbia, Missouri 65212
    United States

    Site Not Available

  • University of Missouri Health System

    Columbia 4381982, Missouri 4398678 65212
    United States

    Site Not Available

  • NJRetina

    Teaneck, New Jersey 07666
    United States

    Site Not Available

  • NJRetina

    Teaneck 5105262, New Jersey 5101760 07666
    United States

    Site Not Available

  • Verum Research, LLC

    Eugene, Oregon 97401
    United States

    Site Not Available

  • EyeHealth Northwest

    Portland, Oregon 97225
    United States

    Site Not Available

  • Retina Northwest

    Portland, Oregon 97221
    United States

    Active - Recruiting

  • Verum Research, LLC

    Eugene 5725846, Oregon 5744337 97401
    United States

    Site Not Available

  • EyeHealth Northwest

    Portland 5746545, Oregon 5744337 97225
    United States

    Site Not Available

  • Retina Northwest

    Portland 5746545, Oregon 5744337 97221
    United States

    Site Not Available

  • Mid Atlantic Retina

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Mid Atlantic Retina

    Philadelphia 4560349, Pennsylvania 6254927 19107
    United States

    Site Not Available

  • Charleston Neuroscience Institute - Charleston

    Charleston, South Carolina 29414
    United States

    Site Not Available

  • Charleston Neuroscience Institute - Charleston

    Charleston 4574324, South Carolina 4597040 29414
    United States

    Site Not Available

  • Tennessee Retina

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Tennessee Retina

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Site Not Available

  • Austin Clinical Research, LLC

    Austin, Texas 78750
    United States

    Site Not Available

  • Retina Consultants of Texas-Beaumont-70319

    Beaumont, Texas 77707
    United States

    Site Not Available

  • Retina Foundation of the Southwest

    Dallas, Texas 75231
    United States

    Site Not Available

  • Red River Research Partners, LLC

    Plano, Texas 75024
    United States

    Site Not Available

  • Retinal Consultants of San Antonio

    San Antonio, Texas 78240
    United States

    Site Not Available

  • Retina Consultants of Texas - Schertz

    Schertz, Texas 78154
    United States

    Site Not Available

  • Retina Consultants of Texas-The Woodlands-67575

    The Woodlands, Texas 77384
    United States

    Site Not Available

  • Austin Clinical Research, LLC

    Austin 4671654, Texas 4736286 78750
    United States

    Site Not Available

  • Retina Consultants of Texas-Beaumont-70319

    Beaumont 4672989, Texas 4736286 77707
    United States

    Site Not Available

  • Retina Foundation of the Southwest

    Dallas 4684888, Texas 4736286 75231
    United States

    Site Not Available

  • Red River Research Partners, LLC

    Plano 4719457, Texas 4736286 75024
    United States

    Site Not Available

  • Red River Research Partners, LLC - Plano

    Plano 4719457, Texas 4736286 75024
    United States

    Site Not Available

  • Retinal Consultants of San Antonio

    San Antonio 4726206, Texas 4736286 78240
    United States

    Site Not Available

  • Retina Consultants of Texas - Schertz

    Schertz 4727326, Texas 4736286 78154
    United States

    Site Not Available

  • Retina Consultants of Texas-The Woodlands-67575

    The Woodlands 4736476, Texas 4736286 77384
    United States

    Site Not Available

  • Emerson Clinical Research Institute

    Falls Church, Virginia 22042
    United States

    Site Not Available

  • Piedmont Eye Center

    Lynchburg, Virginia 24502
    United States

    Site Not Available

  • Emerson Clinical Research Institute

    Falls Church 4758390, Virginia 6254928 22042
    United States

    Site Not Available

  • Piedmont Eye Center

    Lynchburg 4771075, Virginia 6254928 24502
    United States

    Site Not Available

  • Pacific Northwest Retina

    Bellevue, Washington 98004
    United States

    Site Not Available

  • Pacific Northwest Retina

    Bellevue 5786882, Washington 5815135 98004
    United States

    Site Not Available

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