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

NCT ID: NCT06769048

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 141 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-31
• Study Completion Date: 2027-02-26

Brief 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.

Conditions

Geographic Atrophy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo-matching BI 1584862

Group Type: PLACEBO_COMPARATOR

Placebo-matching BI 1584862

Intervention Type: DRUG

Placebo-matching BI 1584862

BI 1584862 dose 1

Group Type: EXPERIMENTAL

BI 1584862

Intervention Type: DRUG

BI 1584862

BI 1584862 dose 2

Group Type: EXPERIMENTAL

BI 1584862

Intervention Type: DRUG

BI 1584862

BI 1584862 dose 3

Group Type: EXPERIMENTAL

BI 1584862

Intervention Type: DRUG

BI 1584862

Interventions

Placebo-matching BI 1584862

Placebo-matching BI 1584862

Intervention Type: DRUG

BI 1584862

BI 1584862

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Men and women with at least 1 eye with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) determined by fundus autofluorescence (FAF). The total size of all GA lesions in the study eye (as determined by the independent central 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 have an area of ≥0.5 mm^2
• At least 1 GA lesion must be at least in part within a 1500 μm radius ring centered 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 the early treatment diabetic retinopathy study (ETDRS) chart (approximately equivalent to ≥20/100 on the Snellen chart).
• Hyperautofluorescence of any pattern, as assessed by the CRC, must be present in the junctional zone of GA in the study eye.
• Age ≥50 years.
• Men must be willing and able to use contraception (condom, abstinence) to prevent pregnancy and/or exposure of an existing embryo or fetus to the investigational product. A female participant is eligible if she is not a woman of childbearing potential.
• Signed informed consent consistent with International Conference of Harmonization-Good Clinical Practice (ICH GCP) guidelines and local legislation

Exclusion Criteria

• Any history of, or evidence of, exudative age-related macular degeneration (eAMD) in the study eye.
• Previously received treatment for GA in the study eye within 4 months or 5 half-lives, prior to baseline, whichever is longer.
• Previously received an investigational medication (oral or intravitreal) for GA within 4 months or 5 half-lives prior to baseline, whichever is longer.
• Additional eye disease in the study eye that could compromise BCVA or significantly impact retinal morphology:

• uncontrolled glaucoma, defined as a disk-to-cup ratio >0.8 or ocular hypertension with intra ocular pressure (IOP) >24 mmHg at screening visit, or use of >2 active IOP-lowering agents in the study eye
• clinically significant diabetic retinopathy or maculopathy in the opinion of the investigator
• history of high myopia, i.e. spherical equivalent of ≥8 diopters or axial length ≥27.2 mm. Note: if subject had prior cataract or refractive surgery, spherical equivalent should be evaluated with pre-operative refraction. If axial length measurement is not available in medical records and cannot be obtained at screening visit, assessment of high myopia can be made by investigator on clinical examination.
• anterior segment and vitreous abnormalities that would preclude adequate observation with SD-OCT in the opinion of the investigator
• other ocular conditions at the discretion of the investigator that might interfere 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 of the 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 protocol requirements or complete the trial as scheduled (e.g. chronic alcohol or drug abuse or any other condition that, in the investigator's opinion, makes the participant an unreliable trial participant)
• Known hypersensitivity to any of the ingredients used in the investigational medicinal product (IMP) formulation, or any of the medications used.
• Active intraocular inflammation in the study eye.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Associated Retina Consultants

Gilbert, Arizona, United States

Associated Retina Consultants, Ltd.

Phoenix, Arizona, United States

Cameron Ria, LLC

Phoenix, Arizona, United States

Retina Macula Institute of Arizona

Scottsdale, Arizona, United States

Retina-Vitreous Associates Medical Group

Beverly Hills, California, United States

Global Research Management

Glendale, California, United States

Retina Associates of Southern California

Huntington Beach, California, United States

Retinal Consultants Medical Group, Inc

Modesto, California, United States

Northern California Retina Vitreous Associates MedicalGroup, Inc.

Mountain View, California, United States

Eye Research Foundation

Newport Beach, California, United States

Retina Consultants of San Diego

Poway, California, United States

Retinal Consultants Medical Group

Sacramento, California, United States

Bay Area Retina Associates - Walnut Creek

Walnut Creek, California, United States

Retina Specialists of Colorado Research, LLC

Denver, Colorado, United States

Coastal Eye Surgeons

Greenwich, Connecticut, United States

Vitreo Retinal Associates - Gainesville

Gainesville, Florida, United States

MedEye Associates

Miami, Florida, United States

Eye Associates of Pinellas

Pinellas Park, Florida, United States

East Florida Eye Institute

Stuart, Florida, United States

Center for Retina and Macular Disease

Winter Haven, Florida, United States

Southeast Retina Center, PC

Augusta, Georgia, United States

Illinois Retina Associates - Oak Park

Oak Park, Illinois, United States

The Eye Care Institute

Louisville, Kentucky, United States

Cumberland Valley Retina Consultants

Hagerstown, Maryland, United States

Ophthalmic Consultants of Boston

Boston, Massachusetts, United States

University of Missouri Health System

Columbia, Missouri, United States

NJRetina

Teaneck, New Jersey, United States

Verum Research, LLC

Eugene, Oregon, United States

Retina Northwest

Portland, Oregon, United States

EyeHealth Northwest

Portland, Oregon, United States

Mid Atlantic Retina

Philadelphia, Pennsylvania, United States

Charleston Neuroscience Institute - Charleston

Charleston, South Carolina, United States

Tennessee Retina

Nashville, Tennessee, United States

Austin Clinical Research, LLC

Austin, Texas, United States

Retina Consultants of Texas-Beaumont-70319

Beaumont, Texas, United States

Retina Foundation of the Southwest

Dallas, Texas, United States

Red River Research Partners, LLC - Plano

Plano, Texas, United States

Retinal Consultants of San Antonio

San Antonio, Texas, United States

Retina Consultants of Texas - Schertz

Schertz, Texas, United States

Retina Consultants of Texas-The Woodlands-67575

The Woodlands, Texas, United States

Emerson Clinical Research Institute

Falls Church, Virginia, United States

Piedmont Eye Center

Lynchburg, Virginia, United States

Pacific Northwest Retina

Bellevue, Washington, United States

Emanuelli Research & Development Center

Arecibo, , Puerto Rico

Countries

United States; Puerto Rico

Related Links

http://www.mystudywindow.com

Related Info

Other Identifiers

U1111-1309-9115

Identifier Type: REGISTRY

Identifier Source: secondary_id

1484-0005

Identifier Type: -

Identifier Source: org_study_id