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

NCT06769048 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 1484-0005U1111-1309-9115
• Study Type: interventional
• Target: 150
• Locations: 2 countries
• Sites: 44

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

Outcome Measures

Primary Outcomes (1)

• Slope of change from baseline in square root transformed geographic atrophy (GA) area as measured by fundus autofluorescence (FAF) over a treatment period of up to 50 weeks (expressed in mm/year) in the study eye

  mm is millimeters.

  Up to week 50.

Secondary Outcomes (7)

• Key secondary endpoint: Change from baseline in total attenuation as a percentage of the EZ at the macular area with a thickness of 0 μm up to week 50 assessed by volumetric OCT and EZ mapping in the study eye

  Up to week 50.

• Key secondary endpoint: Slope of change from baseline in square root transformed GA area as measured by OCT over a trial period of up to 50 weeks (expressed in mm/year) in the study eye

  Up to week 50.

• Occurrence of TEAES from drug administration until Week 52

  Up to week 52.

• Change from baseline in partial attenuation as a percentage of the ellipsoid zone (EZ) at the macular area with thickness <20 micrograms (μm) up to week 50 assessed by volumetric optical coherence tomography (OCT) in the study eye

  Up to week 50.

• Change from baseline in square root transformed geographic atrophy (GA) area as measured by fundus autofluorescence (FAF) at Week 50 (expressed in mm) in the study eye

  At baseline and at week 50.

Study Arms (4)

Placebo-matching BI 1584862

PLACEBO COMPARATOR

Drug: Placebo-matching BI 1584862

BI 1584862 dose 1

EXPERIMENTAL

Drug: BI 1584862

BI 1584862 dose 2

EXPERIMENTAL

Drug: BI 1584862

BI 1584862 dose 3

EXPERIMENTAL

Drug: BI 1584862

Interventions

Placebo-matching BI 1584862 DRUG

Placebo-matching BI 1584862

Placebo-matching BI 1584862

BI 1584862 DRUG

BI 1584862

BI 1584862 dose 1; BI 1584862 dose 2; BI 1584862 dose 3

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (44)

Associated Retina Consultants

Gilbert, Arizona, 85297, United States

Location

Associated Retina Consultants, Ltd.

Phoenix, Arizona, 85020, United States

Location

Cameron Ria, LLC

Phoenix, Arizona, 85050, United States

Location

Retina Macula Institute of Arizona

Scottsdale, Arizona, 85255, United States

Location

Retina-Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

Global Research Management

Glendale, California, 91204, United States

Location

Retina Associates of Southern California

Huntington Beach, California, 92647, United States

Location

Retinal Consultants Medical Group, Inc

Modesto, California, 95356, United States

Location

Northern California Retina Vitreous Associates MedicalGroup, Inc.

Mountain View, California, 94040, United States

Location

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

Retina Consultants of San Diego

Poway, California, 92064, United States

Location

Retinal Consultants Medical Group

Sacramento, California, 95825, United States

Location

Bay Area Retina Associates - Walnut Creek

Walnut Creek, California, 94598, United States

Location

Retina Specialists of Colorado Research, LLC

Denver, Colorado, 80222, United States

Location

Coastal Eye Surgeons

Greenwich, Connecticut, 06830, United States

Location

Vitreo Retinal Associates - Gainesville

Gainesville, Florida, 32605, United States

Location

MedEye Associates

Miami, Florida, 33143, United States

Location

Eye Associates of Pinellas

Pinellas Park, Florida, 33782, United States

Location

East Florida Eye Institute

Stuart, Florida, 34994, United States

Location

Center for Retina and Macular Disease

Winter Haven, Florida, 33880, United States

Location

Southeast Retina Center, PC

Augusta, Georgia, 30909, United States

Location

Illinois Retina Associates - Oak Park

Oak Park, Illinois, 60304, United States

Location

The Eye Care Institute

Louisville, Kentucky, 40206, United States

Location

Cumberland Valley Retina Consultants

Hagerstown, Maryland, 21740, United States

Location

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

University of Missouri Health System

Columbia, Missouri, 65212, United States

Location

NJRetina

Teaneck, New Jersey, 07666, United States

Location

Verum Research, LLC

Eugene, Oregon, 97401, United States

Location

Retina Northwest

Portland, Oregon, 97221, United States

Location

EyeHealth Northwest

Portland, Oregon, 97225, United States

Location

Mid Atlantic Retina

Philadelphia, Pennsylvania, 19107, United States

Location

Charleston Neuroscience Institute - Charleston

Charleston, South Carolina, 29414, United States

Location

Tennessee Retina

Nashville, Tennessee, 37203, United States

Location

Austin Clinical Research, LLC

Austin, Texas, 78750, United States

Location

Retina Consultants of Texas-Beaumont-70319

Beaumont, Texas, 77707, United States

Location

Retina Foundation of the Southwest

Dallas, Texas, 75231, United States

Location

Red River Research Partners, LLC - Plano

Plano, Texas, 75024, United States

Location

Retinal Consultants of San Antonio

San Antonio, Texas, 78240, United States

Location

Retina Consultants of Texas - Schertz

Schertz, Texas, 78154, United States

Location

Retina Consultants of Texas-The Woodlands-67575

The Woodlands, Texas, 77384, United States

Location

Emerson Clinical Research Institute

Falls Church, Virginia, 22042, United States

Location

Piedmont Eye Center

Lynchburg, Virginia, 24502, United States

Location

Pacific Northwest Retina

Bellevue, Washington, 98004, United States

Location

Emanuelli Research & Development Center

Arecibo, 00612, Puerto Rico

Location

Related Links

• Related Info

MeSH Terms

Conditions

Geographic Atrophy

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 10, 2025
• Study Start: January 31, 2025
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): February 26, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
• Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

Locations

US (43); PR (1)