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: April 29, 2025
Sponsor: Boehringer Ingelheim
Overall Status: Active - Recruiting

Phase

2

Condition

Geographic Atrophy

Treatment

Placebo-matching BI 1584862

BI 1584862

Clinical Study ID

NCT06769048
1484-0005
U1111-1309-9115
  • Ages > 55
  • All Genders

Study Summary

This study is open to adults aged 55 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) 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 ≥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

Total Participants: 138
Treatment Group(s): 2
Primary Treatment: Placebo-matching BI 1584862
Phase: 2
Study Start date:
January 31, 2025
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Associated Retina Consultants, Ltd.

    Phoenix, Arizona 85020
    United States

    Active - Recruiting

  • Retina Macula Institute of Arizona

    Scottsdale, Arizona 85255
    United States

    Active - Recruiting

  • Global Research Management

    Glendale, California 91204
    United States

    Site Not Available

  • Retinal Consultants Medical Group, Inc

    Modesto, California 95356
    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

  • Bay Area Retina Associates - Walnut Creek

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Illinois Retina Associates - Oak Park

    Oak Park, Illinois 60304
    United States

    Site Not Available

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • University of Missouri Health System

    Columbia, Missouri 65212
    United States

    Site Not Available

  • Verum Research, LLC

    Eugene, Oregon 97401
    United States

    Active - Recruiting

  • Retina Northwest

    Portland, Oregon 97221
    United States

    Site Not Available

  • Mid Atlantic Retina

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Charleston Neuroscience Institute - Charleston

    Charleston, South Carolina 29414
    United States

    Site Not Available

  • Tennessee Retina

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Austin Clinical Research, LLC

    Austin, Texas 78750
    United States

    Active - Recruiting

  • Red River Research Partners, LLC

    Plano, Texas 75024
    United States

    Site Not Available

  • Retinal Consultants of San Antonio

    San Antonio, Texas 78240
    United States

    Active - Recruiting

  • 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

  • Emerson Clinical Research Institute

    Falls Church, Virginia 22042
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.