A Study to Test Whether BI 771716 Helps People With an Advanced Form of Age-related Macular Degeneration (AMD) Called Geographic Atrophy

Last updated: April 17, 2025
Sponsor: Boehringer Ingelheim
Overall Status: Active - Recruiting

Phase

2

Condition

Macular Degeneration

Geographic Atrophy

Treatment

BI 771716

Sham comparator to BI 771716

Pegcetacoplan

Clinical Study ID

NCT06722157
1497-0002
U1111-1308-7923
  • Ages > 50
  • All Genders

Study Summary

This study is open to people 50 years or older with an eye condition called geographic atrophy. The purpose of this study is to compare a medicine called BI 771716 with a medicine called pegcetacoplan. BI 771716 is being developed to treat people with geographic atrophy. Pegcetacoplan is a medicine already used to treat people with geographic atrophy.

In this study, participants receive either BI 771716 or pegcetacoplan as injections in the eye.

Participants are in the study for a little longer than a year and visit the study site every 4 weeks. At the visits, the study doctor checks the eyes of the participants. The results are compared between the groups of participants to see whether the treatment works. The study doctor also regularly checks participants' health and takes note of any unwanted effects.

Eligibility Criteria

Inclusion

Inclusion criteria

  • Age at least 50 years old at the time of randomization visit

  • Signed and dated written informed consent in accordance with International Council on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

  • Male or female participants. Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of use is provided in the participant information.

  • Diagnosis of geographic atrophy (GA) secondary to age-related macular degeneration (AMD), where the total GA lesion area must be ≥2.5 square millimetres (mm2) and ≤17.5 mm2 as measured by Fundus autofluorescence (FAF)

  • Note: Fellow eye is not required to have GA

  • Note: subfoveal GA lesions (defined as GA lesions within 1 micron of the foveal center point) will be allowed to be enrolled until a maximum is reached of 72 subfoveal lesions in the entire trial1 (72 is 40% of the total trial population of 180 participants). No more than 72 participants with subfoveal GA lesions should be enrolled. After the maximum of 72 participants is reached, then any participants with subfoveal GA lesions should not be enrolled

  • Best Corrected Visual Acuity (BCVA) in the fellow eye must have a better BCVA compared to the study eye

  • BCVA letter score of ≥24 letters, using the early trial diabetic retinopathy study (ETDRS) chart in the study eye (equivalent to ≥20/320 on the Snellen chart) Note: If both eyes are eligible, investigator is to select the eye with worst BCVA at the baseline visit to be the study eye

  • further inclusion criteria apply

Exclusion criteria

  • GA lesions whose area cannot be accurately defined in the study eye

  • Exudative neovascular AMD (eAMD) in the study eye

-- Note: eAMD in the fellow eye will be allowed until a maximum is reached of 72 participants with fellow eye eAMD in the entire trial2 (72 is 40% of the total trial population of 180 participants). No more than 72 participants with fellow eye eAMD should be enrolled. After the maximum of 72 participants is reached, then any participants with fellow eye eAMD should be excluded

  • Previously received treatment in either eye for GA secondary to AMD within 4 months or 5 half-lives prior to screening, whichever is longer

  • Previous trial participation receiving oral medication or intravitreal trial medication in the study eye for GA secondary to AMD within 6 months or 5 half-lives prior to screening, whichever is longer

  • Previously received gene therapy or cell therapy

  • Additional eye disease as follows:

  • Any eye disease in the study eye that could compromise BCVA

  • Uncontrolled glaucoma or ocular hypertension with intraocular pressure >24 millimetre of mercury (mmHg) in study eye

  • History of high myopia >8 diopters in the study eye anterior segment and vitreous abnormalities that would preclude adequate observation with spectral domain optical coherence tomography in the study eye

  • Ocular conditions at the discretion of the investigator that might interfere with outcome of the trial in the study eye

  • Active intraocular inflammation in the study eye

  • Active infectious conjunctivitis in either eye

  • Prior vitrectomy surgery in the study eye

  • History of major intraocular surgeries including major corneal surgery. Uneventful cataract surgery, refractive surgery, oculoplastic surgery, strabismus surgery, and other extraocular surgery may be permitted if they have occurred more than 3 months prior to screening in the study eye

  • further exclusion criteria apply

Study Design

Total Participants: 180
Treatment Group(s): 3
Primary Treatment: BI 771716
Phase: 2
Study Start date:
January 06, 2025
Estimated Completion Date:
February 16, 2027

Connect with a study center

  • Emanuelli Research & Development Center

    Arecibo, 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

    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

  • Barnet Dulaney Perkins Eye Center

    Sun City, Arizona 85351
    United States

    Site Not Available

  • Global Research Management

    Glendale, California 91204
    United States

    Active - Recruiting

  • Retina Associates of Southern California

    Huntington Beach, California 92647
    United States

    Site Not Available

  • Retinal Consultants Medical Group, Inc

    Modesto, California 95356
    United States

    Site Not Available

  • Aesthetic Eye Care Institute

    Newport Beach, California 92663
    United States

    Site Not Available

  • Eye Research Foundation

    Newport Beach, California 92663
    United States

    Active - Recruiting

  • Retina Consultants of San Diego

    Poway, California 92064
    United States

    Active - Recruiting

  • Retinal Consultants Medical Group

    Sacramento, California 95825
    United States

    Active - Recruiting

  • Orange County Retina

    Santa Ana, California 92705
    United States

    Site Not Available

  • Bay Area Retina Associates - Walnut Creek

    Walnut Creek, California 94598
    United States

    Active - Recruiting

  • Colorado Retina Associates

    Lakewood, Colorado 80228
    United States

    Site Not Available

  • Connecticut Eye Consultants, PC

    Danbury, Connecticut 06810
    United States

    Site Not Available

  • Retina Group of Florida

    Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • Eye Associates of Pinellas

    Pinellas Park, Florida 33782
    United States

    Site Not Available

  • Rand Eye Institute

    Pompano Beach, Florida 33064
    United States

    Site Not Available

  • Retina Vitreous Associates of FL

    Saint Petersburg, Florida 33711
    United States

    Site Not Available

  • Retina Vitreous Associates of Florida

    Saint Petersburg, Florida 33711
    United States

    Site Not Available

  • Southeast Retina Center, PC

    Augusta, Georgia 30909
    United States

    Active - Recruiting

  • University Retina and Macula Associates

    Lemont, Illinois 60439
    United States

    Site Not Available

  • Illinois Retina Associates - Oak Park

    Oak Park, Illinois 60304
    United States

    Site Not Available

  • Butchertown Clinical Trials

    Louisville, Kentucky 40206
    United States

    Site Not Available

  • Mid Atlantic Retina Specialists

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Retina Consultants of Minnesota

    Edina, Minnesota 55435
    United States

    Active - Recruiting

  • Mississippi Retina Associates

    Madison, Mississippi 39110
    United States

    Active - Recruiting

  • University of Missouri Health System

    Columbia, Missouri 65212
    United States

    Site Not Available

  • Envision Ocular, LLC

    Bloomfield, New Jersey 07003
    United States

    Site Not Available

  • Eye Associates of New Mexico

    Albuquerque, New Mexico 87109
    United States

    Site Not Available

  • Long Island Vitreoretinal Consultants - Westbury

    Westbury, New York 11590
    United States

    Site Not Available

  • Verum Research, LLC

    Eugene, Oregon 97401
    United States

    Active - Recruiting

  • Mid Atlantic Retina - Bethlehem

    Bethlehem, Pennsylvania 18017
    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

    Active - Recruiting

  • Retina Consultants of Charleston

    Charleston, South Carolina 29414
    United States

    Site Not Available

  • Charles Retina Institute

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • Tennessee Retina

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Austin Clinical Research, LLC

    Austin, Texas 78750
    United States

    Active - Recruiting

  • Retina Consultants of Texas-Beaumont-70319

    Beaumont, Texas 77707
    United States

    Site Not Available

  • Retina Consultants of Texas-Bellaire-67493

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Retina Foundation of the Southwest

    Dallas, Texas 75231
    United States

    Active - Recruiting

  • Retina Consultants of Texas - Katy

    Katy, Texas 77494
    United States

    Site Not Available

  • Dallas Retina Center

    Plano, Texas 75024
    United States

    Site Not Available

  • Red River Research Partners, LLC

    Plano, Texas 75024
    United States

    Suspended

  • Retina Consultants of Texas-San Antonio-70189

    San Antonio, Texas 78251
    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

    Active - Recruiting

  • Retina Consultants of Texas-The Woodlands-67575

    The Woodlands, Texas 77384
    United States

    Site Not Available

  • Strategic Clinical Research Group

    Weatherford, Texas 76087
    United States

    Site Not Available

  • Retina Associates of Utah

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • Piedmont Eye Center

    Lynchburg, Virginia 24502
    United States

    Site Not Available

  • Spokane Eye Clinic

    Spokane, Washington 99204
    United States

    Site Not Available

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