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

NCT06722157 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 1497-0002U1111-1308-7923
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 46

Brief 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.

Conditions

Macular Degeneration, Age-related; 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) in the study eye expressed in millimeter (mm)/year

  At Baseline , at Week 56

Secondary Outcomes (5)

• Change from baseline in square root transformed GA area as measured by FAF in the study eye expressed in mm

  At Baseline, at Week 56

• Change from baseline in best corrected visual acuity (BCVA) as measured by standardized early trial diabetic retinopathy study (ETDRS) chart in the study eye

  At Baseline, at Week 56

• Occurrence of BCVA letter loss of ≥15 letters as measured by standardized ETDRS chart in the study eye for at least 2 consecutive visits

  Up to Week 56

• Occurrence of exudative neovascular age-related macular degeneration (eAMD) in the study eye from first drug administration until Week 56

  Up to Week 56

• Occurrence of drug-related adverse events (AE) from first drug administration until Week 56

  Up to Week 56

Study Arms (3)

Arm A: BI 771716

EXPERIMENTAL

Drug: BI 771716

Arm B: BI 771716 and Sham comparator

EXPERIMENTAL

Drug: BI 771716; Drug: Sham comparator to BI 771716

Arm C: Pegcetacoplan

ACTIVE COMPARATOR

Drug: Pegcetacoplan

Interventions

BI 771716 DRUG

BI 771716

Arm A: BI 771716; Arm B: BI 771716 and Sham comparator

Pegcetacoplan DRUG

Pegcetacoplan

Also known as: Syfovre ®

Arm C: Pegcetacoplan

Sham comparator to BI 771716 DRUG

Sham comparator to BI 771716

Arm B: BI 771716 and Sham comparator

Eligibility Criteria

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

You may qualify if:

• 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) 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 are provided in the participant information. Male participants must be ready and able to use either a condom or abstinence as contraceptive measures
• 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)
• If multiple lesions are present in the study eye, at least 1 lesion must have an area of ≥1.25 mm²
• 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 of approximately 60% of participants with subfoveal GA lesions are enrolled. Participants with subfoveal GA lesions already in screening at the time the cap has been reached may be considered for randomization.
• Fellow eye must have sufficient visual function compared to the study eye, per the investigator's medical judgment in consultation with the patient, to support the patient's daily functioning
• BCVA letter score of ≥24 letters, using the ETDRS chart in the study eye (equivalent to ≥20/320 on the Snellen chart). Note: If both eyes meet eligibility criteria, the eye with the worse visual function per the investigator's medical judgment in consultation with the patient, will be selected as the study eye. If both eyes have similar visual function, the study eye will be selected per the investigator's medical judgment in consultation with the patient

You may not qualify if:

• 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 is allowed. However, if the fellow eye is to be considered for microperimetry and other analyses (as defined in the trial statistical analysis plan), then eAMD is not allowed in either eye.
• Previously received treatment in the study eye for GA secondary to AMD within 4 months or 5 half-lives prior to baseline, whichever is longer
• Previously received an investigational medication (oral or intravitreal) for GA secondary to AMD within 4 months or 5 half-lives prior to baseline, whichever is longer
• Currently enrolled in another investigational device or drug trial, or 30 days or 5 half-lives, whichever is longer since ending another investigational device or drug trial(s) or receiving other investigational treatment(s). Any previous use of gene therapy or cell therapy is not permitted
• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (46)

Associated Retina Consultants

Gilbert, Arizona, 85297, United States

Location

Associated Retina Consultants, Ltd.

Phoenix, Arizona, 85020, United States

Location

Phoenix Retina Associates

Phoenix, Arizona, 85050, United States

Location

Retina Macula Institute of Arizona

Scottsdale, Arizona, 85255, 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

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

Colorado Retina Associates

Lakewood, Colorado, 80228, United States

Location

Connecticut Eye Consultants, PC

Danbury, Connecticut, 06810, United States

Location

Retina Group of New England, PC

Waterford, Connecticut, 06385, United States

Location

Rand Eye Institute

Deerfield Beach, Florida, 33064, United States

Location

Retina Group of Florida

Fort Lauderdale, Florida, 33308, United States

Location

Eye Associates of Pinellas

Pinellas Park, Florida, 33782, United States

Location

Retina Vitreous Associates of Florida

St. Petersburg, Florida, 33711, United States

Location

Southeast Retina Center, PC

Augusta, Georgia, 30909, United States

Location

University Retina and Macula Associates

Lemont, Illinois, 60439, United States

Location

Illinois Retina Associates - Oak Park

Oak Park, Illinois, 60304, United States

Location

Butchertown Clinical Trials

Louisville, Kentucky, 40206, United States

Location

Mid Atlantic Retina Specialists

Hagerstown, Maryland, 21740, United States

Location

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

Retina Consultants of Minnesota

Edina, Minnesota, 55435, United States

Location

Mississippi Retina Associates

Madison, Mississippi, 39110, United States

Location

University of Missouri Health System

Columbia, Missouri, 65212, United States

Location

Envision Ocular, LLC

Bloomfield, New Jersey, 07003, United States

Location

Eye Associates of New Mexico

Albuquerque, New Mexico, 87109, United States

Location

Long Island Vitreoretinal Consultants - Westbury

Westbury, New York, 11590, United States

Location

Verum Research, LLC

Eugene, Oregon, 97401, United States

Location

Mid Atlantic Retina - Bethlehem

Bethlehem, Pennsylvania, 18017, 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 Consultants of Texas-Bellaire-67493

Bellaire, Texas, 77401, United States

Location

Retina Foundation of the Southwest

Dallas, Texas, 75231, United States

Location

Retina Consultants of Texas - Katy

Katy, Texas, 77494, United States

Location

Red River Research Partners, LLC

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

Retina Associates of Utah

Salt Lake City, Utah, 84107, United States

Location

Piedmont Eye Center

Lynchburg, Virginia, 24502, United States

Location

Spokane Eye Clinic

Spokane, Washington, 99204, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Macular Degeneration; Geographic Atrophy

Interventions

pegcetacoplan

Condition Hierarchy (Ancestors)

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: December 5, 2024
• First Posted: December 9, 2024
• Study Start: January 6, 2025
• Primary Completion (Estimated): October 16, 2026
• Study Completion (Estimated): October 16, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

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 (46)