Active — Not RecruitingPhase 2

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

United States202 participantsStarted 2025-01-06

Plain-language 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.

Who can participate

Age range50 Years

SexALL

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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) 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…

What they're measuring

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

Timeframe: At Baseline , at Week 56

Trial details

NCT IDNCT06722157

SponsorBoehringer Ingelheim

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-10-16

View on ClinicalTrials.gov More Macular Degeneration, Age-related trials