Active — Not RecruitingPhase 2

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

United States150 participantsStarted 2025-01-31

Plain-language 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.

Who can participate

Age range50 Years

SexALL

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Inclusion criteria: * 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 Exclusion criteria: * Any history of, or evidence of, exudative age-related …

What they're measuring

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

Timeframe: Up to week 50.

Trial details

NCT IDNCT06769048

SponsorBoehringer Ingelheim

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-02-15

View on ClinicalTrials.gov More Geographic Atrophy trials