NCT06769048

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

JADE: Phase II Trial in Patients With Geographic Atrophy: A Randomized, Double-masked, Placebo-controlled, Dose-finding Study to Evaluate the Efficacy and Safety of BI 1584862

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Geographic Atrophy

Interventions

Type	Name	Description
DRUG	Placebo-matching BI 1584862	Placebo-matching BI 1584862
DRUG	BI 1584862	BI 1584862

Timeline

• Start date: 2025-01-31
• Primary completion: 2027-02-15
• Completion: 2027-02-26
• First posted: 2025-01-10
• Last updated: 2026-02-18

Locations

44 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study