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A Study to Test Different Doses of BI 1584862 in People With a Distinct Form of Age-related Macular Degeneration (AMD) Called Geographic Atrophy
Sponsor: Boehringer Ingelheim
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.
Official title: 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
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2025-01-31
Completion Date
2027-02-26
Last Updated
2026-02-18
Healthy Volunteers
No
Conditions
Interventions
Placebo-matching BI 1584862
Placebo-matching BI 1584862
BI 1584862
BI 1584862
Locations (44)
Associated Retina Consultants
Gilbert, Arizona, United States
Associated Retina Consultants, Ltd.
Phoenix, Arizona, United States
Cameron Ria, LLC
Phoenix, Arizona, United States
Retina Macula Institute of Arizona
Scottsdale, Arizona, United States
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States
Global Research Management
Glendale, California, United States
Retina Associates of Southern California
Huntington Beach, California, United States
Retinal Consultants Medical Group, Inc
Modesto, California, United States
Northern California Retina Vitreous Associates MedicalGroup, Inc.
Mountain View, California, United States
Eye Research Foundation
Newport Beach, California, United States
Retina Consultants of San Diego
Poway, California, United States
Retinal Consultants Medical Group
Sacramento, California, United States
Bay Area Retina Associates - Walnut Creek
Walnut Creek, California, United States
Retina Specialists of Colorado Research, LLC
Denver, Colorado, United States
Coastal Eye Surgeons
Greenwich, Connecticut, United States
Vitreo Retinal Associates - Gainesville
Gainesville, Florida, United States
MedEye Associates
Miami, Florida, United States
Eye Associates of Pinellas
Pinellas Park, Florida, United States
East Florida Eye Institute
Stuart, Florida, United States
Center for Retina and Macular Disease
Winter Haven, Florida, United States
Southeast Retina Center, PC
Augusta, Georgia, United States
Illinois Retina Associates - Oak Park
Oak Park, Illinois, United States
The Eye Care Institute
Louisville, Kentucky, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States
University of Missouri Health System
Columbia, Missouri, United States
NJRetina
Teaneck, New Jersey, United States
Verum Research, LLC
Eugene, Oregon, United States
Retina Northwest
Portland, Oregon, United States
EyeHealth Northwest
Portland, Oregon, United States
Mid Atlantic Retina
Philadelphia, Pennsylvania, United States
Charleston Neuroscience Institute - Charleston
Charleston, South Carolina, United States
Tennessee Retina
Nashville, Tennessee, United States
Austin Clinical Research, LLC
Austin, Texas, United States
Retina Consultants of Texas-Beaumont-70319
Beaumont, Texas, United States
Retina Foundation of the Southwest
Dallas, Texas, United States
Red River Research Partners, LLC - Plano
Plano, Texas, United States
Retinal Consultants of San Antonio
San Antonio, Texas, United States
Retina Consultants of Texas - Schertz
Schertz, Texas, United States
Retina Consultants of Texas-The Woodlands-67575
The Woodlands, Texas, United States
Emerson Clinical Research Institute
Falls Church, Virginia, United States
Piedmont Eye Center
Lynchburg, Virginia, United States
Pacific Northwest Retina
Bellevue, Washington, United States
Emanuelli Research & Development Center
Arecibo, Puerto Rico