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ACTIVE NOT RECRUITING
NCT06769048
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Placebo-matching BI 1584862

Placebo-matching BI 1584862

DRUG

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