A Study to Test Different Doses of BI 1584862 in People With a Distinct Form of Age-related Macular Degeneration (AMD) Called Geographic Atrophy
- Conditions
- Geographic Atrophy
- Interventions
- Drug: Placebo-matching BI 1584862
- Registration Number
- NCT06769048
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This study is open to adults aged 55 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) 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 138
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo-matching BI 1584862 Placebo-matching BI 1584862 - BI 1584862 dose 1 BI 1584862 - BI 1584862 dose 2 BI 1584862 - BI 1584862 dose 3 BI 1584862 -
- Primary Outcome Measures
Name Time Method 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 Up to week 50. mm is millimeters.
- Secondary Outcome Measures
Name Time Method Key secondary endpoint: Change from baseline in total attenuation as a percentage of the EZ at the macular area with a thickness of 0 μm up to week 50 assessed by volumetric OCT and EZ mapping in the study eye Up to week 50. EZ stands for ellipsoid zone. OCT stands for optical coherence tomography.
Key secondary endpoint: Slope of change from baseline in square root transformed cRORA (GA) area as measured by OCT over a trial period of up to 50 weeks (expressed in mm/year) in the study eye Up to week 50. cRORA stands for complete retinal pigment epithelial and outer retinal atrophy. GA stands for geographic atrophy. OCT stands for optical coherence tomography. mm is millimeters.
Occurrence of TEAES from drug administration until Week 52 Up to week 52. Change from baseline in partial attenuation as a percentage of the ellipsoid zone (EZ) at the macular area with thickness <20 micrograms (μm) up to week 50 assessed by volumetric optical coherence tomography (OCT) in the study eye Up to week 50. Change from baseline in square root transformed geographic atrophy (GA) area as measured by fundus autofluorescence (FAF) at Week 50 (expressed in mm) in the study eye At baseline and at week 50. Occurrence of BCVA letter loss of ≥15 from baseline in the study eye as measured by standardized ETDRS chart for at least 2 consecutive visits between baseline and up to Week 50 Up to week 50. ETDRS is early treatment diabetic retinopathy study.
Change from baseline in best-corrected low luminance visual deficit (LLVD) score as measured in letters by ETDRS chart under low-luminance conditions at Week 50 in the study eye At baseline and at week 50. ETDRS is early treatment diabetic retinopathy study.
Related Research Topics
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Trial Locations
- Locations (24)
Eye Research Foundation
🇺🇸Newport Beach, California, United States
East Florida Eye Institute
🇺🇸Stuart, Florida, United States
Southeast Retina Center, PC
🇺🇸Augusta, Georgia, United States
Associated Retina Consultants, Ltd.
🇺🇸Phoenix, Arizona, United States
Retina Macula Institute of Arizona
🇺🇸Scottsdale, Arizona, United States
Global Research Management
🇺🇸Glendale, California, United States
Retinal Consultants Medical Group, Inc
🇺🇸Modesto, 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
Illinois Retina Associates - Oak Park
🇺🇸Oak Park, Illinois, United States
Ophthalmic Consultants of Boston
🇺🇸Boston, Massachusetts, United States
University of Missouri Health System
🇺🇸Columbia, Missouri, United States
Verum Research, LLC
🇺🇸Eugene, Oregon, United States
Retina 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
Red River Research Partners, LLC
🇺🇸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