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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
Placebo-matching BI 1584862
BI 1584862
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
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
mm is millimeters.
Time frame: Up to week 50.
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
EZ stands for ellipsoid zone. OCT stands for optical coherence tomography.
Time frame: Up to week 50.
Key secondary endpoint: Slope of change from baseline in square root transformed GA area as measured by OCT over a trial period of up to 50 weeks (expressed in mm/year) in the study eye
GA stands for geographic atrophy. OCT stands for optical coherence tomography. mm is millimeters.
Time frame: Up to week 50.
Occurrence of TEAES from drug administration until Week 52
Time frame: 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
Time frame: 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
Time frame: 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
ETDRS is early treatment diabetic retinopathy study.
Time frame: Up to week 50.
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
ETDRS is early treatment diabetic retinopathy study.
Time frame: At baseline and at week 50.
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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
...and 34 more locations