This study is open to people 50 years or older with an eye condition called geographic atrophy. The purpose of this study is to compare a medicine called BI 771716 with a medicine called pegcetacoplan. BI 771716 is being developed to treat people with geographic atrophy. Pegcetacoplan is a medicine already used to treat people with geographic atrophy. In this study, participants receive either BI 771716 or pegcetacoplan as injections in the eye. Participants are in the study for a little longer than a year and visit the study site every 4 weeks. At the visits, the study doctor checks the eyes of the participants. The results are compared between the groups of participants to see whether the treatment works. The study doctor also regularly checks participants' health and takes note of any unwanted effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
202
BI 771716
Pegcetacoplan
Sham comparator to BI 771716
Associated Retina Consultants
Gilbert, Arizona, United States
Associated Retina Consultants, Ltd.
Phoenix, Arizona, United States
Phoenix Retina Associates
Phoenix, Arizona, United States
Retina Macula Institute of Arizona
Scottsdale, Arizona, United States
Global Research Management
Glendale, California, United States
Slope of change from baseline in square root transformed geographic atrophy (GA) area as measured by fundus autofluorescence (FAF) in the study eye expressed in millimeter (mm)/year
Time frame: At Baseline , at Week 56
Change from baseline in square root transformed GA area as measured by FAF in the study eye expressed in mm
Time frame: At Baseline, at Week 56
Change from baseline in best corrected visual acuity (BCVA) as measured by standardized early trial diabetic retinopathy study (ETDRS) chart in the study eye
Time frame: At Baseline, at Week 56
Occurrence of BCVA letter loss of ≥15 letters as measured by standardized ETDRS chart in the study eye for at least 2 consecutive visits
Time frame: Up to Week 56
Occurrence of exudative neovascular age-related macular degeneration (eAMD) in the study eye from first drug administration until Week 56
Time frame: Up to Week 56
Occurrence of drug-related adverse events (AE) from first drug administration until Week 56
Time frame: Up to Week 56
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Retina Associates of Southern California
Huntington Beach, California, United States
Retinal Consultants Medical Group, Inc
Modesto, 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
...and 36 more locations