This study is open to adults with geographic atrophy, an advanced form of age-related macular degeneration. People can join the study if they are at least 50 years old. The purpose of this study is to find out how well different doses of a medicine called BI 771716 are tolerated. This study has 2 parts. Part 1 of the study takes about 3 months. In this part, participants receive 1 injection of BI 771716 directly into one of the eyes affected by geographic atrophy. Part 2 of the study takes about 4 months. In this part, participants receive 2 injections of BI 771716 directly into the eye. There are 4 weeks between the first and the second injection. In this study, BI 771716 is given to humans for the first time. The doctors compare how well participants tolerate the different doses of BI 771716. The doctors also regularly check the general health of the participants.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
BI 771716
Bay Area Retina Associates - Walnut Creek
Walnut Creek, California, United States
Florida Retina Institute
Jacksonville, Florida, United States
Florida Eye Associates
Melbourne, Florida, United States
Verum Research, LLC
Eugene, Oregon, United States
Erie Retina Research, LLC
Erie, Pennsylvania, United States
Tennessee Retina
Nashville, Tennessee, United States
Austin Clinical Research, LLC
Austin, Texas, United States
Retina Consultants of Houston, PA-Houston-62050
Houston, Texas, United States
Retina Consultants of Texas-The Woodlands-67575
The Woodlands, Texas, United States
Occurrence of ocular dose limiting events (DLEs) from drug administration until Day 8
SRD part
Time frame: Up to 7 days
Occurrence of drug-related adverse events (AEs) from drug administration until end of study (EOS)
MD part
Time frame: Up to 112 days
Occurrence of any ocular adverse events (AEs) in the study eye from drug administration until EOS
SRD part
Time frame: Up to 112 days
Maximum serum concentration of BI 771716 after a single intravitreal (IVT) dose (Cmax)
SRD part
Time frame: Up to 84 days
Area under the concentration-time curve of BI 771716 in serum over the time interval from 0 extrapolated to infinity (AUC0-∞)
SRD part
Time frame: Up to 84 days
Time from dosing to maximum serum concentration of BI 771716 (tmax)
SRD part
Time frame: Up to 84 days
Trough concentration of BI 771716 in serum
MD part
Time frame: At Day 29
BI 771716 serum concentration
MD part
Time frame: At Day 57
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