This is a study in adults with geographic atrophy, an advanced form of age-related macular degeneration. The purpose of this study is to find out how well different doses of BI 754132 are tolerated. The participants are in the study for about 4 months. During this time, they visit the study site about 10 times. Participants receive 1 injection of BI 754132 directly into one of the eyes affected by geographic atrophy. In this study, BI 754132 is given to humans for the first time. The doctors compare how well participants tolerate the different doses of BI 754132. The doctors also regularly check the general health of the participants.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
One single injection
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States
Retina Specialty Institute
Pensacola, Florida, United States
Center for Retina and Macular Disease
Winter Haven, Florida, United States
Southeast Retina Center, PC
Augusta, Georgia, United States
Western Carolina Retinal Associate PA
Asheville, North Carolina, United States
Mid Atlantic Retina
Philadelphia, Pennsylvania, United States
Retina Consultants of Texas
Bellaire, Texas, United States
Retina Foundation of the Southwest
Dallas, Texas, United States
Bristol Eye Hospital
Bristol, United Kingdom
Royal Liverpool University Hospital
Liverpool, United Kingdom
...and 3 more locations
SRD Part: Number of Patients With Ocular (in the Study Eye) or Systemic Dose Limiting Events (DLEs)
SRD part: Number of patients with ocular or systemic DLEs from drug administration. Systemic DLEs were defined as drug-related adverse events (AEs), as defined by the investigator, of moderate or severe intensity on the Common terminology criteria for adverse events (CTCAE) scale, and included diarrhea, cough, or patient-reported paraesthesia, dysgeusia, taste abnormality, taste disorder, or hyposmia. Single rising dose (SRD) part.
Time frame: From drug administration until end of trial, up to 100 days.
MD Part: Number of Patients With Drug Related Adverse Events (AEs)
Number of patients with drug-related adverse events (AEs). Multiple dose (MD) part.
Time frame: From drug administration until end of trial, up to 155 days
SRD Part: Number of Patients With Drug-related Adverse Events (AEs)
Number of patients with drug-related AEs. Single rising dose (SRD) part.
Time frame: From drug administration until end of trial, up to 100 days.
SRD Part: Number of Patients With Any Ocular Adverse Events (AEs) in the Study Eye
Number of patients with any ocular adverse events in the study eye. Single rising dose (SRD) part.
Time frame: From drug administration until end of trial, up to 100 days.
SRD Part: Maximum Serum Concentration of BI 754132 After a Single Intravitreal Dose (Cmax)
Maximum serum concentration of BI 754132 after a single intravitreal dose (Cmax). Single rising dose (SRD) part.
Time frame: At Day 1, 4, 8, 15, 29, 56, 84 and Day 100.
SRD Part: Area Under the Concentration-time Curve of BI 754132 in Serum Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Area under the concentration-time curve of BI 754132 in serum over the time interval from 0 extrapolated to infinity (AUC0-∞). Singe rising dose (SRD) part.
Time frame: At Day 1, 4, 8, 15, 29, 56, 84 and Day 100.
SRD Part: Time From Dosing to Maximum Serum Concentration of BI 754132 (Tmax)
Time from dosing to maximum serum concentration of BI 754132 (tmax). Single rising dose (SRD part).
Time frame: At Day 1, 4, 8, 15, 29, 56, 84 and Day 100.
MD Part: Trough Levels of BI 754132 Before Second Administration (Cmin,1)
Systematic exposure of BI 754132 after multiple intravitreal doses as assessed by Cmin,1 (trough levels of BI 754132 before second administration). Multiple dose (MD) part.
Time frame: Up to 29 days.
MD Part: Trough Levels of BI 754132 Before Third Administration (Cmin,2)
Systematic exposure of BI 754132 after multiple intravitreal doses as assessed by Cmin,2 (trough levels of BI 754132 before third administration). Multiple dose (MD) part.
Time frame: Up to 57 days.
MD Part: Plasma Concentration of BI 754132 4, 8 and 14 Weeks After the Third Administration
Plasma concentration of BI 754132 4, 8 and 14 weeks after the third administration. Multiple dose (MD) part.
Time frame: At Day 85, 113 and Day 155.
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