A Study to Test How Well Different Doses of BI 754132 Are Tolerated in Patients With an Advanced Form of Age-related Macular Degeneration Called Geographic Atrophy
- Conditions
- Macular Degeneration
- Interventions
- Drug: BI 754132
- Registration Number
- NCT04002310
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 18
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description 0.3 mg BI 754132 - SRD part BI 754132 0.3 milligram (mg) BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. Single rising dose (SRD) part. 1 mg BI 754132 - SRD part BI 754132 1 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part. 3 mg BI 754132 - SRD part BI 754132 3 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part. 6 mg BI 754132 - SRD part BI 754132 6 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part. 6 mg BI 754132 - MD part BI 754132 6 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as 3 injections, each separated by 4 weeks (that is, Day 1, Day 29 and Day 57). Multiple dose.
- Primary Outcome Measures
Name Time Method SRD Part: Number of Patients With Ocular (in the Study Eye) or Systemic Dose Limiting Events (DLEs) From drug administration until end of trial, up to 100 days. 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.
MD Part: Number of Patients With Drug Related Adverse Events (AEs) From drug administration until end of trial, up to 155 days Number of patients with drug-related adverse events (AEs). Multiple dose (MD) part.
- Secondary Outcome Measures
Name Time Method SRD Part: Maximum Serum Concentration of BI 754132 After a Single Intravitreal Dose (Cmax) At Day 1, 4, 8, 15, 29, 56, 84 and Day 100. Maximum serum concentration of BI 754132 after a single intravitreal dose (Cmax). Single rising dose (SRD) part.
MD Part: Trough Levels of BI 754132 Before Third Administration (Cmin,2) Up to 57 days. 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.
MD Part: Plasma Concentration of BI 754132 4, 8 and 14 Weeks After the Third Administration At Day 85, 113 and Day 155. Plasma concentration of BI 754132 4, 8 and 14 weeks after the third administration. Multiple dose (MD) part.
SRD Part: Number of Patients With Drug-related Adverse Events (AEs) From drug administration until end of trial, up to 100 days. Number of patients with drug-related AEs. Single rising dose (SRD) part.
SRD Part: Number of Patients With Any Ocular Adverse Events (AEs) in the Study Eye From drug administration until end of trial, up to 100 days. Number of patients with any ocular adverse events in the study eye. Single rising dose (SRD) part.
SRD Part: Area Under the Concentration-time Curve of BI 754132 in Serum Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) At Day 1, 4, 8, 15, 29, 56, 84 and Day 100. 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.
SRD Part: Time From Dosing to Maximum Serum Concentration of BI 754132 (Tmax) At Day 1, 4, 8, 15, 29, 56, 84 and Day 100. Time from dosing to maximum serum concentration of BI 754132 (tmax). Single rising dose (SRD part).
MD Part: Trough Levels of BI 754132 Before Second Administration (Cmin,1) Up to 29 days. 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.
Trial Locations
- Locations (13)
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
Bristol Eye Hospital
🇬🇧Bristol, United Kingdom
Moorfields Eye Hospital
🇬🇧London, United Kingdom
Royal Victoria Infirmary
🇬🇧Newcastle upon Tyne, United Kingdom
Southampton General Hospital
🇬🇧Southampton, United Kingdom
Retina Consultants of Texas
🇺🇸Bellaire, Texas, United States
Western Carolina Retinal Associate PA
🇺🇸Asheville, North Carolina, United States
Mid Atlantic Retina
🇺🇸Philadelphia, Pennsylvania, United States
Retina Foundation of the Southwest
🇺🇸Dallas, Texas, United States
Royal Liverpool University Hospital
🇬🇧Liverpool, United Kingdom