NCT04002310

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

Safety, Tolerability and Pharmacokinetics of Single Rising Intravitreal Doses and Multiple Intravitreal Dosing of BI 754132 in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration (Open Label, Non-randomized, Uncontrolled).

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Macular Degeneration

Interventions

Type	Name	Description
DRUG	BI 754132	One single injection

Timeline

• Start date: 2019-07-26
• Primary completion: 2022-08-09
• Completion: 2022-08-09
• First posted: 2019-06-28
• Last updated: 2023-09-15
• Results posted: 2023-09-15

Locations

13 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study