NCT03861234

A Study to Test Different Doses of BI 836880 in Patients With an Eye Disease Called Wet Age-related Macular Degeneration (wAMD)

Safety, Tolerability and Pharmacodynamics of Single Rising Intravitreal and Multiple Rising Intravitreal Doses of BI 836880 in Patients With wAMD (Open Label, Non-randomized, Uncontrolled).

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

This is a study in people with an eye disease called wet age-related macular degeneration (wAMD). The purpose of the study is to find out how well different doses of a medicine called BI 836880 are tolerated. People can participate if they are at least 55 years old and if they have new blood vessels in their eyes despite treatment (anti-VEGF therapies). The study has 2 parts. In the first part, people get only 1 dose of BI 836880. This part takes 6 weeks. In the second part, people get 3 times the same dose of BI 836880. This part takes 6 months. BI 836880 is injected into the eye. During the entire study doctors regularly check the health of the participants.

Conditions

• Wet Macular Degeneration

Interventions

Type	Name	Description
DRUG	BI 836880	Solution for Intravitreal (IVT) injection

Timeline

• Start date: 2019-06-27
• Primary completion: 2023-11-01
• Completion: 2023-11-01
• First posted: 2019-03-04
• Last updated: 2024-11-20
• Results posted: 2024-11-20

Locations

14 sites across 3 countries: United States, Germany, United Kingdom

Regulatory

• FDA-regulated drug study