drugset / Trial / NCT03861234
A Study to Test Different Doses of BI 836880 in Patients With an Eye Disease Called Wet Age-related Macular Degeneration (wAMD)
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2019-06-27
- Primary completion
- 2023-11-01
- Completion
- 2023-11-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BI 836880 | Protein / enzyme biologic | 0.06 mg | Intravitreal |
| Subject | BI 836880 | Protein / enzyme biologic | 0.18 mg | Intravitreal |
| Subject | BI 836880 | Protein / enzyme biologic | 0.5 mg | Intravitreal |
| Subject | BI 836880 | Protein / enzyme biologic | 1 mg | Intravitreal |
| Subject | BI 836880 | Protein / enzyme biologic | 2 mg | Intravitreal |