drugset / Trial / NCT02848313
An Open-Label, Phase 1 Clinical Study to Evaluate the Safety and Tolerability of Subcutaneous Elamipretide in Subjects With Intermediate Age-Related Macular Degeneration
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is an open-label, Phase 1 single-center study in approximately 40 subjects who have 1 eye with intermediate AMD, including a high-risk drusen without geographic atrophy (GA) subgroup and a noncentral GA subgroup. Eligible subjects will receive 40 mg of elamipretide administered as a once daily 1.0 mL subcutaneous injection for 12 weeks.
Timeline
- Start
- 2016-10-28
- Primary completion
- 2018-03-16
- Completion
- 2018-04-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Elamipretide | Peptide | 40 mg | Subcutaneous |