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

NCT02848313

Phase 1 Completed 40 enrolled Stealth BioTherapeutics Inc.
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

EvaluationDrugModalityDoseRoute
Subject Elamipretide Peptide 40 mg Subcutaneous