At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 40 enrolled
Drug / intervention
Elamipretidedrug
Likely dose
Elamipretide 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Phase 1 Clinical Study to Evaluate the Safety and Tolerability of Subcutaneous Elamipretide in Subjects With Intermediate Age-Related Macular Degeneration
In Brief
A Phase 1 clinical trial evaluating Elamipretide for Age-Related Macular Degeneration. Completed, enrolled 40 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAge-Related Macular Degeneration
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 2016
Enrollment StartOct 2016
Primary CompletionMar 2018
Study CompletionApr 2018
TodayJul 2026
First PostedJul 28, 2016
Enrollment StartOct 28, 2016
Primary CompletionMar 16, 2018
Study CompletionApr 10, 2018
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 9.9 years ago
Interventions
Elamipretidedrug
40 mg dose of elamipretide administered once daily as a 1.0mL SC injection.