Trials / Completed
CompletedNCT02848313
An Open-Label, Phase 1 Clinical Study to Evaluate the Safety and Tolerability of Subcutaneous Elamipretide in Subjects With Intermediate Age-Related Macular Degeneration
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Stealth BioTherapeutics Inc. · Industry
- Sex
- All
- Age
- 55 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Elamipretide | 40 mg dose of elamipretide administered once daily as a 1.0mL SC injection. |
Timeline
- Start date
- 2016-10-28
- Primary completion
- 2018-03-16
- Completion
- 2018-04-10
- First posted
- 2016-07-28
- Last updated
- 2020-10-20
- Results posted
- 2020-09-21
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02848313. Inclusion in this directory is not an endorsement.