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NCT02848313 · ClinicalTrials.gov registry record · Phase 1
An Open-Label, Phase 1 Clinical Study to Evaluate the Safety and Tolerability of Subcutaneous Elamipretide in Subjects With Intermediate Age-Related Macular Degeneration
A Phase 1 study of Age-related Macular Degeneration, sponsored by Stealth BioTherapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT02848313: Completed Phase 1 study of Age-related Macular Degeneration, sponsored by Stealth BioTherapeutics.
NCT02848313 is a Phase 1 study of Age-related Macular Degeneration that has completed, run by Stealth BioTherapeutics. The registered enrollment target is 40 participants, below the 1,507-participant average among 74 other Age-related Macular Degeneration trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02848313, a Phase 1 study of Age-related Macular Degeneration, has completed, sponsored by Stealth BioTherapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Change from Baseline in Mean Standard Luminance Best-corrected Visual Acuity (BCVA) at 4 meters, letters from Baseline to Day 7, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, and Week 28.
Conditions Studied
Interventions
- DRUG Elamipretide
Study Locations (1)
North Carolina
- Duke University School of Medicine / Dept. of Ophthalmology (Duke Eye Center) - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2016-10-28 |
| Est. Completion | 2018-04-10 |
| Phase | Phase 1 |
What the finished NCT02848313 record still lists
NCT02848313 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,507-participant average among 74 other Age-related Macular Degeneration trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Age-related Macular Degeneration appearing as the primary indexed condition, and to 1 intervention - of which Elamipretide is the first listed.
NCT02848313 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT02848313 about?
NCT02848313 is a clinical study titled "An Open-Label, Phase 1 Clinical Study to Evaluate the Safety and Tolerability of Subcutaneous Elamipretide in Subjects With Intermediate Age-Related Macular Degeneration". 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 ...
What is the current status of trial NCT02848313?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2016-10-28. Estimated completion is 2018-04-10.
What conditions does trial NCT02848313 study?
This clinical trial studies the following conditions: Age-related Macular Degeneration.
What interventions are being tested in trial NCT02848313?
The interventions under investigation include: Elamipretide (DRUG).
Who is sponsoring clinical trial NCT02848313?
This trial is sponsored by Stealth BioTherapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02848313 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Age-related Macular Degeneration
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02848313's enrollment target sits among peer trials
40 54th of 74 higher than 21 of 74 other Age-related Macular Degeneration trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Age-related Macular Degeneration trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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