Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03891875 · ClinicalTrials.gov registry record · Phase 2
ReCLAIM-2 Study to Evaluate Safety,Efficacy & Pharmacokinetics of Elamipretide in Subjects With AMD With Non-central GA
A Phase 2 study of Age-related Macular Degeneration, sponsored by Stealth BioTherapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 176
- Enrollment target
- 20
- Study locations
NCT03891875: Completed Phase 2 study of Age-related Macular Degeneration, sponsored by Stealth BioTherapeutics.
NCT03891875 is a Phase 2 study of Age-related Macular Degeneration that has completed, run by Stealth BioTherapeutics. The registered enrollment target is 176 participants, below the 1,505-participant average among 74 other Age-related Macular Degeneration trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03891875, a Phase 2 study of Age-related Macular Degeneration, has completed, sponsored by Stealth BioTherapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 176 participants
- Enrollment target
- 20
- Study locations
Study Summary
A randomized, double-masked, placebo-controlled study to evaluate the safety, efficacy and pharmacokinetics of elamipretide in subjects with Age-Related Macular Degeneration with non-central Geographic Atrophy.
Primary Outcome
Change in low luminance best corrected visual acuity (LL BCVA) score from Baseline to the end of treatment (EOT; Week 48) assessment measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) scale. ETDRS charts present a series of five letters of equal difficulty on each row, with standardized spacing between letters and rows; there is a total of 14 lines (70 letters), with letter size increasing further geometrically and equivalently in every line by a factor of 1.2589 (or 0.1 log u
Conditions Studied
Interventions
- COMBINATION_PRODUCT Subcutaneous elamipretide through the elamipretide delivery system
- COMBINATION_PRODUCT Subcutaneos placebo through the elamipretide delivery system
Study Locations (20)
Arizona
- Associated Retina Consultants, Ltd. - Peoria
- Retinal Research Institute, LLC - Phoenix
- Arizona Retina & Vitreous Consultants - Phoenix
- Retinal Research Institute, LLC - Phoenix
- Global Retina Institute - Scottsdale
California
- California Retina Consultants - Bakersfield
- Retina-Vitreous Associates Medical Group - Beverly Hills
- Retina Institute of California Medical Group - Palm Desert
- California Retina Consultants - Santa Barbara
- California Retina Consultants - Santa Maria
Florida
- Bascom Palmer Eye Institute - Miami
- MedEye Associates - Miami
- Bascom Palmer Eye Institute - Palm Beach Gardens
- Center for Retina and Macular Disease - Winter Haven
Maryland
- The Retina Care Center - Baltimore
- Cumberland valley retina consultants - Hagerstown
Massachusetts
- Ophthalmic Consultants of Boston - Boston
- New England Retina Consultants - Springfield
Georgia
- Southeast Retina Center, PC - Augusta
Michigan
- Specialty Eye Institute - Jackson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 176 participants |
| Start Date | 2019-03-27 |
| Est. Completion | 2022-04-14 |
| Phase | Phase 2 |
What the finished NCT03891875 record still lists
NCT03891875 is an interventional study that assigns participants to a tested intervention. The registered 176 participants enrollment target is mid-sized for trials with a published cap, below the 1,505-participant average among 74 other Age-related Macular Degeneration trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Age-related Macular Degeneration appearing as the primary indexed condition, and to 2 interventions - of which Subcutaneous elamipretide through the elamipretide delivery system is the first listed.
NCT03891875 names 20 study sites across 7 states, led by Arizona, California, Florida.
Frequently Asked Questions
What is clinical trial NCT03891875 about?
NCT03891875 is a clinical study titled "ReCLAIM-2 Study to Evaluate Safety,Efficacy & Pharmacokinetics of Elamipretide in Subjects With AMD With Non-central GA". A randomized, double-masked, placebo-controlled study to evaluate the safety, efficacy and pharmacokinetics of elamipretide in subjects with Age-Related Macular Degeneration with non-central Geographic Atrophy.
What is the current status of trial NCT03891875?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 176 participants. The study started on 2019-03-27. Estimated completion is 2022-04-14.
What conditions does trial NCT03891875 study?
This clinical trial studies the following conditions: Age-related Macular Degeneration.
What interventions are being tested in trial NCT03891875?
The interventions under investigation include: Subcutaneous elamipretide through the elamipretide delivery system (COMBINATION_PRODUCT), Subcutaneos placebo through the elamipretide delivery system (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT03891875?
This trial is sponsored by Stealth BioTherapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03891875 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Maryland. 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 NCT03891875's enrollment target sits among peer trials
176 18th of 74 higher than 57 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
-
Dark Adaptation as an Early Indicator of Response to Statin Therapy for Intermediate AMD
RECRUITING · Phase 2
-
A Masked, Placebo-controlled Study to Assess Iptacopan in Age-related Macular Degeneration
ACTIVE NOT RECRUITING · Phase 2
-
Study Evaluating Intravitreal hI-con1™ in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration
COMPLETED · Phase 2
-
A Study to Evaluate the Safety and Efficacy of RQC for AMD
COMPLETED · Phase 2
-
Retinal and Retinal Pigment Epithelium (RPE) Autoimmunity in Age-related Macular Degeneration (AMD)
COMPLETED · Phase 2
-
Triple Therapy - PDT Plus IVD and Intravitreal Ranibizumab Versus Lucentis Monotherapy to Treat Age-Related Macular Degeneration
COMPLETED · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03304821 · 176 participants · Phase 2
Granulocyte-Macrophage Stimulating Factor (GM-CSF) in Peripheral Arterial Disease
- NCT03447938 · 176 participants · NA
The Minimally Invasive Coronary Surgery Compared to STernotomy Coronary Artery Bypass Grafting Trial
- NCT03824145 · 176 participants · NA
Every Day Counts: A Lifestyle Program for Women With Metastatic Breast Cancer
- NCT04177914 · 176 participants · Phase 3
HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI