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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 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.

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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.

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

FieldValue
Enrollment Target 176 participants
Start Date 2019-03-27
Est. Completion 2022-04-14
Phase Phase 2

Sponsor

Stealth BioTherapeutics

23 total trials

What the Registry Record Tells You About NCT03891875

The ClinicalTrials.gov registry entry for NCT03891875 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 176 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,505-participant average among 74 other Age-related Macular Degeneration trials with a reported enrollment target (88% lower). The listed sponsor is Stealth BioTherapeutics, which has 23 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 7 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.