Trial · NCT03891875

ReCLAIM-2 Study to Evaluate Safety,Efficacy & Pharmacokinetics of Elamipretide in Subjects With AMD With Non-central GA

NCT03891875, Phase 2, Completed, Stealth BioTherapeutics Inc.; results first posted 2023-10-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. ReCLAIM-2 Study to Evaluate Safety,Efficacy & Pharmacokinetics of Elamipretide in Subjects With AMD With Non-central GA. Trials, record NCT03891875. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03891875

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: ReCLAIM-2 Study to Evaluate Safety,Efficacy & Pharmacokinetics of Elamipretide in Subjects With AMD With Non-central GA
NCT number: NCT03891875
Status: Completed
Phases: Phase 2
Enrollment: 176 participants, actual
Lead sponsor: Stealth BioTherapeutics Inc.
Conditions: Age-related Macular Degeneration
Interventions: Subcutaneous elamipretide through the elamipretide delivery system, Subcutaneos placebo through the elamipretide delivery system
First posted: 2019-03-27
Last updated: 2024-07-12
Results first posted: 2023-10-17

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	LL BCVA Score Change From Baseline	Baseline and Weeks 4, 8, 12, 24, 36, 48	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 unit), moving up the chart. Minimum score of zero, maximum score of 100. Change from baseline: a more negative score is worse outcome, a more positive score is better outcome. A lower score means less letters were read correctly (worse outcome) and a higher score means more letters were read correctly (better outcome).
Primary	GA Area Change From Baseline by OCT	Baseline and Weeks 12, 24, 36, 48	Geographic atrophy (GA) area: change from baseline as measured by optical coherence tomography (OCT) from Baseline to the end of treatment (EOT; Week 48)
Secondary	LL RA Change From Baseline	Baseline and Weeks 4,12, 36, 48	Low-luminance ready acuity (LL RA) score change from baseline to the EOT (Week 48). Mean Critical Print Size with Low Luminance in Weeks 4, 12, 36, 48 as measured by the Logarithm of the Minimum Angle of Resolution LogMAR chart. Scores range from -0.3 to 1.0, where higher number means worse acuity/worse outcome, a lower number means better acuity/better outcome.
Secondary	BCVA Change From Baseline	Baseline and Weeks 4, 8, 12, 24, 36, 48	Best-corrected visual acuity (BCVA) change from Baseline Change in best corrected visual acuity (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 unit), moving up the chart. Minimum score of zero, maximum score of 100. Change from baseline: a more negative score is worse outcome, a more positive score is better outcome. A lower score means less letters were read correctly (worse outcome) and a higher score means more letters were read correctly (better outcome).
Secondary	GA Area as Measured by Fundus Autofluorescence (FAF) Change From Baseline	Baseline and Weeks 12, 24, 36, 48	Change from Baseline in Mean Area of Geographic Atrophy (GA) by Fundus Autofluorescence (FAF) at Week 24. Fluorescein angiography (FA) was used to examine the circulation of the retina and choroid using fluorescein dye and a specialized camera to trace the dye. Fundus autofluorescence imaging of the retinal pigment epithelium and neurosensory retina was performed within 14 days of Day 0 and at every visit with the exception of Day 0 and Day 7. Atrophy is characterized by loss of the retinal pigment epithelium (RPE), overlying photoreceptors and underlying choriocapillaris. Greater area affected means a worse outcome than smaller area affected.
Other	Macular Percentage of Ellipsoid Zone (EZ) Total Attenuation From Baseline	Baseline, Week 24 and Week 48	Change from Baseline in Macular Percentage of EZ Total Attenuation by OCT: Week 24 and Week 48 measures photoreceptor loss marked by EZ degradation. Lower increase in percentage means a better outcome. Higher increase in percentage means a worse outcome.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	LL BCVA Score Change From Baseline	Baseline and Weeks 4, 8, 12, 24, 36, 48	All subjects for which LL BCVA score change from Baseline was measured. All subjects were randomized and received at least one dose of study drug and have baseline and at least one post-baseline value for LL BCVA or GA Area on OCT. There was early study discontinuation for some of the participants and row numbers, including Week 4, reflect this.	Letters	MEAN
PRIMARY	GA Area Change From Baseline by OCT	Baseline and Weeks 12, 24, 36, 48	All subjects for which GA Area Change From Baseline by OCT was measured. All subjects were randomized and received at least one dose of study drug and have baseline and at least one post-baseline value for LL BCVA or GA Area on OCT. There was early study discontinuation for some of the participants and row numbers, including Week 12, reflect this.	mm^2	MEAN
SECONDARY	LL RA Change From Baseline	Baseline and Weeks 4,12, 36, 48	All subjects for which LL RA change from baseline was measured. There was early study discontinuation for some of the participants and row numbers, including Week 4, reflect this.	units on a scale	MEAN
SECONDARY	BCVA Change From Baseline	Baseline and Weeks 4, 8, 12, 24, 36, 48	All subjects for which BCVA change from baseline was measured. There was early study discontinuation for some of the participants and row numbers, including Week 4, reflect this.	Letters	MEAN
SECONDARY	GA Area as Measured by Fundus Autofluorescence (FAF) Change From Baseline	Baseline and Weeks 12, 24, 36, 48	All subjects for which GA area as measured by fundus autofluorescence (FAF) change from baseline was measured. There was early study discontinuation for some of the participants and row numbers, including Week 12, reflect this.	mm^2	MEAN
OTHER_PRE_SPECIFIED	Macular Percentage of Ellipsoid Zone (EZ) Total Attenuation From Baseline	Baseline, Week 24 and Week 48	All subjects for which Macular Percentage of Ellipsoid Zone (EZ) Total Attenuation was measured. There was early study discontinuation for some of the participants and row numbers, including Week 24, reflect this.	percentage of EZ total attentuation	MEAN

Source ClinicalTrials.gov

Results by group52

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
LL BCVA Score Change From Baseline	Elamipretide	Week 4	0.7	Standard Deviation 6.11	Letters
LL BCVA Score Change From Baseline	Placebo	Week 4	-0.6	Standard Deviation 5.93	Letters
LL BCVA Score Change From Baseline	Elamipretide	Week 8	1.1	Standard Deviation 5.64	Letters
LL BCVA Score Change From Baseline	Placebo	Week 8	-0.8	Standard Deviation 7.71	Letters
LL BCVA Score Change From Baseline	Elamipretide	Week 12	-0.7	Standard Deviation 9.35	Letters
LL BCVA Score Change From Baseline	Placebo	Week 12	-0.9	Standard Deviation 7.05	Letters
LL BCVA Score Change From Baseline	Elamipretide	Week 24	-0.9	Standard Deviation 9.05	Letters
LL BCVA Score Change From Baseline	Placebo	Week 24	-0.9	Standard Deviation 6.80	Letters
LL BCVA Score Change From Baseline	Elamipretide	Week 36	-0.6	Standard Deviation 12.21	Letters
LL BCVA Score Change From Baseline	Placebo	Week 36	-3.2	Standard Deviation 9.37	Letters

1 to 10 of 52Source ClinicalTrials.gov

See all 52 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Elamipretide	117
Overall Study	STARTED	Placebo	59
Overall Study	COMPLETED	Elamipretide	83
Overall Study	COMPLETED	Placebo	51
Overall Study	NOT COMPLETED	Elamipretide	34
Overall Study	NOT COMPLETED	Placebo	8

Source ClinicalTrials.gov

Adverse events100

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Injection Site Pruritus	General disorders	Elamipretide	46	117
other	Injection Site Pruritus	General disorders	Placebo	0	59
other	Injection Site Pain	General disorders	Elamipretide	33	117
other	Injection Site Pain	General disorders	Placebo	6	59
other	Injection Site Bruising	General disorders	Elamipretide	15	117
other	Injection Site Bruising	General disorders	Placebo	11	59
other	Injection Site Erythema	General disorders	Elamipretide	22	117
other	Injection Site Erythema	General disorders	Placebo	0	59
other	Injection Site Haemorrhage	General disorders	Elamipretide	17	117
other	Injection Site Haemorrhage	General disorders	Placebo	4	59

1 to 10 of 100Source ClinicalTrials.gov

See all 100 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Elamipretide	2	117
Total, all-cause mortality	Placebo	0	59
Total, other adverse events	Elamipretide	83	117
Total, other adverse events	Placebo	36	59
Total, serious adverse events	Elamipretide	18	117
Total, serious adverse events	Placebo	6	59

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
39605874	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Elamipretide vs Placebo: deaths from any cause	Trial comparisons
Elamipretide vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03891875

GET https://conductscience.org/api/trials/v1/NCT03891875/results?page=2

API reference For AI assistants