ReCLAIM-2: A Randomized Phase II Clinical Trial Evaluating Elamipretide in Age-related Macular Degeneration, Geographic Atrophy Growth, Visual Function, and Ellipsoid Zone Preservation.

Ehlers JP, Hu A, Boyer D, Cousins SW, Waheed NK, Rosenfeld PJ, Brown D, Kaiser PK, Abbruscato A, Gao G, Heier J

Ophthalmology science9 Oct 2024Cited by 27 (Europe PMC)

PMID39605874PMCIDPMC11599447DOI10.1016/j.xops.2024.100628PepBankPUB-39605874

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with dry AMD and geographic atrophy, elamipretide did not significantly change the mean low-luminance best-corrected visual acuity (primary end point) versus placebo.
In plain wordsIn people with dry AMD, elamipretide did not clearly change low-light vision compared with placebo, which missed its main goal.
Peptide
Elamipretide (SS-31)
Outcome
No significant changeChange in low-luminance best-corrected visual acuity (primary)
Study
n = 176
Comparator
Placebo
Analysis
Primary
Outcome group
Vision and retina · Eye
Studied dose
40 mg daily · subcutaneous · 48 weeksAs given in this study (human).
Source sentences
Summary
Although elamipretide did not meet statistical significance for the primary end points (mean change in LL BCVA and mean change in Sqrt converted GA area)
4 context sentences(design, population, supporting numbers)
Summary · context
ReCLAIM-2 was a prospective, phase II, randomized, placebo-controlled, double-masked, multicenter trial (NCT03891875).
Summary · context
Patients aged ≥55 years with ≥1 eye with dry AMD with GA were enrolled.
Summary · context
Administration of daily subcutaneous elamipretide 40 mg was investigated in subjects for 48 weeks followed by a 4-week follow-up period.
Summary · context
Of the 176 patients randomized, there were 117 and 59 patients in the elamipretide and placebo groups, respectively.
Report a problemFND-3960587401
02HumanRandomized controlled trialEfficacy outcome
In adults with dry AMD and geographic atrophy, elamipretide did not significantly change the mean square root converted GA area (primary end point) versus placebo.
In plain wordsIn people with dry AMD, elamipretide did not clearly change the size of the damaged retinal area compared with placebo.
Peptide
Elamipretide (SS-31)
Outcome
No significant changeChange in square root converted geographic atrophy area (primary)
Study
n = 176
Comparator
Placebo
Analysis
Primary
Outcome group
Vision and retina · Eye
Studied dose
40 mg daily · subcutaneous · 48 weeksAs given in this study (human).
Source sentences
Summary
Although elamipretide did not meet statistical significance for the primary end points (mean change in LL BCVA and mean change in Sqrt converted GA area)
4 context sentences(design, population, supporting numbers)
Summary · context
ReCLAIM-2 was a prospective, phase II, randomized, placebo-controlled, double-masked, multicenter trial (NCT03891875).
Summary · context
Patients aged ≥55 years with ≥1 eye with dry AMD with GA were enrolled.
Summary · context
Administration of daily subcutaneous elamipretide 40 mg was investigated in subjects for 48 weeks followed by a 4-week follow-up period.
Summary · context
Of the 176 patients randomized, there were 117 and 59 patients in the elamipretide and placebo groups, respectively.
Report a problemFND-3960587402
03HumanRandomized controlled trialSafety outcome
In adults with dry AMD and geographic atrophy, adverse events were reported more often with elamipretide than with placebo.
In plain wordsIn people with dry AMD, side effects were reported more often with elamipretide than with placebo.
Peptide
Elamipretide (SS-31)
Outcome
IncreaseAdverse events
Study
n = 176
Comparator
Placebo
Analysis
Primary
Outcome group
Adverse events · Whole body
Studied dose
40 mg daily · subcutaneous · 48 weeksAs given in this study (human).
Measurements
Adverse event rate
86%
elamipretide
Adverse event rate
71%
placebo
Source sentences
Summary
Adverse events were reported in 86% of those receiving elamipretide and 71% of the placebo group
4 context sentences(design, population, supporting numbers)
Summary · context
ReCLAIM-2 was a prospective, phase II, randomized, placebo-controlled, double-masked, multicenter trial (NCT03891875).
Summary · context
Patients aged ≥55 years with ≥1 eye with dry AMD with GA were enrolled.
Summary · context
Administration of daily subcutaneous elamipretide 40 mg was investigated in subjects for 48 weeks followed by a 4-week follow-up period.
Summary · context
Of the 176 patients randomized, there were 117 and 59 patients in the elamipretide and placebo groups, respectively.
Report a problemFND-3960587406
04HumanRandomized controlled trialEfficacy outcome
In adults with dry AMD and geographic atrophy, elamipretide reduced the mean progression of total ellipsoid zone loss versus placebo at week 48.
In plain wordsIn people with dry AMD, elamipretide slowed loss of a key retinal layer more than placebo at week 48.
Peptide
Elamipretide (SS-31)
Outcome
DecreaseProgression of total ellipsoid zone attenuation/loss at week 48
Study
n = 176
Comparator
Placebo
Outcome group
Vision and retina · Eye
Studied dose
40 mg daily · subcutaneous · 48 weeksAs given in this study (human).
Measurements
Reduction in progression of total EZ loss
43%
elamipretide vs placebo, week 48
Source sentences
Summary
elamipretide produced a 43% reduction in the mean progression from BL in the macular percentage of total EZ attenuation/loss (i.e., complete loss of EZ band; nominal P = 0.0034)
5 context sentences(design, population, supporting numbers)
Summary · context
versus placebo at week 48.
Summary · context
ReCLAIM-2 was a prospective, phase II, randomized, placebo-controlled, double-masked, multicenter trial (NCT03891875).
Summary · context
Patients aged ≥55 years with ≥1 eye with dry AMD with GA were enrolled.
Summary · context
Administration of daily subcutaneous elamipretide 40 mg was investigated in subjects for 48 weeks followed by a 4-week follow-up period.
Summary · context
Of the 176 patients randomized, there were 117 and 59 patients in the elamipretide and placebo groups, respectively.
Report a problemFND-3960587403
05HumanRandomized controlled trialEfficacy outcome
In adults with dry AMD and geographic atrophy, elamipretide reduced the mean progression of partial ellipsoid zone attenuation versus placebo at week 48.
In plain wordsIn people with dry AMD, elamipretide slowed partial thinning of a key retinal layer more than placebo at week 48.
Peptide
Elamipretide (SS-31)
Outcome
DecreaseProgression of partial ellipsoid zone attenuation/degradation at week 48
Study
n = 176
Comparator
Placebo
Outcome group
Vision and retina · Eye
Studied dose
40 mg daily · subcutaneous · 48 weeksAs given in this study (human).
Measurements
Reduction in progression of partial EZ attenuation
47%
elamipretide vs placebo, week 48
Source sentences
Summary
47% reduction in the mean progression of macular percentage of partial EZ attenuation/degradation (i.e., EZ-retinal pigment endothelium thickness of ≤20 microns; nominal P = 0.0040)
5 context sentences(design, population, supporting numbers)
Summary · context
versus placebo at week 48.
Summary · context
ReCLAIM-2 was a prospective, phase II, randomized, placebo-controlled, double-masked, multicenter trial (NCT03891875).
Summary · context
Patients aged ≥55 years with ≥1 eye with dry AMD with GA were enrolled.
Summary · context
Administration of daily subcutaneous elamipretide 40 mg was investigated in subjects for 48 weeks followed by a 4-week follow-up period.
Summary · context
Of the 176 patients randomized, there were 117 and 59 patients in the elamipretide and placebo groups, respectively.
Report a problemFND-3960587404
06HumanRandomized controlled trialEfficacy outcome
In adults with dry AMD and geographic atrophy, more patients on elamipretide than on placebo had a gain of at least 10 letters in LL BCVA.
In plain wordsIn people with dry AMD, more patients gained at least 10 letters of low-light vision with elamipretide than with placebo.
Peptide
Elamipretide (SS-31)
Outcome
IncreasePatients with a 10 letter or greater gain in LL BCVA
Study
n = 176
Comparator
Placebo
Outcome group
Vision and retina · Eye
Studied dose
40 mg daily · subcutaneous · 48 weeksAs given in this study (human).
Measurements
Patients with >=10 letter gain
14.6%
elamipretide
Patients with >=10 letter gain
2.1%
placebo
Source sentences
Summary
Elamipretide treatment was also associated with significantly more patients experiencing a ≥10 letter gain in LL BCVA versus placebo (14.6% vs. 2.1%; nominal P = 0.0404).
4 context sentences(design, population, supporting numbers)
Summary · context
ReCLAIM-2 was a prospective, phase II, randomized, placebo-controlled, double-masked, multicenter trial (NCT03891875).
Summary · context
Patients aged ≥55 years with ≥1 eye with dry AMD with GA were enrolled.
Summary · context
Administration of daily subcutaneous elamipretide 40 mg was investigated in subjects for 48 weeks followed by a 4-week follow-up period.
Summary · context
Of the 176 patients randomized, there were 117 and 59 patients in the elamipretide and placebo groups, respectively.
Report a problemFND-3960587405
07HumanRandomized controlled trialSafety outcome
In adults with dry AMD and geographic atrophy, injection site reactions (pruritus, pain, bruising, erythema) were the most common adverse events with elamipretide.
In plain wordsIn people with dry AMD, the most common side effects of elamipretide were reactions where the injection was given.
Peptide
Elamipretide (SS-31)
Outcome
Not applicableInjection site reactions
Study
n = 176
Outcome group
Adverse events · Skin and wound
Studied dose
40 mg daily · subcutaneous · 48 weeksAs given in this study (human).
Source sentences
Summary
with the most common events being injection site reactions (e.g., pruritus, injection site pain, bruising, and erythema).
4 context sentences(design, population, supporting numbers)
Summary · context
ReCLAIM-2 was a prospective, phase II, randomized, placebo-controlled, double-masked, multicenter trial (NCT03891875).
Summary · context
Patients aged ≥55 years with ≥1 eye with dry AMD with GA were enrolled.
Summary · context
Administration of daily subcutaneous elamipretide 40 mg was investigated in subjects for 48 weeks followed by a 4-week follow-up period.
Summary · context
Of the 176 patients randomized, there were 117 and 59 patients in the elamipretide and placebo groups, respectively.
Report a problemFND-3960587407

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 2Results postedNCT03891875

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

Stealth BioTherapeutics Inc.n = 17627 Mar 2019 to 14 Apr 2022

Age-related Macular Degeneration

Trial page ClinicalTrials.govUpdated 12 Jul 2024

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
10 Oct 2026, 08:19 UTC
Study results updated
Version 1
9 Oct 2026, 02:47 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

Publication types

Keywords

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