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Study · Non-randomized trial · n = 19 · 2022

13 results

Phase 1 Clinical Trial of Elamipretide in Dry Age-Related Macular Degeneration and Noncentral Geographic Atrophy: ReCLAIM NCGA Study.

Mettu PS, Allingham MJ, Cousins SW

Ophthalmology science27 Nov 2021Cited by 25 (Europe PMC)

PMID36246181 (opens in a new tab)PMCIDPMC9560640 (opens in a new tab)DOI10.1016/j.xops.2021.100086 (opens in a new tab)PepBankPUB-36246181
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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 study13

13 results from studies that gave the peptide. 13 results from people.

  1. 01HumanNon-randomized trialSafety outcome

    In adults with dry AMD and noncentral geographic atrophy, all 19 participants had one or more nonocular adverse events, all mild (73.7%) or moderate (26.3%).

    In plain wordsIn adults with dry age-related macular degeneration, every participant had at least one side effect outside the eye, but all were mild or moderate.

    Peptide
    Elamipretide (SS-31)
    Outcome
    Not applicableNonocular adverse events and severity
    Study

    n = 19

    Analysis
    Primary
    Outcome group
    Adverse events · Whole body
    Studied dose
    40 mg daily · subcutaneous · 24 weeksAs given in this study (human).

    Measurements

    mild adverse events
    73.7%
    NCGA cohort
    moderate adverse events
    26.3%
    NCGA cohort

    Source sentences

    Summary
    All participants (n = 19) experienced 1 or more nonocular adverse events (AEs), but all AEs were either mild (73.7%) or moderate (26.3%); no serious AEs were noted.
    2 context sentences
    Summary · context
    Adults ≥ 55 years of age with dry AMD and NCGA.
    Summary · context
    Participants received subcutaneous elamipretide 40-mg daily; safety and tolerability assessed throughout.
  2. 02HumanNon-randomized trialSafety outcome

    In adults with dry AMD and noncentral geographic atrophy, no serious adverse events were noted.

    In plain wordsIn adults with dry age-related macular degeneration, no serious side effects were noted.

    Peptide
    Elamipretide (SS-31)
    Outcome
    No significant changeSerious adverse events
    Study

    n = 19

    Analysis
    Primary
    Outcome group
    Adverse events · Whole body
    Studied dose
    40 mg daily · subcutaneous · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    no serious AEs were noted.
    2 context sentences
    Summary · context
    Adults ≥ 55 years of age with dry AMD and NCGA.
    Summary · context
    Participants received subcutaneous elamipretide 40-mg daily; safety and tolerability assessed throughout.
  3. 03HumanNon-randomized trialSafety outcome

    In adults with dry AMD and noncentral geographic atrophy, one participant exited the study because of conversion to neovascular AMD.

    In plain wordsIn adults with dry age-related macular degeneration, one participant left the study because the disease turned into the wet form.

    Peptide
    Elamipretide (SS-31)
    Outcome
    Not applicableExit due to conversion to neovascular AMD
    Study

    n = 19

    Analysis
    Primary
    Outcome group
    Adverse events · Eye
    Studied dose
    40 mg daily · subcutaneous · 24 weeksAs given in this study (human).

    Measurements

    participants exited
    1 participants
    conversion to neovascular AMD

    Source sentences

    Summary
    Two participants exited the study because of AEs (conversion to neovascular AMD, n = 1
    2 context sentences
    Summary · context
    Adults ≥ 55 years of age with dry AMD and NCGA.
    Summary · context
    Participants received subcutaneous elamipretide 40-mg daily; safety and tolerability assessed throughout.
  4. 04HumanNon-randomized trialSafety outcome

    In adults with dry AMD and noncentral geographic atrophy, one participant exited the study because of an intolerable injection site reaction.

    In plain wordsIn adults with dry age-related macular degeneration, one participant left the study because of an injection site reaction they could not tolerate.

    Peptide
    Elamipretide (SS-31)
    Outcome
    Not applicableExit due to intolerable injection site reaction
    Study

    n = 19

    Analysis
    Primary
    Outcome group
    Adverse events · Whole body
    Studied dose
    40 mg daily · subcutaneous · 24 weeksAs given in this study (human).

    Measurements

    participants exited
    1 participants
    intolerable injection site reaction

    Source sentences

    Summary
    intolerable injection site reaction, n = 1), 1 participant discontinued because of self-perceived lack of efficacy, and 1 participant chose not to continue with study visits.
    2 context sentences
    Summary · context
    Adults ≥ 55 years of age with dry AMD and NCGA.
    Summary · context
    Participants received subcutaneous elamipretide 40-mg daily; safety and tolerability assessed throughout.
  5. 05HumanNon-randomized trialSafety outcome

    In adults with dry AMD and noncentral geographic atrophy, one participant discontinued because of self-perceived lack of efficacy.

    In plain wordsIn adults with dry age-related macular degeneration, one participant stopped treatment because they felt it was not working.

    Peptide
    Elamipretide (SS-31)
    Outcome
    Not applicableDiscontinuation for self-perceived lack of efficacy
    Study

    n = 19

    Analysis
    Primary
    Outcome group
    Adverse events · Whole body
    Studied dose
    40 mg daily · subcutaneous · 24 weeksAs given in this study (human).

    Measurements

    participants discontinued
    1 participants
    self-perceived lack of efficacy

    Source sentences

    Summary
    1 participant discontinued because of self-perceived lack of efficacy, and 1 participant chose not to continue with study visits.
    2 context sentences
    Summary · context
    Adults ≥ 55 years of age with dry AMD and NCGA.
    Summary · context
    Participants received subcutaneous elamipretide 40-mg daily; safety and tolerability assessed throughout.
  6. 06HumanNon-randomized trialEfficacy outcome

    In adults with dry AMD and noncentral geographic atrophy who completed the study, mean best-corrected visual acuity improved by 4.6 letters from baseline to week 24.

    In plain wordsIn adults with dry age-related macular degeneration who finished the study, vision on an eye chart improved by 4.6 letters after 24 weeks.

    Peptide
    Elamipretide (SS-31)
    Outcome
    IncreaseChange in BCVA at week 24
    Study

    n = 15

    Analysis
    Exploratory
    Outcome group
    Vision and retina · Eye
    Studied dose
    40 mg daily · subcutaneous · 24 weeksAs given in this study (human).

    Measurements

    BCVA change
    4.6 letters
    completers, week 24

    Source sentences

    Summary
    Among participants completing the study (n = 15), mean ± standard deviation (SD) change in BCVA from baseline to week 24 was +4.6 (5.1) letters (P = 0.0032), while mean change (SD) in LLBCVA was +5.4 ± 7.9 letters (P = 0.0245).
    2 context sentences
    Summary · context
    Adults ≥ 55 years of age with dry AMD and NCGA.
    Summary · context
    Participants received subcutaneous elamipretide 40-mg daily; safety and tolerability assessed throughout.
  7. 07HumanNon-randomized trialEfficacy outcome

    In adults with dry AMD and noncentral geographic atrophy who completed the study, mean low-luminance BCVA improved by 5.4 letters from baseline to week 24.

    In plain wordsIn adults with dry age-related macular degeneration who finished the study, vision in dim light improved by 5.4 letters after 24 weeks.

    Peptide
    Elamipretide (SS-31)
    Outcome
    IncreaseChange in LLBCVA at week 24
    Study

    n = 15

    Analysis
    Exploratory
    Outcome group
    Vision and retina · Eye
    Studied dose
    40 mg daily · subcutaneous · 24 weeksAs given in this study (human).

    Measurements

    LLBCVA change
    5.4 letters
    completers, week 24

    Source sentences

    Summary
    Among participants completing the study (n = 15), mean ± standard deviation (SD) change in BCVA from baseline to week 24 was +4.6 (5.1) letters (P = 0.0032), while mean change (SD) in LLBCVA was +5.4 ± 7.9 letters (P = 0.0245).
    2 context sentences
    Summary · context
    Adults ≥ 55 years of age with dry AMD and NCGA.
    Summary · context
    Participants received subcutaneous elamipretide 40-mg daily; safety and tolerability assessed throughout.
  8. 08HumanNon-randomized trialEfficacy outcome

    In adults with dry AMD and noncentral geographic atrophy, minimal change in normal-luminance binocular reading acuity occurred.

    In plain wordsIn adults with dry age-related macular degeneration, reading vision in normal light changed very little.

    Peptide
    Elamipretide (SS-31)
    Outcome
    No significant changeChange in NLBRA
    Study

    n: not reported in source

    Analysis
    Exploratory
    Outcome group
    Vision and retina · Eye
    Studied dose
    40 mg daily · subcutaneous · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    Although minimal change in NLBRA occurred
    2 context sentences
    Summary · context
    Adults ≥ 55 years of age with dry AMD and NCGA.
    Summary · context
    Participants received subcutaneous elamipretide 40-mg daily; safety and tolerability assessed throughout.
  9. 09HumanNon-randomized trialEfficacy outcome

    In adults with dry AMD and noncentral geographic atrophy, a logMAR acuity measure (labelled LLBCVA in the abstract) changed by -0.52 units (a lower logMAR means better acuity).

    In plain wordsIn adults with dry age-related macular degeneration, an eye-chart measure in dim light improved compared with before treatment.

    Peptide
    Elamipretide (SS-31)
    Outcome
    DecreaseChange in logMAR acuity (labelled LLBCVA in abstract)
    Study

    n: not reported in source

    Analysis
    Exploratory
    Outcome group
    Vision and retina · Eye
    Studied dose
    40 mg daily · subcutaneous · 24 weeksAs given in this study (human).

    Measurements

    logMAR acuity change
    −0.52 logMAR
    week 24

    Source sentences

    Summary
    Although minimal change in NLBRA occurred, mean ± SD change in LLBCVA was -0.52 ± 0.75 logarithm of the minimum angle of resolution units (P = 0.005).
    2 context sentences
    Summary · context
    Adults ≥ 55 years of age with dry AMD and NCGA.
    Summary · context
    Participants received subcutaneous elamipretide 40-mg daily; safety and tolerability assessed throughout.
  10. 10HumanNon-randomized trialEfficacy outcome

    In adults with dry AMD and noncentral geographic atrophy, the mean change in geographic atrophy area (square root transformation) was 0.14 mm by fundus autofluorescence from baseline to week 24.

    In plain wordsIn adults with dry age-related macular degeneration, the area of retinal damage grew by about 0.14 mm on one imaging method over 24 weeks.

    Peptide
    Elamipretide (SS-31)
    Outcome
    IncreaseChange in GA area by FAF
    Study

    n: not reported in source

    Analysis
    Exploratory
    Outcome group
    Vision and retina · Eye
    Studied dose
    40 mg daily · subcutaneous · 24 weeksAs given in this study (human).

    Measurements

    GA area change (square root)
    0.14 mm
    FAF

    Source sentences

    Summary
    Mean ± SD change in GA area (square root transformation) from baseline to week 24 was 0.14 ± 0.08 mm by FAF and 0.13 ± 0.14 mm by OCT.
    2 context sentences
    Summary · context
    Adults ≥ 55 years of age with dry AMD and NCGA.
    Summary · context
    Participants received subcutaneous elamipretide 40-mg daily; safety and tolerability assessed throughout.
  11. 11HumanNon-randomized trialEfficacy outcome

    In adults with dry AMD and noncentral geographic atrophy, the mean change in geographic atrophy area (square root transformation) was 0.13 mm by OCT from baseline to week 24.

    In plain wordsIn adults with dry age-related macular degeneration, the area of retinal damage grew by about 0.13 mm on another imaging method over 24 weeks.

    Peptide
    Elamipretide (SS-31)
    Outcome
    IncreaseChange in GA area by OCT
    Study

    n: not reported in source

    Analysis
    Exploratory
    Outcome group
    Vision and retina · Eye
    Studied dose
    40 mg daily · subcutaneous · 24 weeksAs given in this study (human).

    Measurements

    GA area change (square root)
    0.13 mm
    OCT

    Source sentences

    Summary
    Mean ± SD change in GA area (square root transformation) from baseline to week 24 was 0.14 ± 0.08 mm by FAF and 0.13 ± 0.14 mm by OCT.
    2 context sentences
    Summary · context
    Adults ≥ 55 years of age with dry AMD and NCGA.
    Summary · context
    Participants received subcutaneous elamipretide 40-mg daily; safety and tolerability assessed throughout.
  12. 12HumanNon-randomized trialEfficacy outcome

    In adults with dry AMD and noncentral geographic atrophy, improvement was observed in the low-luminance questionnaire for dim light reading.

    In plain wordsIn adults with dry age-related macular degeneration, patients reported better reading in dim light.

    Peptide
    Elamipretide (SS-31)
    Outcome
    IncreaseLow-luminance questionnaire: dim light reading
    Study

    n: not reported in source

    Analysis
    Exploratory
    Outcome group
    Vision and retina · Eye
    Studied dose
    40 mg daily · subcutaneous · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    Improvement was observed in LLQ for dim light reading
    2 context sentences
    Summary · context
    Adults ≥ 55 years of age with dry AMD and NCGA.
    Summary · context
    Participants received subcutaneous elamipretide 40-mg daily; safety and tolerability assessed throughout.
  13. 13HumanNon-randomized trialEfficacy outcome

    In adults with dry AMD and noncentral geographic atrophy, improvement was observed in the low-luminance questionnaire for general dim light vision.

    In plain wordsIn adults with dry age-related macular degeneration, patients reported better general vision in dim light.

    Peptide
    Elamipretide (SS-31)
    Outcome
    IncreaseLow-luminance questionnaire: general dim light vision
    Study

    n: not reported in source

    Analysis
    Exploratory
    Outcome group
    Vision and retina · Eye
    Studied dose
    40 mg daily · subcutaneous · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    Improvement was observed in LLQ for dim light reading and general dim light vision.
    2 context sentences
    Summary · context
    Adults ≥ 55 years of age with dry AMD and NCGA.
    Summary · context
    Participants received subcutaneous elamipretide 40-mg daily; safety and tolerability assessed throughout.

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

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.

  1. Version 2Current

    10 Oct 2026, 08:19 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 02:47 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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