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Study · Non-randomized trial · n = 21 · 2022

14 results

Phase 1 Clinical Trial of Elamipretide in Intermediate Age-Related Macular Degeneration and High-Risk Drusen: ReCLAIM High-Risk Drusen Study.

Allingham MJ, Mettu PS, Cousins SW

Ophthalmology science22 Dec 2021Cited by 29 (Europe PMC)

PMID36246187 (opens in a new tab)PMCIDPMC9560633 (opens in a new tab)DOI10.1016/j.xops.2021.100095 (opens in a new tab)PepBankPUB-36246187
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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 study14

14 results from studies that gave the peptide. 14 results from people.

  1. 01HumanNon-randomized trialSafety outcome

    In adults with intermediate AMD and high-risk drusen, all 21 participants had one or more adverse events, all mild (57%) or moderate (43%).

    In plain wordsIn adults with eye disease, every participant had at least one side effect, but all were mild or moderate.

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

    n = 21

    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
    57%
    high-risk drusen cohort
    moderate adverse events
    43%
    high-risk drusen cohort

    Source sentences

    Summary
    All participants with HRD (n = 21) experienced 1 or more adverse events (AEs), but all were mild (57%) or moderate (43%), with the most common events related to injection site reactions.
    2 context sentences
    Summary · context
    Adult patients ≥55 years of age with intermediate AMD and HRD.
    Summary · context
    Participants received subcutaneous elamipretide 40 mg daily, with safety and tolerability assessed throughout the study.
  2. 02HumanNon-randomized trialSafety outcome

    In adults with intermediate AMD and high-risk drusen, the most common adverse events were related to injection site reactions.

    In plain wordsIn adults with eye disease, the most common side effects were reactions at the injection site.

    Peptide
    Elamipretide (SS-31)
    Outcome
    Not applicableInjection site reactions
    Study

    n = 21

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

    Source sentences

    Summary
    All participants with HRD (n = 21) experienced 1 or more adverse events (AEs), but all were mild (57%) or moderate (43%), with the most common events related to injection site reactions.
    2 context sentences
    Summary · context
    Adult patients ≥55 years of age with intermediate AMD and HRD.
    Summary · context
    Participants received subcutaneous elamipretide 40 mg daily, with safety and tolerability assessed throughout the study.
  3. 03HumanNon-randomized trialSafety outcome

    In adults with intermediate AMD and high-risk drusen, no serious systemic adverse events occurred.

    In plain wordsIn adults with eye disease, no serious side effects affecting the whole body occurred.

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

    n = 21

    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 systemic AEs occurred.
    2 context sentences
    Summary · context
    Adult patients ≥55 years of age with intermediate AMD and HRD.
    Summary · context
    Participants received subcutaneous elamipretide 40 mg daily, with safety and tolerability assessed throughout the study.
  4. 04HumanNon-randomized trialSafety outcome

    In adults with intermediate AMD and high-risk drusen, one participant discontinued because of an injection site reaction.

    In plain wordsIn adults with eye disease, one participant stopped treatment because of a reaction at the injection site.

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

    n = 21

    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
    injection site reaction

    Source sentences

    Summary
    One participant discontinued because of injection site reaction
    2 context sentences
    Summary · context
    Adult patients ≥55 years of age with intermediate AMD and HRD.
    Summary · context
    Participants received subcutaneous elamipretide 40 mg daily, with safety and tolerability assessed throughout the study.
  5. 05HumanNon-randomized trialSafety outcome

    In adults with intermediate AMD and high-risk drusen, one participant withdrew after experiencing transient visual impairment.

    In plain wordsIn adults with eye disease, one participant left the study after short-lived vision problems.

    Peptide
    Elamipretide (SS-31)
    Outcome
    Not applicableWithdrawal after transient visual impairment
    Study

    n = 21

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

    Measurements

    participants withdrawn
    1 participants
    transient visual impairment

    Source sentences

    Summary
    1 participant withdrew after experiencing transient visual impairment.
    2 context sentences
    Summary · context
    Adult patients ≥55 years of age with intermediate AMD and HRD.
    Summary · context
    Participants received subcutaneous elamipretide 40 mg daily, with safety and tolerability assessed throughout the study.
  6. 06HumanNon-randomized trialEfficacy outcome

    In adults with intermediate AMD and high-risk drusen who completed the study, mean best-corrected visual acuity improved by 3.6 letters from baseline to 24 weeks.

    In plain wordsIn adults with eye disease who finished the study, vision on an eye chart improved by 3.6 letters after 24 weeks.

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

    n = 18

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

    Measurements

    BCVA change
    3.6 letters
    completers, week 24

    Source sentences

    Summary
    Among the 18 participants who completed the study, mean change in BCVA from baseline to 24 weeks was +3.6 letters (P = 0.014) and LLVA was +5.6 letters (P = 0.004).
    2 context sentences
    Summary · context
    Adult patients ≥55 years of age with intermediate AMD and HRD.
    Summary · context
    Participants received subcutaneous elamipretide 40 mg daily, with safety and tolerability assessed throughout the study.
  7. 07HumanNon-randomized trialEfficacy outcome

    In adults with intermediate AMD and high-risk drusen who completed the study, mean low-luminance visual acuity improved by 5.6 letters from baseline to 24 weeks.

    In plain wordsIn adults with eye disease who finished the study, vision in dim light improved by 5.6 letters after 24 weeks.

    Peptide
    Elamipretide (SS-31)
    Outcome
    IncreaseChange in LLVA at 24 weeks
    Study

    n = 18

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

    Measurements

    LLVA change
    5.6 letters
    completers, week 24

    Source sentences

    Summary
    Among the 18 participants who completed the study, mean change in BCVA from baseline to 24 weeks was +3.6 letters (P = 0.014) and LLVA was +5.6 letters (P = 0.004).
    2 context sentences
    Summary · context
    Adult patients ≥55 years of age with intermediate AMD and HRD.
    Summary · context
    Participants received subcutaneous elamipretide 40 mg daily, with safety and tolerability assessed throughout the study.
  8. 08HumanNon-randomized trialEfficacy outcome

    Normal-luminance binocular reading acuity improved by -0.11 logMAR units compared with baseline (a lower logMAR means better acuity).

    In plain wordsIn adults with eye disease, reading vision in normal light improved compared with before treatment.

    Peptide
    Elamipretide (SS-31)
    Outcome
    DecreaseChange in NLRA
    Study

    n = 18

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

    Measurements

    NLRA change
    −0.11 logMAR
    completers

    Source sentences

    Summary
    Compared with baseline, mean NLRA improved by -0.11 logarithm of the minimum angle of resolution (logMAR) units (P = 0.001), and LLRA by -0.28 logMAR units (P < 0.0001).
    2 context sentences
    Summary · context
    Adult patients ≥55 years of age with intermediate AMD and HRD.
    Summary · context
    Participants received subcutaneous elamipretide 40 mg daily, with safety and tolerability assessed throughout the study.
  9. 09HumanNon-randomized trialEfficacy outcome

    Low-luminance binocular reading acuity improved by -0.28 logMAR units compared with baseline (a lower logMAR means better acuity).

    In plain wordsIn adults with eye disease, reading vision in dim light improved compared with before treatment.

    Peptide
    Elamipretide (SS-31)
    Outcome
    DecreaseChange in LLRA
    Study

    n = 18

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

    Measurements

    LLRA change
    −0.28 logMAR
    completers

    Source sentences

    Summary
    Compared with baseline, mean NLRA improved by -0.11 logarithm of the minimum angle of resolution (logMAR) units (P = 0.001), and LLRA by -0.28 logMAR units (P < 0.0001).
    2 context sentences
    Summary · context
    Adult patients ≥55 years of age with intermediate AMD and HRD.
    Summary · context
    Participants received subcutaneous elamipretide 40 mg daily, with safety and tolerability assessed throughout the study.
  10. 10HumanNon-randomized trialEfficacy outcome

    In adults with intermediate AMD and high-risk drusen, significant improvements were found in 6 of 7 subscales of the low-luminance questionnaire.

    In plain wordsIn adults with eye disease, patients reported better vision in dim light on 6 of 7 questionnaire areas.

    Peptide
    Elamipretide (SS-31)
    Outcome
    IncreaseLow-luminance questionnaire subscales
    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
    Significant improvements were found in 6 of 7 subscales of the LLQ (P <0.0015).
    2 context sentences
    Summary · context
    Adult patients ≥55 years of age with intermediate AMD and HRD.
    Summary · context
    Participants received subcutaneous elamipretide 40 mg daily, with safety and tolerability assessed throughout the study.
  11. 11HumanNon-randomized trialEfficacy outcome

    In adults with intermediate AMD and high-risk drusen, no significant change was observed in RPE-drusen complex volume.

    In plain wordsIn adults with eye disease, the volume of drusen deposits did not change significantly.

    Peptide
    Elamipretide (SS-31)
    Outcome
    No significant changeRPE-drusen complex volume
    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
    No significant changes were observed for RPE-DC volume, FAF, mesopic microperimetry, or dark adaptation.
    2 context sentences
    Summary · context
    Adult patients ≥55 years of age with intermediate AMD and HRD.
    Summary · context
    Participants received subcutaneous elamipretide 40 mg daily, with safety and tolerability assessed throughout the study.
  12. 12HumanNon-randomized trialEfficacy outcome

    In adults with intermediate AMD and high-risk drusen, no significant change was observed in fundus autofluorescence.

    In plain wordsIn adults with eye disease, retinal autofluorescence did not change significantly.

    Peptide
    Elamipretide (SS-31)
    Outcome
    No significant changeFundus autofluorescence
    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
    No significant changes were observed for RPE-DC volume, FAF, mesopic microperimetry, or dark adaptation.
    2 context sentences
    Summary · context
    Adult patients ≥55 years of age with intermediate AMD and HRD.
    Summary · context
    Participants received subcutaneous elamipretide 40 mg daily, with safety and tolerability assessed throughout the study.
  13. 13HumanNon-randomized trialEfficacy outcome

    In adults with intermediate AMD and high-risk drusen, no significant change was observed in mesopic microperimetry.

    In plain wordsIn adults with eye disease, retinal sensitivity in low light did not change significantly.

    Peptide
    Elamipretide (SS-31)
    Outcome
    No significant changeMesopic microperimetry
    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
    No significant changes were observed for RPE-DC volume, FAF, mesopic microperimetry, or dark adaptation.
    2 context sentences
    Summary · context
    Adult patients ≥55 years of age with intermediate AMD and HRD.
    Summary · context
    Participants received subcutaneous elamipretide 40 mg daily, with safety and tolerability assessed throughout the study.
  14. 14HumanNon-randomized trialEfficacy outcome

    In adults with intermediate AMD and high-risk drusen, no significant change was observed in dark adaptation.

    In plain wordsIn adults with eye disease, the eye's adjustment to darkness did not change significantly.

    Peptide
    Elamipretide (SS-31)
    Outcome
    No significant changeDark adaptation
    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
    No significant changes were observed for RPE-DC volume, FAF, mesopic microperimetry, or dark adaptation.
    2 context sentences
    Summary · context
    Adult patients ≥55 years of age with intermediate AMD and HRD.
    Summary · context
    Participants received subcutaneous elamipretide 40 mg daily, with safety and tolerability assessed throughout the study.

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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