Peptide LibraryHuman study PLS-00113
Phase 1 Clinical Trial of Elamipretide in Intermediate Age-Related Macular Degeneration and High-Risk Drusen: ReCLAIM High-Risk Drusen Study.
Version 1 · published November 7, 2026 · evidence through November 7, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.
Only the abstract was available. Essential methods may be missing, which limits what can be judged.
Reports of this study
Every publication, registration and abstract describing this one study. Participants are counted once.
- Phase 1 Clinical Trial of Elamipretide in Intermediate Age-Related Macular Degeneration and High-Risk Drusen: ReCLAIM High-Risk Drusen Study.primary · Ophthalmology science · 2021-12-22 · PMID 36246187 · DOI
Design and participants
- Design
- Single-arm trial
- Population
- Adults aged 55 years or older with intermediate age-related macular degeneration and high-risk drusen (preplanned HRD cohort)
- Conditions
- Intermediate age-related macular degeneration, High-risk drusen
- Setting
- Single-center, open-label, 24-week phase 1 clinical trial
- Planned enrollment (registry)
- Not reported
- Enrolled
- 21
- Randomized
- Not reported
- Completed follow-up
- 18
- Funding
- Not reported in the record
- Authors’ conflicts
- Not reported in the record
Intervention and comparator
What each group received. Related peptides, analogs and combinations are never treated as the compound itself.
- Elamipretide (intervention) · elamipretide · Elamipretide given by daily subcutaneous injection · subcutaneous · Daily for 24 weeks · 21 assigned
What the authors reported
As stated in the sources. This is the authors’ account, not Peptide Library’s assessment.
Adverse events and tolerability
primary outcome · safety · Throughout 24 weeks · Adverse events assessed throughout the study
- Elamipretide: narrative — All 21 participants had at least one AE, all mild (57%) or moderate (43%); no serious systemic AEs; 3 withdrew
Normal-luminance best-corrected visual acuity (BCVA)
exploratory outcome · patient-important · 24 weeks · Change from baseline in letters
- Elamipretide: change from baseline 3.6, p = 0.014 — Mean BCVA change of +3.6 letters among completers
Low-luminance best-corrected visual acuity (LLVA)
exploratory outcome · patient-important · 24 weeks · Change from baseline in letters
- Elamipretide: change from baseline 5.6, p = 0.004 — Mean LLVA change of +5.6 letters among completers
Normal-luminance binocular reading acuity (NLRA)
exploratory outcome · patient-important · 24 weeks · Change from baseline in logMAR units
- Elamipretide: change from baseline -0.11, p = 0.001 — Mean NLRA improved by -0.11 logMAR units
Low-luminance binocular reading acuity (LLRA)
exploratory outcome · patient-important · 24 weeks · Change from baseline in logMAR units
- Elamipretide: change from baseline -0.28 — Mean LLRA improved by -0.28 logMAR units; p-value garbled in abstract
Low-luminance questionnaire (LLQ)
exploratory outcome · patient-important · 24 weeks · Change from baseline in LLQ results
- No results reported.
RPE-drusen complex volume by OCT
exploratory outcome · surrogate · 24 weeks · Change from baseline on spectral-domain OCT
- Elamipretide: narrative — No significant change observed
Fundus autofluorescence
exploratory outcome · surrogate · 24 weeks · Change from baseline in FAF
- Elamipretide: narrative — No significant change observed
Mesopic microperimetry
exploratory outcome · surrogate · 24 weeks · Change from baseline in retinal sensitivity
- Elamipretide: narrative — No significant change observed
Dark adaptation
exploratory outcome · surrogate · 24 weeks · Change from baseline in dark adaptation testing
- Elamipretide: narrative — No significant change observed
Adverse events
- Any adverse event (mild or moderate) · Elamipretide: 21 participants
- Injection site reactions (most common AE) · Elamipretide: Not reported participants
- Injection site reaction leading to discontinuation · Elamipretide: 1 participants
- Transient visual impairment leading to withdrawal · Elamipretide: 1 participants
- Serious systemic adverse events (serious) · Elamipretide: 0 participants
Monitoring: Safety and tolerability assessed throughout the 24-week study as the primary end point
The authors concluded (paraphrased): Elamipretide appeared generally safe and well tolerated in intermediate AMD with high-risk drusen. Exploratory analyses suggested better visual function, especially under low luminance, and further study is warranted.
Peptide Library’s assessment
An automated assessment, made by AI separately from the authors’ conclusions and not reviewed by a person. How risk of bias is assessed.
Limitations
- no control group: Single open-label arm with no placebo, so the visual function changes cannot be separated from learning or natural variation.
- small or imprecise: Only 21 participants treated and 18 analyzed for efficacy; no confidence intervals are reported.
- inadequate blinding: Open-label design with effort-dependent visual acuity and reading tests, which raises the risk of performance and detection bias.
- incomplete follow up: Three of 21 participants withdrew and efficacy is reported only among the 18 completers.
- selective reporting: Many exploratory endpoints were tested; only some were significant, and the LLQ result is garbled in the abstract.
- short follow up: A 24-week duration is short for a chronic progressive disease such as AMD.
- abstract only: Only the abstract is available; funding, conflicts and detailed methods are not in the record.
- inappropriate endpoint: Visual function endpoints were exploratory and unadjusted for multiplicity; the primary endpoint was safety.
Adverse events and tolerability: Serious concern (Structured limitations appraisal)
For uncontrolled studies, case series and case reports, where no validated comparative tool applies. It lists limitations; it is not a risk-of-bias rating.
| Control group | Serious concern | No placebo or comparator arm, so AE attribution to elamipretide versus background cannot be assessed. |
|---|---|---|
| Selection of participants | Not reported | Recruitment and eligibility screening details are not given beyond age and AMD/HRD criteria in the abstract. |
| Confounding | Some concern | Without a comparator, concurrent conditions or treatments could contribute to the reported AEs. |
| Follow-up and attrition | Some concern | Three of 21 withdrew, but AE data appear reported for all 21 treated participants. |
| Outcome measurement | Some concern | Open-label AE ascertainment; the method of AE collection is not detailed in the abstract. |
| Completeness of reporting | Some concern | Only aggregate severity percentages are given; counts of specific AE types are not reported. |
| Precision | Serious concern | With only 21 participants, rare or serious adverse events cannot be reliably excluded. |
| Funding and conflicts of interest | Not reported | Funding and author conflicts are not reported in the abstract record. |
Uncontrolled small open-label study limits the safety conclusions; the worst domains are serious concern.
Version 1 · published November 7, 2026 · evidence through November 7, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Peptide Library structured appraisal pl-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.
Normal-luminance best-corrected visual acuity (BCVA): Serious concern (Structured limitations appraisal)
For uncontrolled studies, case series and case reports, where no validated comparative tool applies. It lists limitations; it is not a risk-of-bias rating.
| Control group | Serious concern | Change from baseline in a single arm with no control for learning effects or regression to the mean. |
|---|---|---|
| Selection of participants | Not reported | Recruitment process is not described; single-center cohort selection is unclear. |
| Confounding | Serious concern | Repeated testing and expectation effects in the open-label setting may explain the improvement. |
| Follow-up and attrition | Some concern | The completer-only analysis (18 of 21) excludes withdrawals, including one with visual impairment. |
| Outcome measurement | Serious concern | Effort-dependent letter acuity was measured unmasked in an open-label trial. |
| Completeness of reporting | Some concern | One of many exploratory endpoints, with no correction for multiplicity mentioned. |
| Precision | Serious concern | Only 18 analyzed and no confidence interval is reported for the mean change. |
| Funding and conflicts of interest | Not reported | Funding and conflicts are not reported in the abstract. |
Uncontrolled, unmasked exploratory functional outcome with a completer analysis; serious concern.
Version 1 · published November 7, 2026 · evidence through November 7, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Peptide Library structured appraisal pl-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.
Low-luminance best-corrected visual acuity (LLVA): Serious concern (Structured limitations appraisal)
For uncontrolled studies, case series and case reports, where no validated comparative tool applies. It lists limitations; it is not a risk-of-bias rating.
| Control group | Serious concern | Single arm with no comparator for change from baseline in low-luminance acuity. |
|---|---|---|
| Selection of participants | Not reported | Recruitment and screening methods are not described in the abstract. |
| Confounding | Serious concern | Practice effects on repeated low-luminance testing are uncontrolled without a comparison group. |
| Follow-up and attrition | Some concern | Only the 18 completers of 21 treated participants were analyzed. |
| Outcome measurement | Serious concern | Unmasked, effort-dependent acuity testing in an open-label design. |
| Completeness of reporting | Some concern | Multiple exploratory endpoints were tested without a stated multiplicity adjustment. |
| Precision | Serious concern | Small sample of 18 and no confidence interval reported. |
| Funding and conflicts of interest | Not reported | Funding and conflicts are not reported in the abstract. |
No control, unmasked assessment and a small completer analysis give serious concern.
Version 1 · published November 7, 2026 · evidence through November 7, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Peptide Library structured appraisal pl-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.
Normal-luminance binocular reading acuity (NLRA): Serious concern (Structured limitations appraisal)
For uncontrolled studies, case series and case reports, where no validated comparative tool applies. It lists limitations; it is not a risk-of-bias rating.
| Control group | Serious concern | Single-arm change from baseline with no control for repeated-testing effects. |
|---|---|---|
| Selection of participants | Not reported | Recruitment details are absent from the abstract record. |
| Confounding | Serious concern | Learning and expectation effects are possible in open-label reading tests. |
| Follow-up and attrition | Some concern | Analysis restricted to 18 completers out of 21 treated. |
| Outcome measurement | Serious concern | Reading acuity is effort-dependent and was assessed without masking. |
| Completeness of reporting | Some concern | One of numerous exploratory endpoints, with no multiplicity handling stated. |
| Precision | Serious concern | Small sample and no confidence interval reported for the change. |
| Funding and conflicts of interest | Not reported | Funding and conflicts are not reported in the abstract. |
Uncontrolled, unmasked exploratory outcome in a small cohort; serious concern.
Version 1 · published November 7, 2026 · evidence through November 7, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Peptide Library structured appraisal pl-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.
Low-luminance binocular reading acuity (LLRA): Serious concern (Structured limitations appraisal)
For uncontrolled studies, case series and case reports, where no validated comparative tool applies. It lists limitations; it is not a risk-of-bias rating.
| Control group | Serious concern | No comparator arm for the LLRA change from baseline. |
|---|---|---|
| Selection of participants | Not reported | Recruitment is not described in the abstract. |
| Confounding | Serious concern | Repeated-testing effects are uncontrolled in a single-arm design. |
| Follow-up and attrition | Some concern | Only completers (18 of 21) were analyzed. |
| Outcome measurement | Serious concern | Unmasked effort-dependent reading test under low luminance. |
| Completeness of reporting | Serious concern | The LLRA p-value is garbled in the abstract text, and the endpoint is one of many exploratory ones. |
| Precision | Serious concern | Small sample, no confidence interval, and no clear p-value reported. |
| Funding and conflicts of interest | Not reported | Funding and conflicts are not reported in the abstract. |
Uncontrolled, unmasked, with unclear statistical reporting; serious concern.
Version 1 · published November 7, 2026 · evidence through November 7, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Peptide Library structured appraisal pl-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.
RPE-drusen complex volume by OCT: Serious concern (Structured limitations appraisal)
For uncontrolled studies, case series and case reports, where no validated comparative tool applies. It lists limitations; it is not a risk-of-bias rating.
| Control group | Serious concern | Single arm; the natural course of drusen volume is not controlled. |
|---|---|---|
| Selection of participants | Not reported | Recruitment details are not given in the abstract. |
| Confounding | Some concern | Disease progression over 24 weeks is unaccounted for without a comparator. |
| Follow-up and attrition | Some concern | Three of 21 withdrew; the analysis appears limited to completers. |
| Outcome measurement | Some concern | OCT volume is objective, but masking of graders is not reported. |
| Completeness of reporting | Some concern | Reported only narratively as no significant change, without values. |
| Precision | Serious concern | With only 18 analyzed, the study is likely underpowered for structural change. |
| Funding and conflicts of interest | Not reported | Funding and conflicts are not reported in the abstract. |
Uncontrolled, imprecise and narratively reported surrogate outcome.
Version 1 · published November 7, 2026 · evidence through November 7, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Peptide Library structured appraisal pl-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.
Fundus autofluorescence: Serious concern (Structured limitations appraisal)
For uncontrolled studies, case series and case reports, where no validated comparative tool applies. It lists limitations; it is not a risk-of-bias rating.
| Control group | Serious concern | No comparator to judge the FAF change against the natural course. |
|---|---|---|
| Selection of participants | Not reported | Recruitment is not described in the abstract. |
| Confounding | Some concern | Background disease progression is not controlled in the single-arm design. |
| Follow-up and attrition | Some concern | Completer analysis excludes 3 of 21 participants. |
| Outcome measurement | Some concern | Grader masking for FAF images is not reported. |
| Completeness of reporting | Some concern | Only a narrative statement of no significant change is given. |
| Precision | Serious concern | Small sample with no effect estimates reported. |
| Funding and conflicts of interest | Not reported | Funding and conflicts are not reported in the abstract. |
Uncontrolled and imprecise, with narrative-only reporting.
Version 1 · published November 7, 2026 · evidence through November 7, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Peptide Library structured appraisal pl-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.
Mesopic microperimetry: Serious concern (Structured limitations appraisal)
For uncontrolled studies, case series and case reports, where no validated comparative tool applies. It lists limitations; it is not a risk-of-bias rating.
| Control group | Serious concern | Single arm with no control for test-retest learning in microperimetry. |
|---|---|---|
| Selection of participants | Not reported | Recruitment details are absent from the abstract. |
| Confounding | Serious concern | Learning effects in psychophysical testing are uncontrolled. |
| Follow-up and attrition | Some concern | Only 18 of 21 completed and appear to have been analyzed. |
| Outcome measurement | Some concern | Psychophysical test performed open-label without masking. |
| Completeness of reporting | Some concern | Reported only as no significant change, without numbers. |
| Precision | Serious concern | Small sample with no estimates or intervals. |
| Funding and conflicts of interest | Not reported | Funding and conflicts are not reported in the abstract. |
Uncontrolled small study with narrative-only reporting; serious concern.
Version 1 · published November 7, 2026 · evidence through November 7, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Peptide Library structured appraisal pl-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.
Dark adaptation: Serious concern (Structured limitations appraisal)
For uncontrolled studies, case series and case reports, where no validated comparative tool applies. It lists limitations; it is not a risk-of-bias rating.
| Control group | Serious concern | No comparator arm for the dark adaptation change from baseline. |
|---|---|---|
| Selection of participants | Not reported | Recruitment is not described in the abstract record. |
| Confounding | Serious concern | Practice effects and disease course are uncontrolled in the single arm. |
| Follow-up and attrition | Some concern | Completer analysis of 18 of 21 treated participants. |
| Outcome measurement | Some concern | Open-label psychophysical testing without masking. |
| Completeness of reporting | Some concern | Only a narrative statement of no significant change is given. |
| Precision | Serious concern | Small sample with no effect estimates reported. |
| Funding and conflicts of interest | Not reported | Funding and conflicts are not reported in the abstract. |
Uncontrolled, small and narratively reported; serious concern.
Version 1 · published November 7, 2026 · evidence through November 7, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Peptide Library structured appraisal pl-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.
Claims this study informs
- Improves function in Barth syndrome: not eligible (wrong population) for “Muscle strength, exercise capacity and fatigue”
- Improves exercise capacity in primary mitochondrial myopathy: not eligible (wrong population) for “Six-minute walk distance and fatigue”
- Is safe for human administration: eligible for “Adverse events, including injection-site reactions, and discontinuations”, indirect evidence
- Insufficient information to assess Adverse events, including injection-site reactions, and discontinuations
Where each value comes from
- adverse_events: PMID 36246187, abstract (Results sentences 2-4) · extracted by AI (automated, not verified by a person) · abstract only
- arms: PMID 36246187, abstract (Methods sentence 1) · extracted by AI (automated, not verified by a person) · abstract only
- author_conclusion: PMID 36246187, abstract (Conclusions sentences 1-3) · extracted by AI (automated, not verified by a person) · abstract only
- design: PMID 36246187, abstract (Design sentence) · extracted by AI (automated, not verified by a person) · abstract only
- limitations: PMID 36246187, abstract (Design and Results sections) · extracted by AI (automated, not verified by a person) · abstract only
- outcomes: PMID 36246187, abstract (Main outcome measures sentences 1-2) · extracted by AI (automated, not verified by a person) · abstract only
- participants: PMID 36246187, abstract (Results sentences 2 and 5) · extracted by AI (automated, not verified by a person) · abstract only
- population: PMID 36246187, abstract (Participants sentence) · extracted by AI (automated, not verified by a person) · abstract only
- results: PMID 36246187, abstract (Results sentences 5-7) · extracted by AI (automated, not verified by a person) · abstract only
Version 1 · published November 7, 2026 · evidence through November 7, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.
These assessments describe published research. Records marked automated were produced by AI under the published methodology and have not been reviewed by a person; they can contain errors. None of this is medical advice, not a statement about any product’s safety for human use, and not a regulatory approval. Peptide Library’s vendor and partner relationships play no part in them (editorial independence).