This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for ReCLAIM-2 Study to Evaluate Safety,Efficacy & Pharmacokinetics of Elamipretide in Subjects With AMD With Non-central GA (NCT03891875), a randomized phase 2 study. The primary outcome is LL BCVA Score Change From Baseline.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03891875 |
| Phase | Phase 2 |
| Condition | Age-related Macular Degeneration |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 176 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Stealth BioTherapeutics Inc. |
| Results posted | Yes |
2. Clinical Question
Population
The study enrolled subjects with age-related macular degeneration with non-central geographic atrophy. The registry reports enrollment of 176. For the primary outcome, the described population includes subjects with measured change in low-luminance best-corrected visual acuity (LL BCVA); the outcome description further specifies randomization, at least one dose of study drug, baseline data, and at least one post-baseline value for LL BCVA or geographic atrophy area on optical coherence tomography (OCT).
Intervention
The active-treatment group received a once-daily 40 mg subcutaneous injection of elamipretide using the elamipretide delivery system for 48 weeks, followed by a 4 week follow-up period. The study evaluated safety, efficacy, and pharmacokinetics; the registry record does not report pharmacokinetic results in the outcome information available for this analysis.
Comparator
The comparison group received a once-daily subcutaneous placebo injection using the same delivery system for 48 weeks, followed by a 4 week follow-up period. The study is described as randomized, double-masked, and placebo-controlled. The registry categorizes masking as quadruple, but does not identify the masked parties in the record summarized for this analysis.
Primary question
The primary outcome was change from baseline in LL BCVA score, measured in letters, with the end-of-treatment assessment at Week 48. The clinical question is whether the recorded change differs between the elamipretide and placebo groups. A more positive change represents a better score and a more negative change a worse score. The registry record does not report an analyzed comparison or treatment-effect estimate for this outcome, so its direction and magnitude cannot be assessed from the posted results.
3. Trial Design
ReCLAIM-2 was a Phase 2 randomized, parallel-group, placebo-controlled clinical study sponsored by Stealth BioTherapeutics Inc. It evaluated elamipretide in subjects with age-related macular degeneration with non-central geographic atrophy. The registry record lists enrollment of 176 and classifies the study as completed. The recorded start date is 2019-03-27, and the primary completion date is 2022-02-22.
Participants assigned to elamipretide received a once-daily 40 mg subcutaneous injection through the elamipretide delivery system for 48 weeks, followed by a 4 week follow-up period. Participants assigned to placebo received a once-daily subcutaneous placebo injection through that delivery system for the same stated treatment and follow-up periods. The registry describes the study as double-masked and categorizes masking as quadruple. The identities of the parties covered by that masking category are not reported in the registry record.
The primary outcome was change from baseline in LL BCVA score. It was scheduled for assessment at baseline and Weeks 4, 8, 12, 24, 36, and 48, with Week 48 identified as the end-of-treatment assessment. The listed secondary outcomes include change from baseline in low-luminance reading acuity, change from baseline in best-corrected visual acuity, and change from baseline in geographic atrophy area measured by fundus autofluorescence. The registry lists 6 outcome measures overall.
The record identifies randomization and a parallel design, but does not report the allocation ratio, details of sequence generation, concealment procedures, or protocol deviations. It also does not report a statistical analysis plan or a trial-specific sample-size justification. Those details should not be inferred from the design labels or enrollment count.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Elamipretide | Placebo |
|---|---|---|
| STARTED | 117 | 59 |
| COMPLETED | 83 | 51 |
| NOT COMPLETED | 34 | 8 |
Reasons for not completing this period:
| Reason | Elamipretide | Placebo |
|---|---|---|
| Withdrawal by Subject | 20 | 3 |
| Adverse Event | 10 | 4 |
| Physician Decision | 1 | 1 |
| Protocol Violation | 1 | 0 |
| Lost to Follow-up | 1 | 0 |
| COVID-19 infection | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: 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.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: All subjects that 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.
| Characteristic | Unit | Elamipretide | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 114 | 58 | 172 | |
| Age, Continuous | years | 76.0 (SD 8.40) | 75.8 (SD 8.80) | 76.0 (SD 8.51) |
| Sex: Female, Male: Female | Participants | 68 | 36 | 104 |
| Sex: Female, Male: Male | Participants | 46 | 22 | 68 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 2 | 2 | 4 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 111 | 53 | 164 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 1 | 3 | 4 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): Asian | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): White | Participants | 112 | 57 | 169 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 114 | 58 | 172 |
| Body Mass Index | kg/m^2 | 29.85 (SD 6.479) | 27.92 (SD 5.380) | 29.20 (SD 6.181) |
| GA Area (mm2) by OCT | mm^2 | 1.47 (SD 0.761) | 1.38 (SD 0.682) | 1.44 (SD 0.734) |
| LL BCVA Score | Letters | 53.4 (SD 16.17) | 58.8 (SD 10.70) | 55.2 (SD 14.75) |
| BCVA Score | Letters | 75.8 (SD 9.09) | 76.6 (SD 7.90) | 76.1 (SD 8.69) |
6. Primary Endpoint
The registry lists the primary outcome as LL BCVA Score Change From Baseline, measured over Baseline and Weeks 4, 8, 12, 24, 36, 48.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Letters |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change from baseline in LL BCVA score, measured in letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) scale. The outcome description identifies the Week 48 end-of-treatment assessment as the primary endpoint time point, while also listing assessments at baseline and Weeks 4, 8, 12, 24, and 36. The scale has a minimum score of zero and a maximum score of 100. A higher score means more letters were read correctly; for change from baseline, a more positive score indicates improvement in the measure and a more negative score indicates worsening.
Low-luminance visual acuity assesses letter reading under reduced luminance. Such a measure can be relevant to the study population because the trial concerns geographic atrophy that is not central, and the endpoint is intended to capture visual performance rather than an anatomical measurement alone. The registry describes use of the ETDRS scale, whose chart presents rows of letters with standardized spacing and difficulty.
The endpoint is continuous: each participant can have a range of change scores, and a group mean describes the average change. The spread of individual scores also matters, so the registry identifies standard deviation as the dispersion measure. The endpoint definition and measurement schedule are reported, but the registry record does not report group means, standard deviations, or a treatment-effect estimate for the primary outcome.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a clinically interpretable primary measure and a scheduled end-of-treatment assessment, but it does not report the analyzed results needed to compare elamipretide with placebo on that measure. There are no posted group-level changes, standard deviations, confidence intervals, or p-values for the primary outcome in the record summarized for this analysis. The direction, size, and precision of any treatment contrast therefore cannot be evaluated from these results.
The primary measure is change in LL BCVA letters, where a more positive change is better on the stated scale and a more negative change is worse. That orientation explains how a reported estimate would be read, but it does not indicate which group had the more favorable result. No treatment effect should be inferred from the trial’s enrollment, design, or safety counts.
The outcome was planned at several time points, including Week 48, and the registry notes that the primary outcome has several categories or time points and was not reduced to one comparison. The record lists 6 outcome measures and no analyses. Accordingly, it does not establish which time-point contrast, if any, was treated as the main inferential comparison, nor does it report the handling of repeated measurements. The endpoint description alone cannot answer whether the groups differed at Week 48 or at another assessment.
The registry does report safety counts. Serious adverse events were recorded for 18 of 117 participants at risk in the elamipretide group and 6 of 59 at risk in the placebo group. Deaths were recorded for 2 participants in the elamipretide group and 0 in the placebo group. These are descriptive counts, not a reported comparative safety analysis. The record does not provide a treatment-attributable interpretation, adjustment for differences in exposure, or an inferential comparison for these counts. They should be read as the posted event information, not as proof of cause or as a complete summary of each participant’s experience.
The presence of a randomized, masked, placebo-controlled design describes how the study was structured; it does not substitute for reporting the outcome estimates. Without the analyzed endpoint data and uncertainty measures, readers cannot judge the magnitude or precision of the primary comparison. The registry record also does not report a conclusion about efficacy, so no conclusion about treatment benefit or lack of benefit follows from the information available.
9. Statistical Methods Explained
The primary outcome is a continuous measure, and the registry identifies the mean as its summary parameter and standard deviation as its dispersion measure. In general, a mean describes the average observed value in a group, while a standard deviation describes how widely individual values vary around that average. The standard deviation is not itself an estimate of the uncertainty in the group mean; that uncertainty depends on the variability and amount of observed data. The registry does not report the mean or standard deviation for either group’s primary outcome.
What does change from baseline represent?
For each participant, change from baseline represents the follow-up score relative to the score at the starting assessment. A group mean change summarizes those participant-level changes. A comparison of mean changes between randomized groups can describe the average difference in trajectory or endpoint change, depending on the analysis used. The registry record does not report which model or estimator was used for the primary endpoint, so it is not possible to say whether the planned analysis compared Week 48 changes directly, used repeated measurements, or adjusted for baseline values in another way.
Measurement was scheduled at baseline and Weeks 4, 8, 12, 24, 36, and 48. Repeated assessments can provide information about the pattern over time, but they also require a defined analysis strategy. General approaches can account for correlations among measurements from the same participant; treating those measurements as unrelated would not reflect that repeated observations come from one person. The registry record does not report the model, covariance structure, or contrast used to handle the multiple assessments.
How should uncertainty be understood?
In general, a confidence interval gives a range of values compatible with the data and the assumptions of the analysis, and indicates the precision of an estimate. A narrow interval represents greater precision than a wide interval, while neither interval alone establishes whether an effect is clinically important. A p-value, when reported, addresses compatibility between data and a specified null hypothesis under a statistical model; it does not measure the size or importance of a treatment effect. No confidence interval or p-value for the primary comparison is reported in the registry record, so neither precision nor statistical evidence for that comparison can be assessed.
Randomization is intended to make assigned groups comparable on average with respect to characteristics measured and unmeasured at baseline. Masking can reduce the influence of expectations on care, measurement, and reporting. These design features can strengthen a treatment comparison, but they do not eliminate the need to report the analysis population, missing-data handling, outcome estimates, and uncertainty. The registry identifies randomization and masking but does not report the allocation procedure, the masked parties, or the analysis details needed to assess those aspects further.
What do the planning assumptions mean?
General sample-size planning estimates depend on assumptions about the effect to detect, variability, significance level, allocation, and the statistical method. The planning illustration associated with this study uses a two-sided significance level of 0.05, equal allocation between groups, and a normal approximation; its target effect is expressed as a fraction of an observed effect. These are assumptions for a planning illustration, not a report of the trial’s original design justification. The registry does not report the trial’s own sample-size justification or the basis for its enrollment target.
A sample-size calculation based on an observed effect is conditional on that effect and the chosen assumptions. It does not describe the probability that the completed study detected an effect, and should not be called observed power. Planning values are not outcomes and do not replace an estimate with a confidence interval. The record summarized for this analysis does not report the primary treatment-effect estimate needed to interpret such an effect-based planning exercise in clinical terms.
Why can over-dispersion matter?
In general, over-dispersion occurs when observed variability is greater than the statistical model assumes. When it is not accounted for, standard errors can be understated and confidence intervals can be too narrow. The endpoint is described as a continuous mean with standard deviation, but the registry does not report a fitted model or diagnostics that would show whether over-dispersion was considered. This general issue should not be taken as evidence that over-dispersion occurred in this study.
The registry also lists secondary outcomes, including reading acuity, best-corrected visual acuity, and geographic atrophy area measured by fundus autofluorescence. Different outcomes can have different measurement scales and distributions, so their analysis methods may differ. The record lists 6 outcome measures but no analyses, and does not report model choices or estimates for the secondary outcomes. In short, the design and outcome definitions identify what was intended to be measured, while the statistical procedures and numerical efficacy results are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The primary endpoint was scheduled at baseline and Weeks 4, 8, 12, 24, 36, and 48. The registry indicates that the primary outcome has several categories or time points and was not reduced to one comparison. Multiple assessments can create multiple opportunities to test a difference. In general, a prespecified testing strategy or multiplicity adjustment can control the chance of false-positive findings across a family of comparisons. The record does not report such a strategy, identify a single primary contrast for statistical testing, or describe any adjustment.
The registry lists 6 outcome measures. The named secondary outcomes include low-luminance reading acuity change, best-corrected visual acuity change, and geographic atrophy area change measured by fundus autofluorescence. Whether these outcomes and time points were treated as separate hypotheses, ordered in a testing hierarchy, or adjusted for multiplicity is not reported in the registry record. Because no analyses are listed, the record does not support a conclusion about how multiplicity was addressed in practice.
The primary population description specifies participants randomized and given at least one dose, with baseline and at least one post-baseline value for LL BCVA or geographic atrophy area on OCT. The description also notes early study discontinuation for some participants. The number included in each primary analysis, the reasons for discontinuation, and the amount or pattern of missing outcome data are not reported in the registry record.
Missing-data methods can affect estimates when follow-up is incomplete. In general, an analysis may use available measurements, impute missing values, or apply a model with assumptions about why observations are missing. Each approach relies on assumptions that should be stated and examined. The record does not report the method used, sensitivity analyses, or whether missingness was handled differently by group. It also does not report whether the analysis was intention-to-treat or another named analysis population. Thus, the endpoint population description is available, but the analysis population and missing-data approach cannot be fully characterized.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Elamipretide | 18 | 117 | 15.4% |
| Placebo | 6 | 59 | 10.2% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Elamipretide | 2 of 117 |
| Placebo | 0 of 59 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 3% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Elamipretide | 83 of 117 |
| Placebo | 36 of 59 |
Most frequent serious adverse event terms
| Event term | Organ system | Elamipretide | Placebo |
|---|---|---|---|
| Corona virus infection | Infections and infestations | 2 of 117 | 0 of 59 |
| Cholelithiasis | Hepatobiliary disorders | 2 of 117 | 0 of 59 |
| Pneumonia | Infections and infestations | 2 of 117 | 0 of 59 |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 117 | 1 of 59 |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | 1 of 117 | 0 of 59 |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | 1 of 117 | 0 of 59 |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | 1 of 117 | 0 of 59 |
| Generalised tonic-clonic seizure | Nervous system disorders | 1 of 117 | 0 of 59 |
| Gastric ulcer | Gastrointestinal disorders | 1 of 117 | 0 of 59 |
| Diverticulitis | Infections and infestations | 1 of 117 | 0 of 59 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Elamipretide | Placebo |
|---|---|---|---|
| Injection Site Pruritus | General disorders | 46 of 117 | 0 of 59 |
| Injection Site Pain | General disorders | 33 of 117 | 6 of 59 |
| Injection Site Bruising | General disorders | 15 of 117 | 11 of 59 |
| Injection Site Erythema | General disorders | 22 of 117 | 0 of 59 |
| Injection Site Haemorrhage | General disorders | 17 of 117 | 4 of 59 |
| Injection Site Induration | General disorders | 16 of 117 | 3 of 59 |
| Injection Site Hypertrophy | General disorders | 10 of 117 | 4 of 59 |
| Injection Site Mass | General disorders | 13 of 117 | 0 of 59 |
| Neovascular Age-related Macular Degeneration | Eye disorders | 8 of 117 | 5 of 59 |
| Injection Site Swelling | General disorders | 11 of 117 | 0 of 59 |
Serious events with the highest arm-level rate: corona virus infection (1.7%), cholelithiasis (1.7%), pneumonia (1.7%), squamous cell carcinoma of skin (1.7%), lung carcinoma cell type unspecified stage iv (1.7%).
The registry reports serious adverse events among 117 participants at risk in the elamipretide group and 59 at risk in the placebo group. Serious events were recorded for 18 participants in the elamipretide group and 6 in the placebo group. Deaths were recorded for 2 participants in the elamipretide group and 0 in the placebo group. These counts describe what is posted for each group; they do not by themselves establish that study treatment caused an event or death.
The record also lists other adverse events for 83 participants at risk in the elamipretide group and 36 at risk in the placebo group. These figures are separate from the serious-event counts in the registry’s adverse-event information. The record does not provide a comparative statistical analysis, event-exposure adjustment, or causal assessment for these counts. They should not be interpreted as rates calculated over person-time or as a complete account of severity and duration.
The listed top serious-event terms are Corona virus infection, Cholelithiasis, Pneumonia, Squamous cell carcinoma of skin, Lung carcinoma cell type unspecified stage IV, and Fall. Each is listed as 1.7%. The record does not assign these listed terms to a particular treatment group in the information summarized for this analysis. A term’s appearance in this list does not establish a relationship to treatment. Safety interpretation also depends on definitions, follow-up, event ascertainment, and participant exposure; those details are not fully reported in the registry record.
12. What the Result Does, and Does Not, Mean
The record establishes that ReCLAIM-2 was a Phase 2 randomized, masked, placebo-controlled study of once-daily subcutaneous elamipretide versus placebo in subjects with age-related macular degeneration with non-central geographic atrophy. It also identifies change from baseline in LL BCVA score as the primary outcome and specifies the scheduled assessments. These details describe the study question and measurement plan, but they are not evidence of the comparative outcome.
The posted registry information does not include an analyzed primary endpoint comparison, group-level changes, variability estimates, confidence intervals, or p-values. As a result, it does not show whether the groups differed in average LL BCVA change, how large any difference was, or how precisely it was estimated. The absence of a reported analysis should not be read as evidence that the groups were equal, or that a difference was present. Neither conclusion is supported by the outcome information.
The serious adverse-event and death counts provide descriptive safety information for the groups as recorded. They do not establish cause, comparative risk, or the relationship of an event to elamipretide. The serious-event terms and percentages also cannot be interpreted as treatment-specific findings because the record does not assign those terms to a group in the information summarized for this analysis.
More broadly, an endpoint definition, trial design, and enrollment number cannot substitute for estimates from the completed study. Interpretation of efficacy would require the analyzed results and a clear account of the analysis population, missing data, and uncertainty. Interpretation of safety would benefit from comparable event definitions and exposure information. Since those details are not reported in the registry record, the study description can clarify what was intended to be evaluated, but cannot support a conclusion about treatment efficacy or comparative safety.
13. Why This Trial Matters Statistically
This trial is statistically notable for the distinction between a clearly described outcome and a reported outcome analysis. The registry identifies a continuous primary measure, states its scale and direction, and gives a sequence of planned assessment times through Week 48. Those details help define what a treatment comparison would need to estimate. However, the registry record lists no analyses and does not report an estimate for the primary comparison. A well-defined endpoint does not by itself answer the study question.
The multiple planned time points make the analysis plan especially important. Repeated measurements from the same participants are related, and comparisons across more than one assessment can raise multiplicity concerns. Without the selected primary contrast, model, and testing strategy, readers cannot determine how the investigators intended to combine or prioritize information across visits. The same issue applies to the listed secondary outcomes, which cover visual function and geographic atrophy area.
The study also illustrates why descriptive safety counts and inferential efficacy results should be kept distinct. Serious-event counts and deaths are reported, but the registry does not provide a comparative analysis or causal interpretation. Meanwhile, the primary visual-acuity outcome has no posted treatment estimate or measure of precision. These differences in reporting mean that the available evidence is not evenly detailed across outcome domains.
For clinical researchers and biostatisticians, the central statistical lesson is that design labels, endpoint definitions, and enrollment counts are only part of the evidence. Transparent reporting of estimates, uncertainty, analysis populations, missing-data methods, and multiplicity procedures is needed to evaluate the strength and limits of a trial’s findings. Those analytic details are not reported in the registry record for this study.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The principal limitation for interpreting efficacy is that the registry record does not report an analyzed result for the primary endpoint. There are no group-level LL BCVA changes, standard deviations, treatment-effect estimates, confidence intervals, or p-values in the information summarized for this analysis. The registry lists no analyses and notes that the primary outcome has multiple categories or time points rather than a single reduced comparison. Therefore, the primary treatment contrast cannot be reconstructed or assessed.
The outcome population description includes participants with baseline and at least one post-baseline value for LL BCVA or geographic atrophy area on OCT, and notes that some participants discontinued early. The record does not give the number analyzed for the primary endpoint, the extent of missing data, reasons for discontinuation, or methods used to address missingness. It does not report whether the analysis followed an intention-to-treat principle or another population definition.
Although several assessment times and secondary outcomes are named, the statistical model, selected comparison, multiplicity strategy, and analysis methods are not reported in the registry record. The trial-specific sample-size justification is also not reported. Planning calculations based on an observed effect are illustrations and cannot establish what the study was originally designed to detect or provide evidence about the observed outcome.
Safety interpretation is limited by the descriptive nature of the posted event counts. The registry information does not provide an inferential group comparison, exposure-adjusted rates, or causal attribution. The listed serious-event terms are not assigned to a treatment group in the information summarized for this analysis. These gaps limit comparisons between groups and any assessment of whether an event was related to treatment.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: ReCLAIM-2 Study to Evaluate Safety,Efficacy & Pharmacokinetics of Elamipretide in Subjects With AMD With Non-central GA — NCT03891875.
- Registry record last updated 2024-07-12; status last verified 2024-07.
- Results first posted 2023-10-17.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
ReCLAIM-2 (NCT03891875) was a completed Phase 2 randomized, parallel, placebo-controlled study sponsored by Stealth BioTherapeutics Inc. It enrolled 176 subjects with age-related macular degeneration with non-central geographic atrophy. The elamipretide group received a once-daily 40 mg subcutaneous injection for 48 weeks, followed by a 4 week follow-up period; the placebo group followed the same stated schedule. The registry categorizes masking as quadruple.
The primary outcome was change from baseline in LL BCVA score, measured in letters, with Week 48 identified as the end-of-treatment assessment. The registry lists 6 outcome measures and no analyses. It does not report a primary treatment-effect estimate or the statistical methods used to analyze it. Serious adverse events were recorded for 18 of 117 participants at risk in the elamipretide group and 6 of 59 in the placebo group; deaths were recorded for 2 and 0, respectively. These are descriptive counts, and the registry does not report a comparative or causal interpretation.