LL BCVA Score Change From Baseline
| Group | Value (Letters) | Spread |
|---|---|---|
| Elamipretide | 0.7 | 6.11 |
| Placebo | -0.6 | 5.93 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataShort name ReCLAIM-2
United States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
A randomized, double-masked, placebo-controlled study to evaluate the safety, efficacy and pharmacokinetics of elamipretide in subjects with Age-Related Macular Degeneration with non-central Geographic Atrophy.
Experimental
Elamipretide
Once daily 40 mg subcutaneous injection of elamipretide using the elamipretide delivery system for 48 weeks followed by a 4 week follow-up period.
Placebo comparator
Placebo
Once daily subcutaneous injection of placebo using the elamipretide delivery system for 48 weeks followed by a 4 week follow-up period.
Outcomes the sponsor listed as primary.
LL BCVA Score Change From Baseline
Time frame · Baseline and Weeks 4, 8, 12, 24, 36, 48
Change in low luminance best corrected visual acuity (LL BCVA) score from Baseline to the end of treatment (EOT; Week 48) assessment measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) scale. ETDRS charts present a series of five letters of equal difficulty on each row, with standardized spacing between letters and rows; there is a total of 14 lines (70 letters), with letter size increasing further geometrically and equivalently in every line by a factor of 1.2589 (or 0.1 log unit), moving up the chart. Minimum score of zero, maximum score of 100. Change from baseline: a more negative score is worse outcome, a more positive score is better outcome. A lower score means less letters were read correctly (worse outcome) and a higher score means more letters were read correctly (better outcome).
GA Area Change From Baseline by OCT
Time frame · Baseline and Weeks 12, 24, 36, 48
Geographic atrophy (GA) area: change from baseline as measured by optical coherence tomography (OCT) from Baseline to the end of treatment (EOT; Week 48)
LL RA Change From Baseline
Time frame · Baseline and Weeks 4,12, 36, 48
Low-luminance ready acuity (LL RA) score change from baseline to the EOT (Week 48). Mean Critical Print Size with Low Luminance in Weeks 4, 12, 36, 48 as measured by the Logarithm of the Minimum Angle of Resolution LogMAR chart. Scores range from -0.3 to 1.0, where higher number means worse acuity/worse outcome, a lower number means better acuity/better outcome.
BCVA Change From Baseline
Time frame · Baseline and Weeks 4, 8, 12, 24, 36, 48
Best-corrected visual acuity (BCVA) change from Baseline Change in best corrected visual acuity (BCVA) score from Baseline to the end of treatment (EOT; Week 48) assessment measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) scale. ETDRS charts present a series of five letters of equal difficulty on each row, with standardized spacing between letters and rows; there is a total of 14 lines (70 letters), with letter size increasing further geometrically and equivalently in every line by a factor of 1.2589 (or 0.1 log unit), moving up the chart. Minimum score of zero, maximum score of 100. Change from baseline: a more negative score is worse outcome, a more positive score is better outcome. A lower score means less letters were read correctly (worse outcome) and a higher score means more letters were read correctly (better outcome).
GA Area as Measured by Fundus Autofluorescence (FAF) Change From Baseline
Time frame · Baseline and Weeks 12, 24, 36, 48
Change from Baseline in Mean Area of Geographic Atrophy (GA) by Fundus Autofluorescence (FAF) at Week 24. Fluorescein angiography (FA) was used to examine the circulation of the retina and choroid using fluorescein dye and a specialized camera to trace the dye. Fundus autofluorescence imaging of the retinal pigment epithelium and neurosensory retina was performed within 14 days of Day 0 and at every visit with the exception of Day 0 and Day 7. Atrophy is characterized by loss of the retinal pigment epithelium (RPE), overlying photoreceptors and underlying choriocapillaris. Greater area affected means a worse outcome than smaller area affected.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Letters) | Spread |
|---|---|---|
| Elamipretide | 0.7 | 6.11 |
| Placebo | -0.6 | 5.93 |
| Group | Value (mm^2) | Spread |
|---|---|---|
| Elamipretide | 0.082 | 0.0889 |
| Placebo | 0.071 | 0.0812 |
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Elamipretide | -0.005 | 0.2678 |
| Placebo | 0.029 | 0.3169 |
| Group | Value (Letters) | Spread |
|---|---|---|
| Elamipretide | 0.3 | 4.03 |
| Placebo | -0.1 | 4.51 |
| Group | Value (mm^2) | Spread |
|---|---|---|
| Elamipretide | 0.074 | 0.0690 |
| Placebo | 0.065 | 0.0804 |
| Group | Value (percentage of EZ total attentuation) | Spread |
|---|---|---|
| Elamipretide | 1.81 | 3.889 |
| Placebo | 2.70 | 3.291 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Elamipretide40 mg daily subcutaneous injection of elamipretide using the elamipretide delivery system for 48 weeks followed by a 4 week follow-up period. | 2 / 117 | 18 / 117 | 83 / 117 |
| PlaceboDaily subcutaneous injection of placebo using the elamipretide delivery system for 48 weeks followed by a 4 week follow-up period. | 0 / 59 | 6 / 59 | 36 / 59 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
1 study on this page
PubMed tag: none · 2025
Ehlers et al. 2025Ophthalmology sciencecited by 27
PMID 39605874PMC11599447DOI 10.1016/j.xops.2024.100628PUB-39605874
Who could join, as posted.
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