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Trial · Interventional

CompletedPhase 2Results postedRegistry data

ReCLAIM-2 Study to Evaluate Safety,Efficacy & Pharmacokinetics of Elamipretide in Subjects With AMD With Non-central GA

Short name ReCLAIM-2

Overview

Status
Completed
Phase
Phase 2
Enrollment
176 participants (actual)
Sponsor
Stealth BioTherapeutics Inc. · Industry
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
27 Mar 2019
Primary completion
22 Feb 2022
Completion
14 Apr 2022
First posted
27 Mar 2019
Last update posted
12 Jul 2024
Conditions
Age-related Macular Degeneration

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20192020202120222023
  1. Ph 2

    ReCLAIM-2

    NCT03891875

    27 Mar 2019 to 14 Apr 2022

Registry summary

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.

Interventions

  • Subcutaneous elamipretide through the elamipretide delivery systemCombination product
  • Subcutaneos placebo through the elamipretide delivery systemCombination product

Arms2

  • 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.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. LL BCVA Score Change From Baseline

    Time frame · Baseline and Weeks 4, 8, 12, 24, 36, 48

    Registry description

    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).

  2. GA Area Change From Baseline by OCT

    Time frame · Baseline and Weeks 12, 24, 36, 48

    Registry description

    Geographic atrophy (GA) area: change from baseline as measured by optical coherence tomography (OCT) from Baseline to the end of treatment (EOT; Week 48)

Secondary outcomes(3)
  1. LL RA Change From Baseline

    Time frame · Baseline and Weeks 4,12, 36, 48

    Registry description

    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.

  2. BCVA Change From Baseline

    Time frame · Baseline and Weeks 4, 8, 12, 24, 36, 48

    Registry description

    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).

  3. GA Area as Measured by Fundus Autofluorescence (FAF) Change From Baseline

    Time frame · Baseline and Weeks 12, 24, 36, 48

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline and Weeks 4, 8, 12, 24, 36, 48

LL BCVA Score Change From Baseline

GroupValue (Letters)Spread
Elamipretide0.76.11
Placebo-0.65.93
Primary outcomeMean· Baseline and Weeks 12, 24, 36, 48

GA Area Change From Baseline by OCT

GroupValue (mm^2)Spread
Elamipretide0.0820.0889
Placebo0.0710.0812
Secondary and other outcome results(4)
Secondary outcomeMean· Baseline and Weeks 4,12, 36, 48

LL RA Change From Baseline

GroupValue (units on a scale)Spread
Elamipretide-0.0050.2678
Placebo0.0290.3169
Secondary outcomeMean· Baseline and Weeks 4, 8, 12, 24, 36, 48

BCVA Change From Baseline

GroupValue (Letters)Spread
Elamipretide0.34.03
Placebo-0.14.51
Secondary outcomeMean· Baseline and Weeks 12, 24, 36, 48

GA Area as Measured by Fundus Autofluorescence (FAF) Change From Baseline

GroupValue (mm^2)Spread
Elamipretide0.0740.0690
Placebo0.0650.0804
Other pre specified outcomeMean· Baseline, Week 24 and Week 48

Macular Percentage of Ellipsoid Zone (EZ) Total Attenuation From Baseline

GroupValue (percentage of EZ total attentuation)Spread
Elamipretide1.813.889
Placebo2.703.291

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther 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 / 11718 / 11783 / 117
PlaceboDaily subcutaneous injection of placebo using the elamipretide delivery system for 48 weeks followed by a 4 week follow-up period.0 / 596 / 5936 / 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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

PubMed tag: none · 2025

7 results

ReCLAIM-2: A Randomized Phase II Clinical Trial Evaluating Elamipretide in Age-related Macular Degeneration, Geographic Atrophy Growth, Visual Function, and Ellipsoid Zone Preservation.

Ehlers et al. 2025Ophthalmology sciencecited by 27

PMID 39605874PMC11599447DOI 10.1016/j.xops.2024.100628PUB-39605874

Free to read · publisher termsCC BY-NC-ND7 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 55 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Adults ≥ 55 years of age with at least 1 eye with AMD with non-central GA as determined by FAF. Ocular conditions-study eye * GA in the study eye at the Screening Visit may be multi-focal, but the cumulative GA lesion and size must: 1. be ≥ 0.05 mm2 and ≤ 10.16 mm2 and 2. reside completely within the FAF 30 or 35 degree image. 3. must be at least 150 μm from foveal center with preserved outer retinal structural details * No evidence of CNV by history, OCT or FA in the study eye. * BCVA by Early Treatment Diabetic Retinopathy Study (ETDRS) score of ≥ 55 letters (Snellen equivalent ≥ 20/70) in the study eye at the Screening Visit and Baseline Visit. * LL BCVA by ETDRS score of ≥ 10 letters in the study eye at the Screening Visit and Baseline Visit. * LL VA deficit (defined as difference the between BCVA and LL BCVA) of \> 5 letters in the study eye at Screening and Baseline Visits. * The fellow eye may have any of the following: no AMD, AMD without GA, AMD with GA, CNV AMD, or central GA. Ongoing treatment with anti-angiogenic therapies in the fellow eye is allowable. * Sufficiently clear ocular media, adequate pupillary dilation, fixation to permit quality fundus imaging, and ability to cooperate sufficiently for adequate ophthalmic visual function testing and anatomic assessment in the study eye. Systemic and general criteria Exclusion Criteria: Ocular conditions-study eye * The absence of observable hyper-FAF at the margins of the GA in the study eye(only for lesions ≥ 0.25mm2) * Atrophic retinal disease of causality other than AMD including myopia-related maculopathy and monogenetic macular dystrophies including pattern dystrophy and adult-onset Stargardt disease in the study eye. * Presence or diagnosis of exudative AMD or CNV in the study eye. * Presence of retinal vein occlusion in the study eye. * Presence of diabetic retinopathy (a history of diabetes mellitus without retinopathy is not a criterion for exclusion) in either eye. * Presence of vitreous hemorrhage in the study eye. * History of retinal detachment in the study eye. * History of macular hole (stages 2 to 4) in the study eye. * Presence of an epiretinal membrane that causes distortion of the retinal contour in the study eye. * Presence of vitreomacular traction in the study eye. * At the Screening Visit, advanced glaucoma resulting in a cup to disc ratio of \> 0.8 in the study eye. * History of glaucoma filtration surgery or uncontrolled glaucoma defined as IOP \> 22 mmHg at baseline despite anti-glaucoma treatment with or without topical anti-hypertensive eye drops in the study eye OR currently using \> 2 medications (note: combination medications count as 2 medications). * Presence of visually significant cataract OR presence of significant posterior capsular opacity in the setting of pseudophakia. Significant cataract is defined as \> +2 nuclear sclerosis based upon the scale below or any Posterior Subcapsular Cataract in the study eye. The Sponsor, or its designee, will supply the trial sites with a copy of the standard photographs. * Presence of significant keratopathy or any other media or corneal opacity that would cause scattering of light or alter visual function, especially in LL conditions in the study eye. * Ocular incisional or laser surgery (including cataract surgery) in the study eye within 90 days before Day 1. * Yag laser capsulotomy in the study eye within 30 days before Day 1. * Aphakia in the study eye. * History of vitrectomy surgery, submacular surgery, or any vitreoretinal surgery in the study eye. * Prior treatment with Visudyne® (verteporfin) ocular photodynamic therapy, external-beam radiation therapy (for intraocular conditions), or transpupillary thermotherapy in the study eye. * History of subthreshold laser treatment or other forms of photobiomodulation for AMD in the study eye. * Intravitreal drug delivery in the past 60 days or 5-half-lives of the injected drug whichever is longer (e.g., intravitreal corticosteroid injection, anti angiogenic drugs, or device implantation) in the study eye. * Current use of medications known to be toxic to the lens, retina, or optic nerve (e.g., deferoxamine, chloroquine/hydroxychloroquine \[Plaquenil®\], tamoxifen, phenothiazines, ethambutol, digoxin, and aminoglycosides) from the Screening Visit through the completion of the trial. Ocular conditions--either eye * History of herpetic infection in either eye. * Concurrent disease in either the study eye or fellow control eye that could require medical or surgical intervention during the study period. * Active uveitis and/or vitritis (grade trace or above) in either eye. * History of idiopathic or autoimmune-associated uveitis in either eye. * Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye. Systemic conditions. * Known to be immunocompromised or receiving systemic immunosuppression for ≥ 4 consecutive weeks prior to screening. * Any disease or medical condition that in the opinion of the Investigator would prevent the subject from successfully participating in the study or might confound study results. General * Participation in other investigational drug or device clinical studies within 30 days of enrollment and/or planning to participate in any other investigational drug or device clinical studies within 30 days of study completion. * History of allergy to fluorescein that is not amenable to treatment. * Creatinine clearance of ≤ 30 mL/min at the Screening Visit (using Modification of Diet in Renal Disease Study formula). * Inability to comply with study or follow-up procedures. * Inability to obtain color fundus photograph, FAF, and FA of sufficient quality to be analyzed and interpreted. * Active malignancy or any other cancer from which the subject has been cancer-free for \< 2 years. * History of allergic reaction to the investigational drug or any of its components. * Prior treatment with Elamipretide.

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