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Age-related Macular DegenerationPhase 2ReCLAIM-2NCT03891875

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

A Phase 2 study testing Subcutaneous elamipretide through the elamipretide delivery system in people with Age-related Macular Degeneration, run by Stealth BioTherapeutics Inc. at 37 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Age-related Macular Degeneration
What is being tested?
Subcutaneous elamipretide through the elamipretide delivery system
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
176 participants
Where
37 sitesUnited States
Study dates
27 Mar 2019to 14 Apr 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • be ≥ 0.05 mm2 and ≤ 10.16 mm2 and
  • reside completely within the FAF 30 or 35 degree image.
  • must be at least 150 μm from foveal center with preserved outer retinal structural details
Show all 13Show fewer
  • 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

Who cannot join

  • 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.
Show all 41Show fewer
  • 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.

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

United States37 sites

  • Retina Research Institute of Texas

    Abilene, Texas, 79606

  • Southeast Retina Center, PC

    Augusta, Georgia, 30909

  • Retina Research Center, PLLC

    Austin, Texas, 78705

  • California Retina Consultants

    Bakersfield, California, 93309

  • The Retina Care Center

    Baltimore, Maryland, 21209

  • Retina-Vitreous Associates Medical Group

    Beverly Hills, California, 90211

  • Retina Center of New Jersey LLC

    Bloomfield, New Jersey, 07003

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts, 02114

  • University of Virginia, Department of Ophthalmology

    Charlottesville, Virginia, 22903

  • Sterling Research Group

    Cincinnati, Ohio, 45202

  • Duke Eye center

    Durham, North Carolina, 27705

  • Ophthalmology Associates

    Fort Worth, Texas, 76102

  • Texas Retina Associates

    Fort Worth, Texas, 76104

  • Cumberland valley retina consultants

    Hagerstown, Maryland, 21740

  • Retina Consultants of Houston, PA

    Houston, Texas, 77030

  • Specialty Eye Institute

    Jackson, Michigan, 49202

  • Retina Consultants of Houston

    Katy, Texas, 77494

  • Valley Retina Institute, PA

    McAllen, Texas, 78503

  • Bascom Palmer Eye Institute

    Miami, Florida, 33136

  • MedEye Associates

    Miami, Florida, 33143

  • Tennessee Retina

    Nashville, Tennessee, 37203

  • Oklahoma University Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Bascom Palmer Eye Institute

    Palm Beach Gardens, Florida, 33418

  • Retina Institute of California Medical Group

    Palm Desert, California, 92260

  • Associated Retina Consultants, Ltd.

    Peoria, Arizona, 85381

  • Retinal Research Institute, LLC

    Phoenix, Arizona, 85014

  • Arizona Retina & Vitreous Consultants

    Phoenix, Arizona, 85021

  • Retinal Research Institute, LLC

    Phoenix, Arizona, 85053

  • Retina Northwest, P.C

    Portland, Oregon, 97221

  • Black Hills Regional Eye Institute

    Rapid City, South Dakota, 57701

  • Retina Associates of Western New York

    Rochester, New York, 14620

  • California Retina Consultants

    Santa Barbara, California, 93103

  • California Retina Consultants

    Santa Maria, California, 93454

  • Global Retina Institute

    Scottsdale, Arizona, 85254

  • New England Retina Consultants

    Springfield, Massachusetts, 01107

  • New Jersey Retina

    Teaneck, New Jersey, 07666

  • Center for Retina and Macular Disease

    Winter Haven, Florida, 33880

Other trials in United States

About this study

Official title: A Phase 2 Randomized, Double-Masked, Placebo-Controlled Clinical Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Elamipretide in Subjects With Age-Related Macular Degeneration With Non-central Geographic Atrophy

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.

Read the detailed description

This was a randomized, double-masked, placebo controlled study using three periods to evaluate the safety, efficacy and pharmacokinetics of elamipretide in subjects with Age-Related Macular Degeneration with non-central Geographic Atrophy. The total duration of subject participation was up to 54 weeks, including a Screening Period (≤2 weeks), Treatment Period (48 weeks), and Follow-up (4 weeks). 176 eligible subjects were randomized in a 2:1 ratio (elamipretide:placebo) to receive 40 mg elamipretide or placebo. The study drug (i.e., elamipretide or placebo) was administered once daily via SC injection using the elamipretide delivery system during the 48 week Treatment Period. After completion of the 48-week Treatment Period subjects continued to be monitored for safety during the 4-week Follow-up Period and an end of study (EOS) Follow-up Visit was conducted at Week 52.

Being tested
Subcutaneous elamipretide through the elamipretide delivery system, Subcutaneos placebo through the elamipretide delivery system
Keywords
AMD, Macular degeneration, non-central geographic atrophy, MTP-131, elamipretide
Medical subject headings
Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Subcutaneous elamipretide through the elamipretide delivery systemCombination product

    Also called elamipretide, MTP-131, Bendavia

    Subjects will be randomized in a 2:1 ratio to receive either elamipretide or placebo through the elamipretide delivery system. Subjects will dose daily for up to 48 weeks.

  • Subcutaneos placebo through the elamipretide delivery systemCombination product

    Subjects will be randomized in a 2:1 ratio to receive either elamipretide or placebo through the elamipretide delivery system. Subjects will dose daily for up to 48 weeks.

Study groups in NCT03891875
Study groupRoleWhat they receive
ElamipretideExperimentalOnce daily 40 mg subcutaneous injection of elamipretide using the elamipretide delivery system for 48 weeks followed by a 4 week follow-up period.
Receives: Combination Product: Subcutaneous elamipretide through the elamipretide delivery system
PlaceboPlacebo comparatorOnce daily subcutaneous injection of placebo using the elamipretide delivery system for 48 weeks followed by a 4 week follow-up period.
Receives: Combination Product: Subcutaneos placebo through the elamipretide delivery system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. LL BCVA Score Change From Baseline

    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).

    Measured: Baseline and Weeks 4, 8, 12, 24, 36, 48

  2. GA Area Change From Baseline by OCT

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

    Measured: Baseline and Weeks 12, 24, 36, 48

Secondary outcomes (3)

  1. LL RA Change From Baseline

    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.

    Measured: Baseline and Weeks 4,12, 36, 48

  2. BCVA Change From Baseline

    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).

    Measured: Baseline and Weeks 4, 8, 12, 24, 36, 48

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

    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.

    Measured: Baseline and Weeks 12, 24, 36, 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2019
  2. Study start27 Mar 2019
  3. Primary completion22 Feb 2022
  4. Study completion14 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
176 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03891875
Sponsor's protocol ID
SPIAM-202
Acronym
ReCLAIM-2
Status last verified
Jul 2024
First submitted
25 Mar 2019
Last updated
12 Jul 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Ehlers JP, Hu A, Boyer D, Cousins SW, Waheed NK, Rosenfeld PJ, Brown D, Kaiser PK, Abbruscato A, Gao G, Heier J; ReCLAIM-2 (SPIAM-202) Study Investigators. ReCLAIM-2: A Randomized Phase II Clinical Trial Evaluating Elamipretide in Age-related Macular Degeneration, Geographic Atrophy Growth, Visual Function, and Ellipsoid Zone Preservation. Ophthalmol Sci. 2024 Oct 9;5(1):100628. doi: 10.1016/j.xops.2024.100628. eCollection 2025 Jan-Feb.

    PubMed 39605874

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Subcutaneous elamipretide through the elamipretide delivery system in people with Age-related Macular Degeneration, run by Stealth BioTherapeutics Inc. at 37 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

LL BCVA Score Change From Baseline (time frame: Baseline and Weeks 4, 8, 12, 24, 36, 48). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03891875, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.

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