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

NCT03891875 | Completed Phase 2 Results FDA Drug

• 1 other identifier: SPIAM-202
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 37

Brief 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.

Conditions

Age-related Macular Degeneration

Keywords

AMD; Macular degeneration; non-central geographic atrophy; MTP-131; elamipretide

Outcome Measures

Primary Outcomes (2)

• 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).

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

• 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)

  Baseline and Weeks 12, 24, 36, 48

Secondary Outcomes (3)

• LL RA Change From Baseline

  Baseline and Weeks 4,12, 36, 48

• BCVA Change From Baseline

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

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

  Baseline and Weeks 12, 24, 36, 48

Other Outcomes (1)

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

  Baseline, Week 24 and Week 48

Study Arms (2)

Elamipretide

EXPERIMENTAL

Once daily 40 mg subcutaneous injection of elamipretide using the elamipretide delivery system for 48 weeks followed by a 4 week follow-up period.

Combination Product: Subcutaneous elamipretide through the elamipretide delivery system

Placebo

PLACEBO COMPARATOR

Once daily subcutaneous injection of placebo using the elamipretide delivery system for 48 weeks followed by a 4 week follow-up period.

Combination Product: Subcutaneos placebo through the elamipretide delivery system

Interventions

Subcutaneous elamipretide through the elamipretide delivery system COMBINATION_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.

Also known as: elamipretide, MTP-131, Bendavia

Elamipretide

Subcutaneos placebo through the elamipretide delivery system COMBINATION_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.

Placebo

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Stealth BioTherapeutics Inc.: lead

Study Sites (37)

Associated Retina Consultants, Ltd.

Peoria, Arizona, 85381, United States

Location

Retinal Research Institute, LLC

Phoenix, Arizona, 85014, United States

Location

Arizona Retina & Vitreous Consultants

Phoenix, Arizona, 85021, United States

Location

Retinal Research Institute, LLC

Phoenix, Arizona, 85053, United States

Location

Global Retina Institute

Scottsdale, Arizona, 85254, United States

Location

California Retina Consultants

Bakersfield, California, 93309, United States

Location

Retina-Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

Retina Institute of California Medical Group

Palm Desert, California, 92260, United States

Location

California Retina Consultants

Santa Barbara, California, 93103, United States

Location

California Retina Consultants

Santa Maria, California, 93454, United States

Location

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

MedEye Associates

Miami, Florida, 33143, United States

Location

Bascom Palmer Eye Institute

Palm Beach Gardens, Florida, 33418, United States

Location

Center for Retina and Macular Disease

Winter Haven, Florida, 33880, United States

Location

Southeast Retina Center, PC

Augusta, Georgia, 30909, United States

Location

The Retina Care Center

Baltimore, Maryland, 21209, United States

Location

Cumberland valley retina consultants

Hagerstown, Maryland, 21740, United States

Location

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

New England Retina Consultants

Springfield, Massachusetts, 01107, United States

Location

Specialty Eye Institute

Jackson, Michigan, 49202, United States

Location

Retina Center of New Jersey LLC

Bloomfield, New Jersey, 07003, United States

Location

New Jersey Retina

Teaneck, New Jersey, 07666, United States

Location

Retina Associates of Western New York

Rochester, New York, 14620, United States

Location

Duke Eye center

Durham, North Carolina, 27705, United States

Location

Sterling Research Group

Cincinnati, Ohio, 45202, United States

Location

Oklahoma University Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Retina Northwest, P.C

Portland, Oregon, 97221, United States

Location

Black Hills Regional Eye Institute

Rapid City, South Dakota, 57701, United States

Location

Tennessee Retina

Nashville, Tennessee, 37203, United States

Location

Retina Research Institute of Texas

Abilene, Texas, 79606, United States

Location

Retina Research Center, PLLC

Austin, Texas, 78705, United States

Location

Ophthalmology Associates

Fort Worth, Texas, 76102, United States

Location

Texas Retina Associates

Fort Worth, Texas, 76104, United States

Location

Retina Consultants of Houston, PA

Houston, Texas, 77030, United States

Location

Retina Consultants of Houston

Katy, Texas, 77494, United States

Location

Valley Retina Institute, PA

McAllen, Texas, 78503, United States

Location

University of Virginia, Department of Ophthalmology

Charlottesville, Virginia, 22903, United States

Location

Related Publications (1)

• 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.

  PMID: 39605874 DERIVED

MeSH Terms

Conditions

Macular Degeneration

Interventions

arginyl-2,'6'-dimethyltyrosyl-lysyl-phenylalaninamide

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Results Point of Contact

• Title: Jim Carr, Pharm.D. Chief Clinical Development Officer
• Organization: Stealth BioTherapeutics, Inc

jim.carr@stealthbt.com

1-617-600-6888

Study Officials

• Sathyanarayana

  Stealth BioTherapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: March 27, 2019
• Study Start: March 27, 2019
• Primary Completion: February 22, 2022
• Study Completion: April 14, 2022
• Last Updated: July 12, 2024
• Results First Posted: October 17, 2023

Record last verified: 2024-07

Locations

US (37)