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

Sponsor
Stealth BioTherapeutics Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03891875
Collaborator
(none)
176
Enrollment
37
Locations
2
Arms
36.6
Actual Duration (Months)
4.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: Subcutaneous elamipretide through the elamipretide delivery system
  • Combination Product: Subcutaneos placebo through the elamipretide delivery system
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
176 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 27, 2019
Actual Primary Completion Date :
Feb 22, 2022
Actual Study Completion Date :
Apr 14, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Elamipretide

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
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.
Other Names:
  • elamipretide
  • MTP-131
  • Bendavia

    		•
    Placebo Comparator: Placebo

    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
    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.

    Outcome Measures

    Primary Outcome Measures

    1. To evaluate the efficacy of elamipretide in looking at the change in low-luminance best-corrected visual acuity [Baseline to week 48]

    2. To evaluate the efficacy of elamipretide through the change in GA area as measured by optical coherence tomography [Baseline to week 48]

    Secondary Outcome Measures

    1. To evaluate the efficacy of elamipretide through change in low-luminance ready acuity [Baseline to week 48]

    2. To evaluate the efficacy of elamipretide through best-corrected visual acuity [Baseline to week 48]

    3. To evaluate the efficacy of elamipretide through the change in GA area as measured by fundus autofluorescence [Baseline to week 48]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Associated Retina Consultants, Ltd. Peoria Arizona United States 85381
    2 Retinal Research Institute, LLC Phoenix Arizona United States 85014
    3 Arizona Retina & Vitreous Consultants Phoenix Arizona United States 85021
    4 Retinal Research Institute, LLC Phoenix Arizona United States 85053
    5 Global Retina Institute Scottsdale Arizona United States 85254
    6 California Retina Consultants Bakersfield California United States 93309
    7 Retina-Vitreous Associates Medical Group Beverly Hills California United States 90211
    8 Retina Institute of California Medical Group Palm Desert California United States 92260
    9 California Retina Consultants Santa Barbara California United States 93103
    10 California Retina Consultants Santa Maria California United States 93454
    11 Bascom Palmer Eye Institute Miami Florida United States 33136
    12 MedEye Associates Miami Florida United States 33143
    13 Bascom Palmer Eye Institute Palm Beach Gardens Florida United States 33418
    14 Center for Retina and Macular Disease Winter Haven Florida United States 33880
    15 Southeast Retina Center, PC Augusta Georgia United States 30909
    16 The Retina Care Center Baltimore Maryland United States 21209
    17 Cumberland valley retina consultants Hagerstown Maryland United States 21740
    18 Ophthalmic Consultants of Boston Boston Massachusetts United States 02114
    19 New England Retina Consultants Springfield Massachusetts United States 01107
    20 Specialty Eye Institute Jackson Michigan United States 49202
    21 Retina Center of New Jersey LLC Bloomfield New Jersey United States 07003
    22 New Jersey Retina Teaneck New Jersey United States 07666
    23 Retina Associates of Western New York Rochester New York United States 14620
    24 Duke Eye center Durham North Carolina United States 27705
    25 Sterling Research Group Cincinnati Ohio United States 45202
    26 Oklahoma University Health Sciences Center Oklahoma City Oklahoma United States 73104
    27 Retina Northwest, P.C Portland Oregon United States 97221
    28 Black Hills Regional Eye Institute Rapid City South Dakota United States 57701
    29 Tennessee Retina Nashville Tennessee United States 37203
    30 Retina Research Institute of Texas Abilene Texas United States 79606
    31 Retina Research Center, PLLC Austin Texas United States 78705
    32 Ophthalmology Associates Fort Worth Texas United States 76102
    33 Texas Retina Associates Fort Worth Texas United States 76104
    34 Retina Consultants of Houston, PA Houston Texas United States 77030
    35 Retina Consultants of Houston Katy Texas United States 77494
    36 Valley Retina Institute, PA McAllen Texas United States 78503
    37 University of Virginia, Department of Ophthalmology Charlottesville Virginia United States 22903

    Sponsors and Collaborators

    • Stealth BioTherapeutics Inc.

    Investigators

    • Study Director: Sathyanarayana, Stealth BioTherapeutics

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stealth BioTherapeutics Inc.
    ClinicalTrials.gov Identifier:
    NCT03891875
    Other Study ID Numbers:
    • SPIAM-202
    First Posted:
    Mar 27, 2019
    Last Update Posted:
    May 26, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Stealth BioTherapeutics Inc.
    AMD
    Macular degeneration
    non-central geographic atrophy
    MTP-131
    elamipretide
    Additional relevant MeSH terms:
    Macular Degeneration
    Geographic Atrophy

    Study Results

    No Results Posted as of May 26, 2022