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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03891875
Recruitment Status : Active, not recruiting
First Posted : March 27, 2019
Last Update Posted : March 1, 2021
Sponsor:
Information provided by (Responsible Party):
Stealth BioTherapeutics Inc.

Tracking Information
First Submitted Date  ICMJE March 25, 2019
First Posted Date  ICMJE March 27, 2019
Last Update Posted Date March 1, 2021
Actual Study Start Date  ICMJE March 27, 2019
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2019)
To evaluate the efficacy of elamipretide in looking at the change in low-luminance best-corrected visual acuity [ Time Frame: Baseline to week 48 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2019)
  • To evaluate the efficacy of elamipretide through change in low-luminance ready acuity [ Time Frame: Baseline to week 48 ]
  • To evaluate the efficacy of elamipretide through best-corrected visual acuity [ Time Frame: Baseline to week 48 ]
  • To evaluate the efficacy of elamipretide through the change in GA area as measured by fundus autofluorescence [ Time Frame: Baseline to week 48 ]
  • To evaluate the efficacy of elamipretide through the change in GA area as measured by optical coherence tomography [ Time Frame: Baseline to week 48 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: March 25, 2019)
  • To evaluate change in National Eye Institute Visual Function Questionnaire-39 [ Time Frame: Baseline to week 48 ]
  • To evaluate change in reading acuity at standard light [ Time Frame: Baseline to week 48 ]
  • To evaluate change in Visual function by the Low-luminance Questionnaire [ Time Frame: Baseline to week 48 ]
  • To evaluate conversion to choroidal neovascularization [ Time Frame: Baseline to week 48 ]
 
Descriptive Information
Brief Title  ICMJE ReCLAIM-2 Study to Evaluate Safety,Efficacy & Pharmacokinetics of Elamipretide in Subjects With AMD With Non-central GA
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Age-related Macular Degeneration
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • Experimental: Elamipretide
    40 mg subcutaneous injection of elamipretide using the elamipretide delivery system for 48 weeks followed by a 4 week follow-up period.
    Intervention: Combination Product: Subcutaneous elamipretide through the elamipretide delivery system
  • Placebo Comparator: Placebo
    subcutaneous injection of placebo using the elamipretide delivery system for 48 weeks followed by a 4 week follow-up period.
    Intervention: Combination Product: Subcutaneos placebo through the elamipretide delivery system
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: March 25, 2019)
180
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2022
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03891875
Other Study ID Numbers  ICMJE SPIAM-202
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stealth BioTherapeutics Inc.
Study Sponsor  ICMJE Stealth BioTherapeutics Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sathyanarayana Stealth BioTherapeutics
PRS Account Stealth BioTherapeutics Inc.
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP