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

  • STATUS
    Recruiting
  • End date
    Mar 5, 2022
  • participants needed
    180
  • sponsor
    Stealth BioTherapeutics Inc.
Updated on 5 October 2020
Investigator
Rekha Sathyanarayana
Primary Contact
The Retina Care Center (6.7 mi away) Contact
+46 other location
geographic atrophy
retinopathy
diabetic retinopathy
mydriasis
atrophy
age-related macular degeneration

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.

Details
Treatment Subcutaneous elamipretide through the elamipretide delivery system, Subcutaneos placebo through the elamipretide delivery system
Clinical Study IdentifierNCT03891875
SponsorStealth BioTherapeutics Inc.
Last Modified on5 October 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 55 yrs?
Gender: Male or Female
Do you have any of these conditions: Macular Degeneration or age-related macular degeneration?
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 m 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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