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

Completed · Phase 2 · Has a placebo group

Conditions studied: Age-related Macular Degeneration

In brief

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.

Key facts

Study ID: NCT03891875
Run by: Stealth BioTherapeutics Inc.
People needed: 176
Starts: 2019-03-27
Expected to finish: 2022-04-14
Last updated by the study team: 2024-07-12

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

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 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.

Where it is running

Associated Retina Consultants, Ltd. — Peoria, Arizona, United States
Retinal Research Institute, LLC — Phoenix, Arizona, United States
Arizona Retina & Vitreous Consultants — Phoenix, Arizona, United States
Retinal Research Institute, LLC — Phoenix, Arizona, United States
Global Retina Institute — Scottsdale, Arizona, United States
California Retina Consultants — Bakersfield, California, United States
Retina-Vitreous Associates Medical Group — Beverly Hills, California, United States
Retina Institute of California Medical Group — Palm Desert, California, United States
California Retina Consultants — Santa Barbara, California, United States
California Retina Consultants — Santa Maria, California, United States
Bascom Palmer Eye Institute — Miami, Florida, United States
MedEye Associates — Miami, Florida, United States
Bascom Palmer Eye Institute — Palm Beach Gardens, Florida, United States
Center for Retina and Macular Disease — Winter Haven, Florida, United States
Southeast Retina Center, PC — Augusta, Georgia, United States
The Retina Care Center — Baltimore, Maryland, United States
Cumberland valley retina consultants — Hagerstown, Maryland, United States
Ophthalmic Consultants of Boston — Boston, Massachusetts, United States
New England Retina Consultants — Springfield, Massachusetts, United States
Specialty Eye Institute — Jackson, Michigan, United States
Retina Center of New Jersey LLC — Bloomfield, New Jersey, United States
New Jersey Retina — Teaneck, New Jersey, United States
Retina Associates of Western New York — Rochester, New York, United States
Duke Eye center — Durham, North Carolina, United States
Sterling Research Group — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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