ReNEW:Phase 3 Study of Efficacy, Safety & Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Related Macular Degeneration (Dry AMD)

Exclusion Criteria

• •Subjects who meet any of the following criteria at the Screening and Baseline Visit (unless otherwise specified) will be excluded from the trial:
• •Ocular Conditions - Study Eye:
• •1. The absence of observable hyper-FAF at the margins of the GA in the study eye at the Screening Visit by the Reading Center
• •2. 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
• •3. Evidence of exudative AMD or CNV in the study eye by history or FA , as determined by the Reading Center
• •4. Presence of retinal vein occlusion in the study eye
• •5. Presence of vitreous hemorrhage in the study eye
• •6. History of retinal detachment in the study eye
• •7. History of macular hole (stages 2 to 4) in the study eye
• •8. Presence of an epiretinal membrane and/or vitreomacular traction in the study eye that causes distortion of the retinal contour
• •9. Presence of any retinal pathology in the study eye that prohibits outer retinal quantification and EZ mapping, as determined at the Screening Visit by the Reading Center
• •10. At the Screening Visit, advanced glaucoma resulting in a cup to disc ratio of \> 0.8 in the study eye
• •11. History of glaucoma filtration surgery or uncontrolled glaucoma at Baseline Visit in the opinion of the Investigator OR currently using ≥ 3 medications (Minimally invasive glaucoma surgeries (e.g., MIGS) are allowable) Note: Combination medications count as 2 medications.
• •12. Presence of visually significant cataract OR presence of significant posterior capsular opacity in the setting of pseudophakia Note: Significant cataract is defined as ≥ +3 nuclear sclerosis based upon the scale below or any Posterior Subcapsular Cataract in the study eye. The Sponsor, or its designee, will supply the clinical trial sites with a copy of the standard photographs. Grade Description
• •* 1 Opacity is absent
• •* 2 Opacity is present, but less than Nuclear Standard Photograph #2
• •* 3 Opacity is present, and as severe as or worse than Nuclear Standard Photograph #2 Source: (Chew 2010)
• •13. 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
• •14. Ocular incisional or laser surgery (including cataract surgery) in the study eye within 90 days before the Baseline Visit
• •15. YAG laser capsulotomy in the study eye within 30 days before the Baseline Visit
• •16. Aphakia in the study eye
• •17. History of vitrectomy surgery, submacular surgery, or any vitreoretinal surgery in the study eye
• •18. Prior treatment with Visudyne® (verteporfin) ocular photodynamic therapy, external-beam radiation therapy (for intraocular conditions), or transpupillary thermotherapy in the study eye
• •19. History of subthreshold laser treatment or other forms of photobiomodulation for AMD in the study eye
• •20. Intravitreal drug delivery in the past 60 days or 5-half-lives from the Baseline Visit of the injected drug whichever is longer (e.g., intravitreal corticosteroid injection, anti-angiogenic drugs, or device implantation) in the study eye
• •21. Intravitreal drug delivery of a complement inhibitor in the past 6 months from the Baseline Visit in the study eye
• •22. Concurrent disease in the study eye that could require medical or surgical intervention during the trial
• •Ocular conditions - Either Eye:
• •23. Presence or a history of diabetic retinopathy in either eye (a history of diabetes mellitus without retinopathy is not a criterion for exclusion)
• •24. History of herpetic infection in either eye
• •25. Active uveitis and/or vitritis (grade trace or above) in either eye
• •26. History of idiopathic or autoimmune-associated uveitis in either eye
• •27. Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
• •Systemic Conditions:
• •28. Has a history of a systemic eosinophilic illness and/or an eosinophil count \>1,000 cells x106/L (equivalent to \>1 cell x 103/μL) at the Screening Visit
• •29. History of solid organ transplant
• •30. Any disease or medical condition that in the opinion of the Investigator would prevent the subject from successfully participating in the trial or might confound trial results
• •31. 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)
• •32. eGFR of \< 30 mL/min at the Screening Visit (using the CKD-EPI 2021 formula)
• •General Conditions:
• •33. Participation in other investigational drug or device clinical trials within 30 days or 5 half-lives (whichever is longer) of Screening; or is currently enrolled in a non-interventional clinical trial that, in the opinion of the Investigator, may be potentially confounding to the results of the current trial
• •34. Women who are pregnant, planning to become pregnant, or breastfeeding/lactating
• •35. History of allergy to fluorescein that is not amenable to treatment
• •36. Inability to comply with trial or follow-up procedures
• •37. Inability to obtain CFP, FAF, and FA of sufficient quality to be analyzed and interpreted
• •38. Active malignancy or any other cancer from which the subject has been cancer-free for \< 2 years. Localized squamous or non-invasive basal cell skin carcinomas are allowed, if appropriately treated prior to screening
• •39. History of allergic reaction to the investigational drug or any of its components
• •40. Prior participation in any elamipretide trial