July 2019
Volume 60, Issue 9
Free
ARVO Annual Meeting Abstract  |   July 2019
Effects of the Mitochondria-Targeted Drug Elamipretide on Leakage-Independent Vision Loss in Fellow Eyes with Neovascular AMD in the ReCLAIM Study
Author Affiliations & Notes
  • Priyatham S Mettu
    Ophthalmology / Duke Eye Center, Duke University School of Medicine, Durham, North Carolina, United States
  • Michael John Allingham
    Ophthalmology / Duke Eye Center, Duke University School of Medicine, Durham, North Carolina, United States
  • Scott W Cousins
    Ophthalmology / Duke Eye Center, Duke University School of Medicine, Durham, North Carolina, United States
  • Footnotes
    Commercial Relationships   Priyatham Mettu, Stealth BioTherapeutics (F), Stealth BioTherapeutics (C); Michael Allingham, Stealth BioTherapeutics (F), Stealth BioTherapeutics (C); Scott Cousins, Stealth BioTherapeutics (F), Stealth BioTherapeutics (C)
  • Footnotes
    Support  Sponsored Research Agreement from Stealth BioTherapeutics
Investigative Ophthalmology & Visual Science July 2019, Vol.60, 358. doi:
  • Views
  • Share
  • Tools
    • Alerts
      ×
      This feature is available to authenticated users only.
      Sign In or Create an Account ×
    • Get Citation

      Priyatham S Mettu, Michael John Allingham, Scott W Cousins; Effects of the Mitochondria-Targeted Drug Elamipretide on Leakage-Independent Vision Loss in Fellow Eyes with Neovascular AMD in the ReCLAIM Study. Invest. Ophthalmol. Vis. Sci. 2019;60(9):358.

      Download citation file:


      © ARVO (1962-2015); The Authors (2016-present)

      ×
  • Supplements
Abstract

Purpose : Assess the effects of the mitochondria-targeted drug elamipretide on leakage-independent vision loss in fellow, non-study eyes with neovascular age-related macular degeneration (NV AMD) in the ReCLAIM Study, an open-label, phase 1 clinical trial to evaluate safety, tolerability, and efficacy of elamipretide in dry AMD.

Methods : Eligible participants had a single designated study eye with dry AMD (either high-risk drusen or noncentral geographic atrophy); the fellow, non-study eye could have any stage of dry or NV AMD disease. All participants received daily subcutaneous elamipretide (40 mg) for 24 weeks, and study assessments were performed for both study eye and fellow, non-study eye of participants every four weeks, with outcomes assessed at week 24. The present analysis includes only fellow, non-study eyes with either quiescent NV AMD (i.e. no fluid, leakage, or hemorrhage and stable maintenance anti-VEGF treatment regimen) or stable inactive NV AMD. Visual function studies included standard luminance best-corrected visual acuity (BCVA) and low luminance visual acuity (LLVA), defined as BCVA through a log 2 neutral density filter.

Results : Of 40 participants who received study drug, a total of thirteen had fellow, non-study eyes with either quiescent NV AMD (n= 8) or stable inactive NV AMD (n= 5), with all eyes free from exudation and hemorrhage. The mean change in standard BCVA in fellow eyes with NV AMD was +6.3 ± 5.0 letters (p < 0.001) (baseline mean BCVA: 53.4 ± 21.9 letters, range: 19-88 letters;), with ≥ 6-letter BCVA gain in 54% of fellow eyes and ≥ 10-letter BCVA gain in 31% of fellow eyes. The mean change in LLVA in fellow eyes with NV AMD was +6.4 ± 4.8 letters (p < 0.001) (baseline mean LLVA: 35.2 ± 22.9 letters, range: 6-74 letters), with ≥ 6-letter LLVA gain in 54% of fellow eyes and ≥ 10-letter LLVA gain in 31% of fellow eyes.

Conclusions : Subcutaneous administration of elamipretide, a mitochondria-targeted drug, was associated with improved vision in fellow, non-study eyes with NV AMD in a phase 1 clinical trial of elamipretide for dry AMD. Further study is warranted to understand the biology of retinal mitochondrial dysfunction in NV AMD and to assess the efficacy of elamipretide for treatment of leakage-independent vision loss in NV AMD.

This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.

×
×

This PDF is available to Subscribers Only

Sign in or purchase a subscription to access this content. ×

You must be signed into an individual account to use this feature.

×