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On 28 May 2024, enrolment in phase III clinical trials for sozinibercept in neovascular age-related macular degeneration (nAMD) was completed.1 These trials include two large multicentre, double-masked, randomized controlled trials (RCTs): COAST (OPT-302 with aflibercept in neovascular age-related macular degeneration; ClinicalTrials.gov identifier: NCT04757636) and ShORe (OPT-302 with ranibizumab in neovascular age-related macular degeneration; ClinicalTrials.gov identifier: NCT04757610).2,3 These trials represent one of the largest phase […]

Mark Moster: RESCUE, REVERSE and RESTORE clinical trials: Investigating gene therapy for Leber’s hereditary optic neuropathy

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Published Online: Aug 15th 2022

Leber’s hereditary optic neuropathy (LHON) is characterized by bilateral, painless subacute loss of central vision during young adult life. We were delighted to speak with Prof. Mark Moster (Wills Eye Hospital, Philadelphia, PA, USA) to discuss the findings in the RESCUE, REVERSE and RESTORE clinical trials. 

Questions:

  1. Could you give us a brief overview of Leber’s hereditary optic neuropathy (LHON) and its prognosis? (00:23)
  2. Please could you describe the gene therapy you investigated in the RESCUE, REVERSE and RESTORE clinical trials? (01:21)
  3. What were the efficacy and safety findings from the RESCUE and REVERSE clinical trials? (02:13)
  4. What were the findings of the RESTORE long term follow up study? (03:57)
  5. What is the current status of the European Medicines Agency (EMA) regulatory review? (04:45)

Disclosures: Mark Moster is a consultant for Gensight Biologics, and discloses grant/research support from Gensight Biologics.

Support: Interview and filming supported by Touch Medical Media Ltd. Interview conducted by Shanice Allen.

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