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An Open Label, Multi-centre, Phase I/II Dose Escalation Trial of a Recombinant Adeno-associated Virus Vector (AAV2/8-hG1.7p.coCNGA3) for Gene Therapy of Children and Adults With Achromatopsia Owing to Defects in CNGA3

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Trial Profile

An Open Label, Multi-centre, Phase I/II Dose Escalation Trial of a Recombinant Adeno-associated Virus Vector (AAV2/8-hG1.7p.coCNGA3) for Gene Therapy of Children and Adults With Achromatopsia Owing to Defects in CNGA3

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 03 Dec 2022

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At a glance

  • Drugs Aguracingene cadoparvovec (Primary)
  • Indications Colour vision defects
  • Focus Adverse reactions; First in man; Pharmacogenomic; Therapeutic Use
  • Acronyms CNGA3
  • Sponsors MeiraGTx

Most Recent Events

  • 10 Feb 2022 Primary endpoint has changed from Incidence of Adverse Events related to the treatment to Reduction in visual acuity by 15, Early Treatment Diabetic Retinopathy Study (ETDRS) letters or more that fails to resolve to within 15 letters of baseline in a 4-week period once prophylactic treatment commences, Severe unresponsive inflammation, Infective endophthalmitis, Ocular malignancy, Grade III or above non-ocular Suspected Unexpected Serious Adverse Reaction (SUSAR), according to ClinicalTrials.gov
  • 24 Jun 2021 Status changed from recruiting to completed.
  • 11 May 2021 According to MeiraGTx Holdings media release, the company has completed dosing of both adults and pediatric patients in this study.

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