Status:

COMPLETED

Clinical Trial of Gene Therapy for the Treatment of Leber Congenital Amaurosis (LCA)

Lead Sponsor:

MeiraGTx UK II Ltd

Conditions:

Leber Congenital Amaurosis

Eligibility:

All Genders

3+ years

Phase:

PHASE1

PHASE2

Brief Summary

A clinical trial of AAV2/5 vector for patients with Defects in RPE65

Detailed Description

A dose escalation and dose expansion (Phase I/II) trial of adults and children with retinal dystrophy associated with defects in RPE65. ATIMP will be administered to one eye only in a single sub-retin...

Eligibility Criteria

Inclusion

  • Key
  • Aged 3 years or older
  • Early-onset severe retinal dystrophy consistent with RPE65 deficiency
  • Key

Exclusion

  • Females who are pregnant or breastfeeding
  • Have participated in another research study involving an investigational therapy for ocular disease within the last 6 months.

Key Trial Info

Start Date :

April 1 2016

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2018

Estimated Enrollment :

15 Patients enrolled

Trial Details

Trial ID

NCT02781480

Start Date

April 1 2016

End Date

December 1 2018

Last Update

July 12 2021

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Kellogg Eye Centre, University of Michigan

Ann Arbor, Michigan, United States, 48105

2

Moorfields Eye Hospital NHS Foundation Trust

London, United Kingdom, EC1V 2PD

Clinical Trial of Gene Therapy for the Treatment of Leber Congenital Amaurosis (LCA) | DecenTrialz