NCT02714816|Completed
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Sponsor study identifier
observational
37
2 countries
2
Study Start
April 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 22, 2023
Actual (reported)Study Completion
July 22, 2023
Actual (reported)MGT005 is a natural history study to collect longitudinal prospective data from patients with Leber Congenital Amaurosis associated with defects in RPE65.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 22, 2023
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 8, 2016
Actual (reported)March 22, 2016
Actual (reported)April 2016
Date type not reportedThis date has not been verified as actual or estimated.
July 22, 2023
Actual (reported)July 22, 2023
Actual (reported)Analysis of retinal structure and function
Retinal structure will be analysed using Adaptive optics and SD-OCT and Fundal autofluorescence. This will be correlated with assessment of visual acuity, psychophysical visual assessment, visual mobility, retinal sensitivity and visual fields
6 years
Quality of Life Questionnaires
6 years
Retinal Sensitivity
6 years
Retinal Structural analysis
6 years
Fundal Autofluorescence
6 years
Assessment of Visual Fields
6 years
Patients with RPE65-LCA condition
Kellogg Eye Center
Ann Arbor, Michigan, MI 48105, United States
Moorfields Eye Hospital
London, United Kingdom
Kumaran N, Georgiou M, Bainbridge JWB, Bertelsen M, Larsen M, Blanco-Kelly F, Ayuso C, Tran HV, Munier FL, Kalitzeos A, Michaelides M. Retinal Structure in RPE65-Associated Retinal Dystrophy. Invest Ophthalmol Vis Sci. 2020 Apr 9;61(4):47. doi: 10.1167/iovs.61.4.47.
Kumaran N, Rubin GS, Kalitzeos A, Fujinami K, Bainbridge JWB, Weleber RG, Michaelides M. A Cross-Sectional and Longitudinal Study of Retinal Sensitivity in RPE65-Associated Leber Congenital Amaurosis. Invest Ophthalmol Vis Sci. 2018 Jul 2;59(8):3330-3339. doi: 10.1167/iovs.18-23873.
Michel Michealides, Prof
UCL/Moorfileds
37 participants (actual enrollment reported by the registry).
First Submitted
March 8, 2016
First Posted
March 22, 2016
Study Start
April 2016
Date type not reportedThis date has not been verified as actual or estimated.
Clinical Gene Therapy Protocol for the Treatment of Retinal Dystrophy Caused by Defects in RPE65
Contact the study team to confirm eligibility.
Primary Completion
July 22, 2023
Actual (reported)Study Completion
July 22, 2023
Actual (reported)Last Updated
September 21, 2026
Record last verified: 2026-09
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Source: ClinicalTrials.gov.
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