Natural History Study in Inherited Retinal Disease Subjects Caused by Mutations in RPE65 or LRAT

Completed

Conditions studied: Leber Congenital Amaurosis (LCA), Retinitis Pigmentosa (RP)

In brief

To evaluate the natural history of visual function in subjects with IRD phenotypically diagnosed as Leber congenital amaurosis (LCA) or retinitis pigmentosa (RP) caused by RPE65 or LRAT gene mutations.

Key facts

Study ID

NCT02575430

Run by

QLT Inc.

People needed

59

Starts

2015-12-01

Expected to finish

2016-03-01

Last updated by the study team

2016-04-29

Who can join

Age: 8 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects aged 8 or older with IRD (LCA or RP) caused by inherited autosomal recessive mutation in either RPE65 or LRAT.
• Subjects who have at least 2 documented kinetic visual field assessments of the same isopter(s) in at least one eye performed at least 2 years apart on the same type of equipment when the subject was between the ages of 6 and 65 years.
• If applicable, subjects who provide informed consent for the study (the requirement for informed consent may be applicable to all sites or may be waived by the IRB and/or local regulations). The parent or guardian must sign an approved informed consent form for the study for subjects younger than the age of majority.

You may not qualify if…

• Subjects, who in the Investigator's opinion, have any severe acute or chronic medical condition, psychiatric condition, physical examination finding or laboratory abnormality that may interfere with the interpretation of their visual function data.
• Subjects with concomitant bilateral ocular disorders that may affect visual acuity or visual fields (e.g., advanced glaucoma, optic neuritis, anterior ischemic optic neuropathy, advanced cataract, intraocular surgery).

Where it is running

• Wilmer Eye Institute - Johns Hopkins Hospital — Baltimore, Maryland, United States
• Casey Eye Institute - Marquam Hill — Portland, Oregon, United States
• The Hospital for Sick Children, Ophthalmology and Vision Sciences — Toronto, Ontario, Canada
• Montreal Children's Hospital, McGill University Health Centre — Montreal, Quebec, Canada
• Glostrup Hospital and National Eye Clinic at the Kennedy Center — Glostrup Municipality, Copenhagen, Denmark
• STZ Eyetrial at the Department of Ophthalmology - University of Tübingen — Tübingen, Germany
• Rotterdam Ophthalmic Institute — Rotterdam, Netherlands
• Jules Gonin Eye Hospital - Oculogenetic Unit — Lausanne, Switzerland
• Moorfields Eye Hospital - Research and Treatment Centre — London, United Kingdom

Full record on ClinicalTrials.gov

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