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

Plain-language summary

This study investigated the natural course over time of inherited retinal disease caused by mutations in the RPE65 or LRAT genes, using a retrospective chart review. It included people aged 8 and older with inherited retinal disease (LCA or RP) due to an autosomal recessive mutation in RPE65 or LRAT. It was conducted as a non-phase study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Completed

Sponsor

QLT Inc.

Intervention

No treatment: retrospective chart review

Start date

12/1/2015

Estimated completion

3/1/2016

Countries

United States, Canada, Denmark, Germany, Netherlands, Switzerland, United Kingdom

Related genes

Locations

• Baltimore, United States
• Portland, United States
• Toronto, Canada
• Montreal, Canada
• Glostrup Municipality, Denmark
• Tübingen, Germany
• Rotterdam, Netherlands
• Lausanne, Switzerland
• London, United Kingdom

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).