Repeated Treatments of QLT091001 in Subjects With Leber Congenital Amaurosis or Retinitis Pigmentosa (Extension of Study RET IRD 01)

Completed · Phase 1

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

In brief

The purpose of this study is: * To evaluate the safety of up to 3 additional courses of oral QLT091001 administered once daily for 7 days in subjects treated previously with a single 7-day course of QLT091001 in Study RET IRD 01 * To evaluate whether up to 3 additional courses of oral QLT091001 administered once daily for 7 days can maintain or improve visual function.

Key facts

Study ID

NCT01521793

Run by

QLT Inc.

People needed

27

Starts

2012-01-01

Expected to finish

2014-06-01

Last updated by the study team

2014-07-28

Who can join

Age: 5 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with LCA or RP due to RPE65 or LRAT deficiency who received a 7-day treatment course of QLT091001 and completed the Day 30 visit in Study RET IRD 01
• Subjects who meet any one of the following criteria at least 1 month after start of the 7-day treatment course in Study RET IRD 01:
• no increase in GVF (in at least 1 eye): Follow-up GVF increased ≤20% from baseline or
• decrease in GVF (in at least 1 eye): Follow-up GVF decreased below the highest previous response by ˃20% or
• Considered a reasonable candidate for retreatment, based on the Investigator's discretion, in consultation with the independent DSMB and the Sponsor, based on regression or lack of response in other parameters of visual function (e.g., subjective reports of changes in color vision or adaptation to low light) but who do not meet other (GVF) criteria for study entry

You may not qualify if…

• Subjects with any clinically important abnormal physical finding at Screening.
• Subjects who have taken any prescription or investigational oral retinoid medication (e.g., Accutane,® Soriatane®) within 6 months of Day 0 and subjects who did not tolerate their previous oral retinoid medication will be excluded regardless of the time of last exposure.
• Subjects with liver failure, uncontrolled thyroid disease, hypersensitivity to retinoids, or hypervitaminosis A
• Subjects who have taken any supplements containing ≥10,000 IU vitamin A within 60 days of screening

Where it is running

• The Chicago Lighthouse (University of Illinois at Chicago, Pangere Center for Inherited Retinal Disease) — Chicago, Illinois, United States
• Wilmer Eye Institute (Johns Hopkins University) — Baltimore, Maryland, United States
• Montreal Children's Hospital, McGill University Health Centre — Montreal, Quebec, Canada
• Institute for Ophthalmic Research, University of Tubingen — Tübingen, Germany
• The Rotterdam Eye Hospital — Rotterdam, Netherlands
• Moorefield Eye Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

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