Status:
COMPLETED
Repeated Treatments of QLT091001 in Subjects With Leber Congenital Amaurosis or Retinitis Pigmentosa (Extension of Study RET IRD 01)
Lead Sponsor:
QLT Inc.
Conditions:
LCA (Leber Congenital Amaurosis)
RP (Retinitis Pigmentosa)
Eligibility:
All Genders
5-65 years
Phase:
PHASE1
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01521793
Start Date
January 1 2012
End Date
June 1 2014
Last Update
July 28 2014
Active Locations (6)
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1
The Chicago Lighthouse (University of Illinois at Chicago, Pangere Center for Inherited Retinal Disease)
Chicago, Illinois, United States, 60608
2
Wilmer Eye Institute (Johns Hopkins University)
Baltimore, Maryland, United States, 21287
3
Montreal Children's Hospital, McGill University Health Centre
Montreal, Quebec, Canada
4
Institute for Ophthalmic Research, University of Tubingen
Tübingen, Germany