Clinical Trial: Repeated Treatments of QLT091001 in Subjects With Leber Congenital Amaurosis or Retinitis Pigmentosa (Extension of Study RET IRD 01)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An Open-Label Study to Evaluate the Effects of Repeated Treatments of Oral QLT091001 on Safety and Vision Outcome in Subjects With Leber Congenital Amaurosis (LCA) or Reti
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 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.
Detailed Summary:
Sponsor: QLT Inc.
Current Primary Outcome: Visual field [ Time Frame: 12 months ]
Original Primary Outcome: Visual field [ Time Frame: 12 months ]
Current Secondary Outcome: Safety will be assessed by evaluating the following: adverse events, clinical laboratory tests, ECG's and vital signs [ Time Frame: 12 months ]
Original Secondary Outcome:
- Best corrected visual acuity [ Time Frame: 12 months ]Scores and changes from baseline
- Color Vision [ Time Frame: 12 months ]Change from baseline
- Retinal thickness and fluorescence [ Time Frame: 12 months ]Change from baseline
Information By: QLT Inc.
Dates:
Date Received: January 6, 2012
Date Started: January 2012
Date Completion:
Last Updated: July 25, 2014
Last Verified: July 2014