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 ]

Percent changed from baseline


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