Clinical Trial: Safety/Proof of Concept Study of Oral QLT091001 in Subjects With Leber Congenital Amaurosis (LCA) or Retinitis Pigmentosa (RP) Due to Retinal Pigment Epithelial 65 Protein (RPE65) or Lecithin:Retinol Acyltransferase (LRAT) Mutations
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase 1b Study to Evaluate QLT091001 in Subjects With Leber Congenital Amaurosis (LCA) or Retinitis Pigmentosa (RP) Due to Inherited Deficiencies of Retinal Pigment Epithe
Brief Summary:
The purpose of this study is:
- to evaluate the safety of oral QLT091001
- to evaluate whether 7-day treatment with oral QLT091001 can improve visual function in subjects with LCA or RP due to RPE65 or LRAT mutations
- to evaluate duration of visual function improvement (if observed)
Detailed Summary:
Sponsor: QLT Inc.
Current Primary Outcome: Visual Field [ Time Frame: 12 months ]
Original Primary Outcome: Best-corrected visual acuity, color vision, visual fields, electroretinogram (ERG) and full-field stimulus threshold test (FST) [ Time Frame: 14 days ]
Current Secondary Outcome: Vital signs, clinical laboratory tests, electrocardiogram (ECG), and adverse events [ Time Frame: 12 months ]
Original Secondary Outcome: Vital signs, clinical laboratory tests, electrocardiogram (ECG), and adverse events [ Time Frame: 14 days ]
Information By: QLT Inc.
Dates:
Date Received: November 12, 2009
Date Started: November 2009
Date Completion:
Last Updated: May 13, 2013
Last Verified: May 2013
