NCT01521793

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

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 Retinitis Pigmentosa (RP) Due to Inherited Deficiencies of Retinal Pigment Epithelial 65 Protein (RPE65) or Lecithin: Retinol Acyltransferase (LRAT) (Extension of Study RET IRD 01)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: QLT Inc. · Industry
• Sex: All
• Age: 5 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• LCA (Leber Congenital Amaurosis)
• RP (Retinitis Pigmentosa)

Interventions

Type	Name	Description
DRUG	QLT091001	oral QLT091001 administered once daily for 7 days

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-05-01
• Completion: 2014-06-01
• First posted: 2012-01-31
• Last updated: 2014-07-28

Locations

6 sites across 5 countries: United States, Canada, Germany, Netherlands, United Kingdom