Repeated Treatments of QLT091001 in Subjects With Leber Congenital Amaurosis (LCA) or Retinitis Pigmentosa (RP) (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)
We have completed a Phase 1b multi-center, open-label clinical trial of repeated treatments of QLT091001 in patients with LCA and autosomal recessive RP due to inherited mutations in RPE65 or LRAT. In this study, patients that were treated with a single course of QLT091001 in our previously completed Phase 1b clinical trial received up to three 7-day courses of QLT091001 to assess visual outcomes and safety following retreatment. Visual field (VF) was assessed using Goldmann Visual Field (GVF) and visual acuity (VA) was assessed using best-corrected visual acuity (BCVA) at baseline and days 7, 14, 30 and 60 after each treatment course, then bimonthly until the next treatment course. Patients received treatment with QLT091001 at doses of 10, 40 or 60 mg/m2, with the majority of patients receiving 40 mg/m2. Retreatment was initially determined based on established retreatment criteria or at Investigator discretion. This was later amended to allow retreatment to occur as early as 30 days but no later than 60 days after a previous treatment course to maintain dosing within a fixed interval.
Positive results of Phase 1b retreatment study were reported on September 12, 2014.
For more information, visit ClinicalTrials.gov.
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