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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

NCT01014052 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2013-05-14

No results posted yet for this study

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)

Conditions

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

Interventions

DRUG

QLT091001

oral QLT091001 administered once daily for 7 days

Sponsors & Collaborators

  • QLT Inc.

    lead INDUSTRY

Principal Investigators

  • Sushanta Mallick · QLT Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States
  • Canada
  • Germany
  • Netherlands
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01014052 on ClinicalTrials.gov