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

NCT01521793 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2014-07-28

No results posted yet for this study

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

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
2012-01-31
Primary Completion
2014-05-31
Completion
2014-06-30

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 NCT01521793 on ClinicalTrials.gov