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

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ClinicalTrials.gov Identifier: NCT01521793
Recruitment Status : Completed
First Posted : January 31, 2012
Last Update Posted : July 28, 2014
Sponsor:
Information provided by (Responsible Party):
QLT Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
LCA (Leber Congenital Amaurosis) RP (Retinitis Pigmentosa) Drug: QLT091001 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : January 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : June 2014

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Arms and Interventions
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Intervention Details:
  • Drug: QLT091001
    oral QLT091001 administered once daily for 7 days

Outcome Measures
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Primary Outcome Measures :
  1. Visual field [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Safety will be assessed by evaluating the following: adverse events, clinical laboratory tests, ECG's and vital signs [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   5 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with LCA or RP due to RPE65 or LRAT deficiency who received a 7-day treatment course of QLT091001 and completed the Day 30 visit in Study RET IRD 01

  • Subjects who meet any one of the following criteria at least 1 month after start of the 7-day treatment course in Study RET IRD 01:

    • no increase in GVF (in at least 1 eye): Follow-up GVF increased ≤20% from baseline or
    • decrease in GVF (in at least 1 eye): Follow-up GVF decreased below the highest previous response by ˃20% or
    • Considered a reasonable candidate for retreatment, based on the Investigator's discretion, in consultation with the independent DSMB and the Sponsor, based on regression or lack of response in other parameters of visual function (e.g., subjective reports of changes in color vision or adaptation to low light) but who do not meet other (GVF) criteria for study entry

Exclusion Criteria:

  • Subjects with any clinically important abnormal physical finding at Screening.
  • Subjects who have taken any prescription or investigational oral retinoid medication (e.g., Accutane,® Soriatane®) within 6 months of Day 0 and subjects who did not tolerate their previous oral retinoid medication will be excluded regardless of the time of last exposure.
  • Subjects with liver failure, uncontrolled thyroid disease, hypersensitivity to retinoids, or hypervitaminosis A
  • Subjects who have taken any supplements containing ≥10,000 IU vitamin A within 60 days of screening
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01521793


Locations
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United States, Illinois
The Chicago Lighthouse (University of Illinois at Chicago, Pangere Center for Inherited Retinal Disease)
Chicago, Illinois, United States, 60608
United States, Maryland
Wilmer Eye Institute (Johns Hopkins University)
Baltimore, Maryland, United States, 21287
Canada, Quebec
Montreal Children's Hospital, McGill University Health Centre
Montreal, Quebec, Canada
Germany
Institute for Ophthalmic Research, University of Tubingen
Tubingen, Germany
Netherlands
The Rotterdam Eye Hospital
Rotterdam, Netherlands
United Kingdom
Moorefield Eye Hospital
London, United Kingdom, EC1 V2PD
Sponsors and Collaborators
QLT Inc.
Investigators
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Study Director: Sushanta Mallick QLT Inc.
More Information
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Responsible Party: QLT Inc.
ClinicalTrials.gov Identifier: NCT01521793    
Other Study ID Numbers: RET IRD 02
First Posted: January 31, 2012    Key Record Dates
Last Update Posted: July 28, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Blindness
Retinitis
Retinitis Pigmentosa
Leber Congenital Amaurosis
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn
Vision Disorders
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Retinol acetate
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Anticarcinogenic Agents
Protective Agents
Antineoplastic Agents