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Trial record 80 of 184 for:    RET

Evaluation of the Effects of Oral QLT091001 in Adults With Impaired Dark Adaptation

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ClinicalTrials.gov Identifier: NCT01999764
Recruitment Status : Completed
First Posted : December 3, 2013
Last Update Posted : July 14, 2015
Sponsor:
Information provided by (Responsible Party):
QLT Inc.

Brief Summary:
This is a Phase IIa proof-of-concept study to evaluate the effects of oral QLT091001 on adults with impaired dark adaptation.

Condition or disease Intervention/treatment Phase
Impaired Dark Adaptation Drug: QLT091001 Other: Placebo Phase 2

Detailed Description:

This proof-of-concept study is a randomized, parallel design of two different oral doses of QLT091001 compared to placebo to evaluate treatment effects in patients with impaired dark adaptation.

Approximately 40 subjects will be enrolled in this study at approximately 7 centers in the US.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of the Effects of Oral QLT091001 in Adults With Impaired Dark Adaptation
Study Start Date : November 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo (for QLT091001)
Placebo is supplied to mimic QLT091001 oral solution.
Other: Placebo
Placebo is administered orally at multiple time points.

Experimental: QLT091001 - first oral dose
Subjects will receive an oral dose of 10mg/m2 of QLT091001.
Drug: QLT091001
QLT091001 administered orally at multiple time points.

Experimental: QLT091001 - second oral dose
Subjects will receive an oral dose of 40 mg/m2 of QLT091001.
Drug: QLT091001
QLT091001 administered orally at multiple time points.




Primary Outcome Measures :
  1. Visual Acuity [ Time Frame: Through 7 weeks ]
    Low luminance low contrast best-corrected visual acuity (LLLC BCVA) will be measured at multiple time points.


Secondary Outcome Measures :
  1. Dark Adaptation Time [ Time Frame: Through 7 weeks ]
    Dark Adaptation Time will be measured at multiple time points.


Other Outcome Measures:
  1. Glare Recovery [ Time Frame: Through 7 weeks ]
    Glare recovery time will be measured at multiple time points.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects ≥60 yrs with early age-related macular degeneration (AMD) based on LLLC BCVA criterion or evidence of impaired dark adaptation
  • Subjects with high luminance high contrast best-corrected visual acuity (HLHC BCVA) of 40 letters (20/40 Snellen) or better in the study eye
  • Capable and willing to provide consent

Exclusion Criteria:

  • Women of child bearing potential
  • Subjects with late AMD or any other optic neuropathy in the study eye
  • Subjects with posterior subcapsular cataract or multifocal intra-ocular lens (IOL) in the study eye
  • Subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 60 days of Day 0 or who have taken any prescription/investigational oral retinoid medication within 6 months of Day 0
  • Subjects taking age-related eye disease study (AREDS) supplements containing beta-carotene

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): NCT01999764


Locations
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United States, California
Sall Research Medical Center
Artesia, California, United States, 90701
California Retina Consultants
Santa Barbara, California, United States, 93103
United States, Massachusetts
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States, 02114
United States, Texas
Keystone Research Ltd.
Austin, Texas, United States, 78731
Retina Foundation of the Southwest
Dallas, Texas, United States, 75231
Retina Consultants of Houston
Houston, Texas, United States, 77030
United States, Washington
Proliance Surgeons Inc.
Seattle, Washington, United States, 98004
Sponsors and Collaborators
QLT Inc.
Investigators
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Study Director: Sushanta Mallick, Ph.D MBA QLT Inc.

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Responsible Party: QLT Inc.
ClinicalTrials.gov Identifier: NCT01999764     History of Changes
Other Study ID Numbers: RET IDA 02
First Posted: December 3, 2013    Key Record Dates
Last Update Posted: July 14, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Vitamin A
Retinol acetate
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Anticarcinogenic Agents
Protective Agents
Antineoplastic Agents
Vitamins
Micronutrients
Nutrients
Growth Substances