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

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

Study Overview

• Status: Completed
• Conditions: Impaired Dark Adaptation
• Intervention / Treatment: Other: Placebo; Drug: QLT091001

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.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Artesia, California, United States, 90701
      • Sall Research Medical Center
    • Santa Barbara, California, United States, 93103
      • California Retina Consultants
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Ophthalmic Consultants of Boston
  • Texas
    • Austin, Texas, United States, 78731
      • Keystone Research Ltd.
    • Dallas, Texas, United States, 75231
      • Retina Foundation of the Southwest
    • Houston, Texas, United States, 77030
      • Retina Consultants of Houston
  • Washington
    • Seattle, Washington, United States, 98004
      • Proliance Surgeons Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity	Low luminance low contrast best-corrected visual acuity (LLLC BCVA) will be measured at multiple time points.	Through 7 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dark Adaptation Time	Dark Adaptation Time will be measured at multiple time points.	Through 7 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glare Recovery	Glare recovery time will be measured at multiple time points.	Through 7 weeks

Collaborators and Investigators

• Sponsor: QLT Inc.
• Investigators: Study Director: Sushanta Mallick, Ph.D MBA, QLT Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: November 25, 2013
• First Submitted That Met QC Criteria: November 25, 2013
• First Posted (Estimate): December 3, 2013

Study Record Updates

• Last Update Posted (Estimate): July 14, 2015
• Last Update Submitted That Met QC Criteria: June 16, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antineoplastic Agents; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Anticarcinogenic Agents; Retinol acetate
• Other Study ID Numbers: RET IDA 02