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

Phase 2

Completed

• Conditions: Impaired Dark Adaptation
• Interventions: Drug: QLT091001; Other: Placebo

• Registration Number: NCT01999764
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-25
• Study First Submitted QC: 2013-11-25
• Study First Posted: 2013-12-03
• Primary Completion: 2014-06
• Study Completion: 2014-07
• Status Verified: 2015-06
• Disposition First Submitted: 2015-06-16
• Disposition First Submitted QC: 2015-06-16
• Last Update Submitted: 2015-06-16
• Disposition First Posted: 2015-07-14
• Last Update Posted: 2015-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
QLT091001 - second oral dose	QLT091001	Subjects will receive an oral dose of 40 mg/m2 of QLT091001.
Placebo (for QLT091001)	Placebo	Placebo is supplied to mimic QLT091001 oral solution.
QLT091001 - first oral dose	QLT091001	Subjects will receive an oral dose of 10mg/m2 of QLT091001.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Dark Adaptation Time	Through 7 weeks	Dark Adaptation Time will be measured at multiple time points.

Trial Locations

Locations (7)

Proliance Surgeons Inc.; 🇺🇸 Seattle, Washington, United States

Ophthalmic Consultants of Boston; 🇺🇸 Boston, Massachusetts, United States

Retina Foundation of the Southwest; 🇺🇸 Dallas, Texas, United States

Retina Consultants of Houston; 🇺🇸 Houston, Texas, United States

California Retina Consultants; 🇺🇸 Santa Barbara, California, United States

Keystone Research Ltd.; 🇺🇸 Austin, Texas, United States

Sall Research Medical Center; 🇺🇸 Artesia, California, United States