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

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

Detailed Description
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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.

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

Conditions
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Impaired Dark Adaptation

Intervention / Treatment
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* Drug: QLT091001
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo (for QLT091001)<br>Placebo is supplied to mimic QLT091001 oral solution. | Other: Placebo<br>* Placebo is administered orally at multiple time points.<br>|
| Experimental: QLT091001 - first oral dose<br>Subjects will receive an oral dose of 10mg/m2 of QLT091001. | Drug: QLT091001<br>* QLT091001 administered orally at multiple time points.<br>|
| Experimental: QLT091001 - second oral dose<br>Subjects will receive an oral dose of 40 mg/m2 of QLT091001. | Drug: QLT091001<br>* QLT091001 administered orally at multiple time points.<br>|

What is the study measuring?
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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 |