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

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.

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.

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