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

Completed · Phase 2 · Has a placebo group

Conditions studied: Impaired Dark Adaptation

In brief

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

Key facts

Study ID

NCT01999764

Run by

QLT Inc.

People needed

43

Starts

2013-11-01

Expected to finish

2014-07-01

Last updated by the study team

2015-07-14

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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