QLT091001 in Impaired Dark Adaptation
Evaluation of the Effects of Oral QLT091001 in Adults with Impaired Dark Adaptation (IDA)
Impaired Dark Adaptation (IDA) is a condition that results in decreased ability of the eye to recover visual sensitivity in the dark following exposure to bright lights (photobleaching) that gets worse with age. Profoundly impaired dark adaptation is commonly associated with inherited retinal degenerations. IDA may occur due to age-related inefficiencies in the retinoid cycle which results in slower regeneration of the light sensing pigment 11-cis-retinal in the eye and increased levels of free unbound opsin that lead to delayed dark adaptation and reduced retinal sensitivity.
In late 2013, we initiated a Phase IIa proof-of-concept randomized, multi-center, parallel-group, placebo-controlled study of QLT091001 in adult (age 60 or older) patients with IDA or impaired low luminance low contrast (LLLC) best-corrected visual acuity (BCVA) in at least one eye and having no known ophthalmic pathologies to explain their condition other than early age-related macular degeneration (AMD). The trial, designed to evaluate the safety profile and effects of QLT091001 on impared dark adaptation time, glare recovery time and LLLC BCVA, was completed and results were reported on December 5, 2014. Forty-three patients were randomized to receive placebo or one of two different doses (10 or 40 mg/m2) of QLT091001 once per week for three consecutive weeks with one additional dose the day after the third dose, with four weeks of follow-up.
Patients treated with QLT091001 showed trends to improvement in dark adaptation time and glare recovery time relative to patients treated with placebo.
For more information, visit ClinicalTrials.gov.
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QLT Medical Information
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