The initiation of a Phase IIa clinical study of a novel synthetic form of 11-cis retinal (“QLT091001”) has been announced by the experimental drug’s sponsor, QLT Inc., of Vancouver (TSX: QLT; NASDAQ:QLTI). The single-blind, placebo-controlled, proof-of-concept trial (NCT01999764, Clincialtrials.gov Identifier) will be an interventional randomized study designed to evaluate the treatment effects of two different oral doses (10 and 40 mg/m2) of the synthetic retinoid weekly for 3 weeks in patients with impaired dark adaptation. The study aims to recruit approximately 40 patients over the age of 60 years with early age-related macular degeneration (AMD) based on LLLC BCVA (low luminance low contrast best-corrected visual acuity) criterion or evidence of impaired dark adaptation. The study will be conducted across 7 centers in the US and has an estimated primary completion date of April 2014.
Phase IIa study of a synthetic retinoid to treat impaired dark adaption is initiated in the US.
- by swdadmin