The Phase II/III early-stage and late-stage retinitis pigmentosa (RP) are randomized, multi-centered, double-masked, sham-controlled studies evaluating NT-501 in 60 subjects with early-stage and late-stage RP, respectively. Visual field sensitivity and visual acuity are the primary efficacy endpoints of the early-stage and late-stage studies, respectively.
Phase II dry form of age-related macular degeneration (AMD) is a randomized, multi-centered, double-masked, sham-controlled study evaluating NT-501 in 48 subjects with dry AMD. Visual acuity is the primary efficacy endpoint of this study. All the subjects in the three studies will receive either a high or low dose NT-501 implant in one eye and a sham treatment in the other eye.
NT-501 is an intraocular, cell containing polymer implant designed to provide the continuous, long-term release of the therapeutic protein, ciliary neurotrophic factor, directly into the back of the eye by means of the company’s proprietary encapsulated cell technology.
Ted Danse, president and CEO of Neurotech, said: “This is a very significant achievement for the company and a critical milestone in the development of NT-501. We are very pleased with how quickly enrollment was completed for all three clinical studies and we anticipate announcing top-line results for these studies by the end of FY 2008.”