Enrollment complete for three trials evaluating an intraocular implant for retinal diseases

LINCOLN, R.I. — Enrollment has been completed for three clinical studies evaluating an intraocular implant, NT-501, for treating patients with early- and late-stage retinitis pigmentosa and dry age-related macular degeneration, Neurotech Pharmaceuticals, the device's developer, announced in a press release.

NT-501 is a cell-containing polymer implant designed to provide continuous, long-term release of the protein ciliary neurotrophic factor using Neurotech's proprietary Encapsulated Cell Technology, according to the release.

All three studies are randomized, multi-centered, double-masked, sham-controlled trials.

Specifically, investigators are conducting a phase 2/3 study involving 60 patients with early stage retinitis pigmentosa. Patients will receive either a high- or low-dose NT-501 implant in one eye and a sham treatment in the fellow eye. Investigators will primarily evaluate the treatment's efficacy for increasing visual field sensitivity. The same parameters will be used in the phase 2/3 study involving late-stage retinitis pigmentosa. However, investigators will also evaluate the device's effect on visual acuity, according to the release.

In the phase 2 study of dry AMD, investigators are evaluating changes in visual acuity among 48 patients treated with either a high- or low-dose NT-501 implant or sham in one eye only.

"This is a very significant achievement for the company and a critical milestone in the development of NT-501," said Ted Danse, Neurotech president and CEO, in the release. "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 [fiscal year] 2008."