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G. A. Williams, W. Tao; A Phase II Study of Encapsulated CNTF Secreting Cell Implant (NT-501) in Patients With Visual Acuity Impairment Associated With Atrophic Macular Degeneration. Invest. Ophthalmol. Vis. Sci. 2009;50(13):5003.
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Currently, no effective treatment is available for vision loss associated with dry AMD, a disease of degenerative cone photoreceptors. NT-501 has shown potential efficacy in a phase I trial in patients with late-stage RP indicating a rescuing effect of CNTF on cone photoreceptors. The present study is to evaluate the safety and efficacy of NT-501 in a multi-center, double-masked, controlled, dose-ranging and randomized phase II trial for dry AMD.
The objective of this study is to explore the effect of the NT-501 implant on vision loss associated with atrophic macular degeneration. The study consists of 48 participants who were randomized to the higher or lower CNTF output implant, or to sham surgery in a 2:1:1 ratio. The primary endpoint is visual acuity at 12 months post implantation. Patients will be followed for an additional 6 months. This study will allow information to develop the safety profile of the implant, and allow the evaluation of primary and secondary efficacy outcomes that may be used in future studies.
To date, the results obtained from implanted subjects suggest that the NT-501 implant and the implant procedure are well tolerated and safe. The study will be unmasked when the last patient completes the 12-month followup. The primary and secondary efficacy results will be presented.
Full results for this study for the primary efficacy outcome measurement will be available in early 2009. If NT-501 proves to be safe and effective, it will be among the first treatments for dry AMD. The data will serve as the foundation for designing phase III studies of NT-501 in dry AMD.
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