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Ciliary neurotrophic factor delivered by encapsulatedcell intraocular implants for treatment of geographicatrophy in age-related macular degeneration

Kang Zhanga,b,1, Jill J. Hopkinsc, Jeffrey S. Heierd, David G. Birche, Lawrence S. Halperinf, Thomas A. Albinig,
David M. Brownh, Glenn J. Jaffei, Weng Taoj, and George A. Williamsk aShiley Eye Center and Institute for Genomic Medicine, University of California at San Diego, La Jolla, CA 92093; bMolecular Medicine Research Center and
Department of Ophthalmology, West China Hospital, Sichuan University, Chengdu 610041, China; cRetina-Vitreous Associates Medical Group, Los Angeles, CA 90017; dOphthalmic Consultants of Boston, Boston, MA 02114; eRetina Foundation of the Southwest, Dallas, TX 75231; fRetina Group of Florida, Ft. Lauderdale, FL 33334; gBascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, FL 33136; hTexas Medical Center Office,
Vitreoretinal Consultants, Houston, TX 77030; iDuke University Eye Center, Durham, NC 27710; jNeurotech USA, Lincoln, RI 02865; and kBeaumont Eye Institute, Royale Oak, MI 48073

Edited* by Xiaodong Wang, University of Texas Southwestern Medical Center, Dallas, TX, and approved March 8, 2011 (received for review December
17, 2010)

There is no treatment available for vision loss associated with advanced dry age-related macular degeneration (AMD) or geographic atrophy (GA). In a pilot, proof of concept phase 2 study, we evaluated ciliary neurotrophic factor (CNTF) delivered via an intraocular encapsulated cell technology implant for the treatment of GA. We designed a multicenter, 1-y, double-masked, sham-controlled doseranging study. Patients with GA were randomly assigned to receive a high-or low-dose implant or sham surgery. The primary endpoint was the change in best corrected visual acuity (BCVA) at 12 mo.CNTF treatment resulted in a dose-dependent increase in retinal thickness. This change was followed by visual acuity stabilization (loss of less than 15 letters) in the high-dose group (96.3%) compared with low-dose (83.3%) and sham (75%) group. A subgroup analysis of those with baseline BCVA at 20/63 or better revealed that 100% of patients in the high-dose group lost <15 letters compared with 55.6% in the combined low-dose/sham group (P =
0.033). There was a 0.8 mean letter gain in the high-dose group compared with a 9.7 mean letter loss in the combined low-dose/sham group (P = 0.0315). Both the implant and the implant procedure were well-tolerated. These findings suggest that CNTF delivered by the encapsulated cell technology implant appears to slow the progression of vision loss in GA, especially in eyes with 20/63 or better vision at baseline.

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