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A.A. Okada, Y. Matsumoto, F. Shiraga, S. Komemushi, S. Yamamoto, A. Obana, M. Yuzawa, T. Hida, Japan TTT Research Group; Japan TTT for CNV in AMD (JTCA) Study: Preliminary Report . Invest. Ophthalmol. Vis. Sci. 2006;47(13):374.
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To investigate the safety and efficacy of transpupillary thermotherapy (TTT) for the treatment of subfoveal choroidal neovascularization (CNV) in age–related macular degeneration (AMD).
After informed consent, 99 patients with subfoveal CNV associated with AMD were enrolled between January 2002 and January 2004 from 20 university hospitals in this institutional review board–approved double–masked prospective study. Entry criteria included patient age 50 years or greater, best–corrected visual acuity 0.05 to 0.5, 50% or greater occult type CNV, CNV greatest linear dimension within 3 disc diameters, and presence of subretinal fluid in the fovea documented by optical coherence tomography (OCT). Only one eye per patient was eligible. Patients were randomized to receive one of two doses (high or low) of TTT at entry and, at the treating physician’s discretion, at 3 months.
There was an approximately 15% follow–up incompletion rate for each group. Preliminary analysis showed no statistically significant difference in ETDRS visual acuity and rate of lesion fibrosis by examination of color fundus photographs over a 1–year period. There was a significantly increased rate of improvement in fluorescein angiographic leakage at 6 months in the high dose group, but this difference was lost at 1 year. No difference was detected in OCT improvement between the two groups.
Preliminary analysis failed to show an advantage of high dose TTT over low dose TTT in the treatment of subfoveal CNV in Japanese AMD eyes. Poor enrollment and a high dropout rate limited the utility of this study.
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