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Y TanoJAT Study Group; The Japanese AMD Trial (JAT): Preliminary Results of Verteporfin Therapy in Japanese Age-Related Macular Degeneration Patients . Invest. Ophthalmol. Vis. Sci. 2002;43(13):977.
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Purpose: To present the results of the Japanese Age-related macular degeneration (AMD) Trial (JAT), which investigated the effect and safety of verteporfin (Visudyne®, Novartis AG) therapy in Japanese patients with AMD. Methods: The study was initiated in May 2000 at five institutes in Japan. Main eligibility criteria included: subfoveal choroidal neovascularization (CNV) with a classic component, a lesion with greatest linear dimension (GLD) ≤5400 µm, and a best-corrected visual acuity letter score of 73-34 (Snellen equivalent 20/40 to 20/200). All patients received verteporfin therapy at the initial visit, and were retreated at 3-monthly follow-up visits if fluorescein leakage from CNV was seen on angiography. The primary outcome measure was the progression of fluorescein leakage from classic CNV beyond the baseline lesion area; visual acuity outcomes were also assessed. Results: Sixty-four patients were enrolled (45 men, 19 women, mean age 69 years). More than half (n=39; 61%) of the lesions were minimally classic, 16 (25%) were predominantly classic, and 9 (14%) had occult CNV with no classic CNV (based on Photograph Reading Center review). Up to the month 6 examination, a mean of 1.7 of a maximum possible 2 treatments per patient were given. Progression of fluorescein leakage from classic CNV occurred in 13 patients (20%) and from occult CNV in 20 patients (31%). The mean visual acuity letter score in the study eye was 51 (Snellen equivalent 20/100+1) at baseline compared with 53 (Snellen equivalent 20/80-2) at the month 6 examination. The mean GLD of the entire lesion was 3228 µm at baseline, while the mean GLD of the area to be retreated was 1839 µm at the month 6 examination. One patient discontinued follow-up because of a non-ocular adverse event (uremia and vascular anomaly). Acute severe vision decrease (loss of ≥20 letters of visual acuity within 7 days of treatment) was reported in two patients (3%), while no cases of photosensitivity occurred. The incidence of visual disturbances, injection-site events, and infusion-related back pain was similar to that reported in the TAP Investigation. Conclusion: These data, when compared with historical angiographic data from the TAP Investigation, suggest that the benefits of verteporfin therapy are more pronounced in Japanese than Caucasian patients with AMD. Results through the month 12 follow-up examination will be presented.
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