Abstract
Abstract: :
Purpose: To present 2–year results of JAT, investigating the effect and safety of verteporfin (Visudyne®, Novartis AG) therapy in Japanese patients with AMD. Methods: Fifty–one of the 61 patients who completed the 12–month JAT Study enrolled in the extension. Main eligibility criteria for JAT were classic–containing subfoveal CNV, a lesion with greatest linear dimension ≤5400 µm, and a best–corrected visual acuity letter score of 73–34 (Snellen equivalent 20/40 to 20/200). Patients who completed the JAT month 12 examination and enrolled in the extension received additional verteporfin therapy at 3–monthly visits through 21 months if fluorescein leakage from CNV was seen on angiography; they were followed up through 24 months. The primary outcome was safety, assessed through visual acuity outcomes, and ocular and systemic adverse events. Results: Of 51 patients enrolled in the extension, 46 (90%) completed the month 24 examination. Five (10%) discontinued follow–up because of serious adverse events not judged to be associated with the study medication. Patients received a mean of 3.0 treatments during the first 12 months of the trial and 0.9 treatments during the second 12 months. Mean visual acuity letter score in the study eye was 50.8 at baseline and 54.2 at month 12 (Snellen equivalent 20/80–1). For the 46 patients who completed the month 24 examination, mean visual acuity score in the study eye at month 24 was 54.0 (Snellen equivalent 20/80–1). At month 24, 6 of 46 patients (13%) had lost ≥15 letters, and, of those six patients, 4 (9%) had lost ≥30 letters. The incidence of visual disturbances, injection–site events, and infusion–related back pain was similar to the 12–month results. Conclusions: The 24–month JAT results confirm the observations from 12 months and support the long–term use of verteporfin therapy to treat subfoveal CNV due to AMD in the Japanese population.
Keywords: age–related macular degeneration • choroid: neovascularization • photodynamic therapy