Purpose: To explore the efficacy and safety of pegaptanib sodium as maintenance therapy in Japanese patients with neovascular, age-related macular degeneration (AMD) after induction therapy (LEVEL-J study). Methods: A multi-center, prospective study was conducted at 21 medical institutions between 2009 and 2011. Of Japanese neovascular AMD patients with choroidal neovascularization who showed improvement in visual acuity (VA) with induction therapy, those who were scheduled for intravitreal injections of pegaptanib as maintenance therapy were recruited. LogMAR VA was assessed. Booster treatment (unscheduled treatment with other agents) was allowed during the study period if symptoms were judged to have worsened. Safety was assessed by monitoring adverse events and intraocular pressure (IOP). Results: Of 75 patients included in the analysis, 80 % completed the 54-week study period. Their mean age was 74.7 ± 6.9 years, and 54 patients (72.0 %) were men. The mean number of pegaptanib injections was 5.7 ± 2.6. Booster treatment was not required in 40 eyes (53.3 %). Mean logMAR VA was 0.61 ± 0.31 before induction therapy, 0.26 ± 0.24 before maintenance therapy, and 0.29 ± 0.28 at 54 weeks. No notable change in VA was observed during maintenance therapy. Adverse events were reported in 4 patients (5.3 %), including increased intraocular pressure, cancer, gallstones and recurrence of breast cancer, but mean IOP remained stable during maintenance therapy. Conclusions: The results of this exploratory study suggest that maintenance therapy with pegaptanib is potentially an effective and well-tolerated option in Japanese patients with neovascular AMD in whom induction therapy has been successful.
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