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J.S. Heier, P.J. Rosenfeld, A.N. Antoszyk, G. Hantsbarger, R. Kim, N. Shams; Long–Term Experience With LucentisTM (Ranibizumab) in Patients With Neovascular Age–Related Macular Degeneration (AMD) . Invest. Ophthalmol. Vis. Sci. 2005;46(13):1393.
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Purpose: To observe the long–term safety and visual benefit of patients receiving extended treatment, often with a reduced frequency of administration, of intravitreal ranibizumab for subfoveal choroidal neovascularization secondary to age–related macular degeneration. Methods: Subjects who lost <15 letters at the end of the phase I/II studies could continue on ranibizumab in the study eye in an open–label extension study. Approximately 94% of subjects were eligible. Of 70 subjects enrolled, 66 received at least 1 ranibizumab injection. By protocol amendment, the initial dose of 0.3 mg was increased to 0.5 mg, and the fixed dosing interval of every 4 weeks was changed to a more flexible strategy of holding a dose if VA was stable (change of <5 letters) and lesion characteristics were stable on 2 consecutive visits. Results: Safety and VA data to April 15, 2004 have been analyzed. Median follow–up was 415 days (range, 70–589 days). Prior to the amendment, the median rate of dosing was 1.0 injections every 4 weeks. Afterwards, the median rate decreased to 0.22 injections every 4 weeks. Visual acuity showed no overall declines during the study, either before or after the amendment. Ranibizumabcontinued to be well tolerated. The most common adverse events of the study eye were conjunctival hemorrhage (29% of treated patients), eye pain (11%), blurred vision (11%), iris and uveal tract inflammations (11%), and increased intraocular pressure (11%). All but one of these events were mild or moderate in severity. The most common nonocular adverse events were mild nasopharyngitis (12%) and mild increased blood pressure (14%). Conclusions: After >1 year of extended follow–up, subjects receiving ranibizumab had stable VA and stable lesion characteristics despite a reduced frequency of injections. The ongoing PIER study is testing a less frequent dosing strategy in patients with neovascular AMD.
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