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P. B. Henrich, K. B. Hatz, U. Schneider, B. Braun, S. Sacu, C. F. Pruente; Evaluation of Re-Treatment Indications in a Randomized, Double-Masked, Phase IIIb Study Comparing Ranibizumb Monotherapy With Ranibizumab + PDT Combination Therapy in Patients With Subfoveal Choroidal Neovascularisation. Invest. Ophthalmol. Vis. Sci. 2009;50(13):1904.
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To evaluate retreatment frequency and indications in a randomized controlled trial comparing Ranibizumab monotherapy with combination therapy using Ranibizumab + standard fluence PDT.
Patients were randomized to receive PDT or sham PDT, followed by 3 initial monthly 0.3mg intravitreal Lucentis injections. Over the course of the following 9 months, Ranibizumab injections were repeated if during one of the monthly visits a loss of more than 5 ETDRS letters in BCVA or an increase in central retinal thickness >100µm (OCT) were observed.
40 patients were recruited, 37 reached the endpoint at 12 months (19 in the monotherapy and 18 in the combination group). 62.2% of all patients (n=23) needed at least one retreatment throughout the course of the study, 73.7% (n=14) in the monotherapy and 50.0% (n=9) in the combination therapy treatment arm. The total number of retreatments was significantly higher in the monotherapy group (n=43) than in the combination therapy group (n=20). Mean treatment-free interval before the first reinjection was 4.3 months in the monotherapy (range 1-8) and 5.3 in the combination therapy group (range 1-9). In both groups, reinjections were mainly based on a drop in BCVA (58.1% in the monotherapy versus 55% in the combination group), to a lesser extent on OCT criteria (27.9% and 35.0%) or on both BCVA and OCT (13.9% and 10.0%, respectively).
Patients receiving monotherapy required earlier and more frequent retreatments than patients on combination therapy. In both groups most retreatments were based on a drop in BCVA.
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