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K. B. Hatz, U. Schneider, S. Sacu, B. Henrich, B. Braun, G. Fuchsjaeger, C. F. Pruente; Randomized Double-Masked Study Comparing Ranibzumab Monotherapy and PDT Combined With Ranibizumab in Patients With Exudative AMD: BCVA and Morphological Results. Invest. Ophthalmol. Vis. Sci. 2008;49(13):1170.
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To investigate the safety and efficacy of intravitreal ranibizumab monotherapy compared to intravitreal ranibizumab combined with verteporfin photodynamic therapy (PDT) in all subtypes of CNV due to AMD.
In this 1-year, phase III, monocenter, randomized, double-masked study, patients (n=40) received 3 monthly intravitreal ranibizumab (0.3mg) injections combined with either PDT (n=19) or sham PDT (n=21) at baseline. Thereafter, ranibizumab injections were repeated if disease progression was detectable based on loss >5 ETDRS letters relating to the best measured BCVA or increase of central retinal thickness by >100µm at OCT.
Mean BCVA was 52.1 letters in both groups. At 6 months BCVA significantly increased in both groups - by 11.8 in monotherapy and 7.8 letters in combination group (difference between groups not significant). Mean lesion size (fluoresceine angiography) at baseline was 9.38mm2 in monotherapy and 8.20mm2 in combination group. Mean proportion of leakage area/total area was 59.16% and 59.95%, respectively. At 6 months it significantly decreased to 10.32% and 5.67%, respectively (difference between groups not significant). 56% of monotherapy and 82% of combination patients did not show any angiographic activity at 6 months. Mean central retinal thickness at baseline was 324µm and 293µm, respectively. It significantly decreased to 231µm and 213µm (difference between groups not significant). Intraretinal edema was found by OCT in 33% and 18%, respectively, (baseline 100%), subretinal fluid in 33% and 18% (baseline 81% / 68%); pigment epithelial detachment in 28% and 12% (baseline 19% / 32%). In both groups intraretinal edema and subretinal fluid were significantly reduced.
There was a non significant trend for less beneficial BCVA outcomes in the combination group, particularly during the first 2 months following the initial treatment. Both treatments significantly reduced mean proportion of leakage area/total area, central retinal thickness, intraretinal edema and subretinal fluid while pigment epithelial detachment was slightly increased in monotherapy group and decreased in combination group. There was a non significant trend for the combination therapy to be more efficient in reducing lesion activity at 6 months. This may explain the significantly reduced need for re-treatment in the combination group (results shown elsewhere).
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