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K. B. Hatz, U. Schneider, B. Braun, P. B. Henrich, S. Sacu, G. Fuchsjaeger-Mayrl, C. F. Pruente; Comparing Ranibizumab Monotherapy and Ranibizumab Combined With Verteporfin Photodynamic Therapy in Neovascular Age-Related Macular Degeneration: 1-Year Fluoresceine Angiographic and OCT Results. Invest. Ophthalmol. Vis. Sci. 2009;50(13):1923.
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© ARVO (1962-2015); The Authors (2016-present)
To investigate the morphological responses to ranibizumab monotherapy and ranibizumab combined with verteporfin photodynamic therapy in neovascular age-related macular degeneration (AMD).
In this 1-year, phase IIIb, 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 of more than 5 ETDRS letters relating to the best measured BCVA-score or increase of central retinal thickness (CRT) by >100µm at OCT.
Fluoresceine angiographic evaluations revealed a significant decrease of mean leakage area in both treatment groups from 5.8mm2 (monotherapy) and 5.0mm2 (combination) at baseline to 0.6 and 0.5mm2, respectively, at 12 months. Mean proportion of leakage area/total area was 59.2 and 59.9%, respectively, at baseline. At 12 months it significantly decreased to 7.8 and 5.2%. 74% of monotherapy patients and 83% of combination patients showed no angiographic activity at 12 months. Mean total lesion size was reduced from 9.4mm2 at baseline to 8mm2 at 12 months in the monotherapy group and showed a slight trend to be increased (8.2mm2 baseline, 8.5mm2 12 months) in the combination group. Mean CRT at baseline was 324 and 293µm, respectively, which significantly decreased to 227 and 200µm at 12 months. In 26 and 22% of treated eyes, respectively, intraretinal cysts were found at OCT at 12 months (baseline 100% in both groups); subretinal fluid in 47 and 28% (baseline 81/68%); pigment epithelial detachment (PED) in 37 and 0% (19/32%); sub- and intraretinal haemorrhages in 16 and 11% (62/42%); hard exudates in 5 and 0% (14/11%). In both groups intraretinal cysts, subretinal fluid and sub- and intraretinal small haemorrhages were significantly reduced.
Both treatment strategies significantly reduced leakage area, CRT, intraretinal cysts, subretinal fluid, sub-/intraretinal haemorrhages and hard exudates. There was a non significant trend for the combination approach to be more efficient in reducing lesion activity (mean proportion of leakage area/total area; patients without angiographic activity, PED) at 12 months. This may explain the significantly reduced need for re-treatment in the combination group (results shown elsewhere).
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