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Clement K. Chan, Prema Abraham, David Sarraf, Asha S. Nuthi, Steven G. Lin, Colin A. McCannel, Sharon McCaffery-Theodore; High versus Conventional-dose Ranibizumab for Treating Vascularized Pigment Epithelial Detachments Associated with Age-related Macular Degeneration. Invest. Ophthalmol. Vis. Sci. 2011;52(14):1654.
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To study the efficacy and safety of 2.0 mg vs. 0.5 mg ranibizumab injections (RI), and monthly vs PRN reinjection protocol, for vascularized pigment epithelial detachments (vPED) due to AMD.
In this prospective, randomized trial the RI groups were: 1) 0.5 mg monthly (QM) x12 months (M), 2) 0.5 mg QM x 4 M followed by PRN injections to 12 M, 3) 2.0 mg QM x12 M, 4) 2.0 mg QM x 4 M followed by PRN injections to 12 M. Primary outcome measures were pre- and post-RI (last visit) vision. Secondary outcome measures were pre- and post central-1mm thickness; area (A2), greatest diameter (GLD), & heights of PED and choroidal neovascularization (CNV); subretinal fluid (SRF) and cystoid macular edema (CME); adverse events. Baseline and follow-up best corrected ETDRS VA in letters scores, fundus and fluorescein images, biomicroscopy, & OCT were performed to a set schedule. Statistical analyses were done with Wilcoxon Signed Rank, Mann-Whitney, and Fisher 2-tailed tests.
From 2008 to 2010, 27 eyes in 27 subjects, 19 women, were enrolled with a mean age of 79.1 yrs, and mean follow-up of 8.9 M. Mean pre and post-RI VA of entire cohort were 52.8 ±11.7 (20/90) and 59.4±19.9 (20/64), p=0.17. There were no significant differences in results of QM vs PRN 0.5 mg eyes for all variables, and QM vs PRN 2.0 mg eyes. In assessing all 0.5 mg eyes, there was significant decrease in pre and post-RI vPED height, central 1-mm, vPED A2 and GLD, SRF,and CME (p=0.01,0.003, 0.001, 0.003, 0.002, 0.003).The same was true for analysis of all pre and post-RI 2.0 mg eyes (p=0.003, 0.01, 0.02, 0.03, 0.004), with exception of CME. Comparison of the above post-RI variables between all 0.5 mg and all 2.0mg eyes showed no significant differences (p=0.15, 0.51, 0.08, 0.17, 0.92, 0.57). However, there were greater decrease in PED height, SRF, vPED A2 early in the study (Weeks 4 and 8) for 2.0 mg eyes compared to 0.5 mg eyes (p=0.02, 0.01, 0.03). vPED consistently flattened in 2.0 mg eyes but not in 0.5 mg eyes (p=0.01). One eye each (0.5 mg PRN) formed an RPE tear and worse cataract (0.5mg QM).
2.0 mg ranibizumab was more effective than 0.5 mg in reducing dimensions of vPED much earlier in the study. In contrast to 0.5 mg, 2.0 mg ranibizumab consistently flattened the vPED. Both doses were associated with a sound safety profile.
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