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R. Y. Kim, S. Francom, L. Tuomi, L. Scott; Cataract Development after Intravitreal Ranibizumab Injection for Wet Age-related Macular Degeneration (AMD). Invest. Ophthalmol. Vis. Sci. 2009;50(13):727.
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Causality between treatment of wet AMD and the development of cataracts has been suggested in the literature. To evaluate this association in an appropriately controlled clinical trial setting, we performed a review of results from 4 randomized, single- (FOCUS) and double-masked (MARINA, ANCHOR, and PIER), controlled trials of intravitreal ranibizumab injection for wet AMD.
MARINA (n=477) and ANCHOR (n=277) evaluated monthly 0.3 mg or 0.5 mg of ranibizumab versus sham or verteporfin PDT, respectively. PIER (n=120) studied both doses of ranibizumab versus sham with less frequent dosing after an initial 3 monthly injections. FOCUS (n=105) evaluated the 0.5 mg dose in combination with verteporfin PDT versus PDT alone. Patients in each trial were randomly assigned to one of the treatment arms. Cataracts were reported on adverse event case report forms.
The incidence of cataract adverse events over 2 years was reviewed (1 year data was used for PIER due to cross-over of the sham subjects). In MARINA the rates were 15.7% (37/236) in the sham group, 15.5% (37/238) in the 0.3 mg group, and 15.5% (37/239) in the 0.5 mg group. In ANCHOR the rates were 10.5% (15/143) in the PDT group, 16.8% (23/137) in the 0.3 mg group, and 20.0% (28/140) in the 0.5 mg group (p=0.03 for 0.5 mg vs. PDT and p=0.12 for 0.3 mg vs. PDT). In FOCUS the rates were 19.6% (11/56) in the PDT group and 20.0% (21/105) in the 0.5 mg+PDT group. In PIER the 1 year results were 6.5% (4/62) in the sham group, 5.1% (3/59) in the 0.3 mg group, and 11.5% (7/61) in the 0.5 mg group.
A review of data from these 4 trials revealed inconsistent results. There were no differences between ranibizumab groups and control in MARINA or FOCUS, and there were small differences in PIER. In ANCHOR there were higher rates for ranibizumab vs. control, although overall, in this review of multiple studies, there was inconclusive evidence for a difference between the ranibizumab groups and control.
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