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R. H. Guymer, R. O. Schlingemann, R. Axer-Siegel, B. Eldem, on behalf of the EXCITE study group; Corneal Endothelial Cell Density in Patients With Neovascular Age-related Macular Degeneration Treated With Ranibizumab in the EXCITE Study. Invest. Ophthalmol. Vis. Sci. 2009;50(13):2367.
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To explore the effect of ranibizumab treatment over 12 months on corneal endothelial cell (CEC) density in patients with neovascular age-related macular degeneration (AMD).
In the double-masked, active-controlled, multi-center EXCITE study AMD patients with predominantly classic, minimally classic, or occult lesions without classic component were randomized into 3 treatment arms: (1) 3 initial monthly injections (loading phase) followed by quarterly injections of 0.3 mg ranibizumab (n=120), (2) loading phase and quarterly injections of 0.5 mg ranibizumab (n=118), and (3) monthly 0.3 mg ranibizumab injections (n=115). The change of CEC density from baseline to Month 12 was determined by non-contact specular microscopy. The 12-months CEC density data were adjusted for age-related yearly cell loss of 0.6%. In the analysis only patients who had ≥2000 CEC/mm2 at baseline were included.
Baseline mean values for all 3 treatment groups were within the range of 2414-2561 CEC/mm2. Compared to baseline, the mean CEC density at Month 12 increased by 11 CEC/mm2 in the 0.5 mg quarterly group (n=19) and decreased by 15 and 55 CEC/mm2 in the 0.3 mg quarterly (n=20) and 0.3 mg monthly (n=20) treatment groups, respectively. In both 0.3 mg treatment groups, 20% of patients lost >10% CEC from baseline to Month 12 whereas 11% of patients did so in the 0.5 mg quarterly treatment group.
Based on the CEC density analysis of EXCITE patients, there is no consistent signal toward an increased risk for patients to lose CEC when treated with ranibizumab (monthly and quarterly dosing) over 12 months.
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