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R. O. Schlingemann, U. Schmidt-Erfurth, B. Eldem, R. Guymer, on behalf of the EXCITE study group; Safety and Efficacy of Quarterly vs. Monthly Ranibizumab Injections in Patients With Neovascular Age-related Macular Degeneration: 12-months Results of the EXCITE Study. Invest. Ophthalmol. Vis. Sci. 2009;50(13):2382.
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To compare the safety and efficacy of 2 ranibizumab dosing regimens in patients with neovascular age-related macular degeneration (AMD).
In the double-masked, active-controlled, multi-center EXCITE study, AMD patients were treated either with 3 initial monthly injections (loading phase) followed by quarterly injections of 0.3 mg ranibizumab (n=120), or with a loading phase and quarterly injections of 0.5 mg ranibizumab (n=118), or with monthly injections of 0.3 mg ranibizumab (n=115). Best-corrected visual acuity (BCVA) was assessed monthly using Early Treatment for Diabetic Retinopathy Study charts.
The most frequent adverse events (AEs) in all treatment groups were eye pain (11.9-20.9%) and conjunctival hemorrhage (10.4-19.2%) for ocular AEs and hypertension (5.1-8.3%) and nasopharyngitis (3.4-9.2%) for non-ocular AEs. The most frequent serious AEs were retinal pigment epithelial tear (0.5 mg quarterly n=2) and atrial fibrillation (0.5 quarterly and 0.3 monthly n=2 each). In patients treated per protocol, the mean BCVA increased from baseline to Month 12 (primary efficacy endpoint) by 4.9 letters in the 0.3 mg quarterly (n=104), 3.8 letters in the 0.5 mg quarterly (n=88), and 8.3 letters in the 0.3 mg monthly treatment groups (n=101). Monthly treatment resulted in a significant increase in BCVA of 3.3 letters over the BCVA gain in the quarterly treatment groups (pooled quarterly doses) at Month 12. Mean BCVA gain between Months 3 and 12 was significantly higher in the monthly treatment group (+0.8 letters) compared to quarterly treatment groups (-1.8 letters for 0.3 mg, -2.8 letters for 0.5 mg).
Safety and efficacy results were consistent with previous pivotal clinical studies with ranibizumab. Although BCVA gain was observed in all ranibizumab treatment groups, initial BCVA gain was maintained on average with monthly dosing only.
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