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A. N. Antoszyk, H. Shapiro, N. Shams; Long-term (3-year) Experience with LucentisTM (ranibizumab) in Patients with Neovascular Age-Related Macular Degeneration: Extension Study 2508. Invest. Ophthalmol. Vis. Sci. 2007;48(13):1810.
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Ranibizumab (LucentisTM) is a recombinant, humanized, antigen-binding antibody fragment (Fab) that binds to and neutralizes all known active forms of vascular endothelial growth factor-A (VEGF-A). Study 2508 was an open-label, noncontrolled, extension study for continued treatment with ranibizumab in patients with neovascular age-related macular degeneration (AMD) who had previously participated in 1 of 3 phase I/II trials (studies 1770–single dose, 2128–multiple dose, and 2425–escalating dose).
Patients initially received monthly intravitreal injections of ranibizumab 0.3 mg. The protocol was amended to increase the dose to 0.5 mg, and doses could be held if visual acuity (VA) and lesion characteristics were stable. Assessments included ocular and non-ocular adverse event monitoring, intraocular pressure measurement, and slit-lamp examination of study and fellow eyes. Of 70 patients enrolled (2 from 1770, 44 from 2128, and 24 from 2425), 67 were treated in the extension study for up to 3.8 years. VA was measured using Early Treatment of Diabetic Retinopathy Study charts.
The mean ± SD duration of follow-up in this extension study was 971± 400 days for all patients (174 days for study 1770, 1008 days for study 2128, and 968 days for study 2425). In the 67 treated patients, the most common ocular adverse events were conjunctival hemorrhage (20 [29.9%]), retinal hemorrhage (18 [26.9%]), and reduced visual acuity (13 [19.4%]). In the 67 treated patients, the most common non-ocular adverse events were hypertension (17 [25.4%]), nasopharyngitis (17 [25.4%]), and sinusitis (8 [11.9%]). On average, VA improvement experienced since the start of the initial studies was maintained.
Repeated intravitreal injections of ranibizumab were well tolerated for up to 3.8 years in patients with neovascular AMD.
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