Ronald Gentile, M.D.
To evaluate efficacy of rhuFabV2 in subjects with minimally classic or occult subfoveal neovascular age-related macular degeneration.
Patients of either gender, aged 50 years or above, diagnosed with occult or minimally classic subfoveal CNV secondary to AMD and with best corrected visual acuity of 20/40 to 20/320 in the absence of subfoveal atrophy or scarring in the study eye, and better or equal to 20/800 in the fellow eye.
The MARINA and ANCHOR clinical trials met the primary efficacy endpoint of maintaining vision (defined as a loss of less than 15 letters in visual acuity) at one year in patients with wet AMD. In these studies, nearly all patients (approximately 95 percent) treated with LUCENTIS maintained or improved vision at one year compared with 62 percent of patients in the MARINA control group and 64 percent of patients in the ANCHOR control group. Importantly, up to 40 percent of patients experienced an improvement in vision of three lines (15 letters) or more on the study eye chart compared with 5 percent and 6 percent of patients in the MARINA and ANCHOR control groups, respectively. The improvement in visual acuity endpoints among patients treated with LUCENTIS in the MARINA study was maintained at year two, while patients in the control group continued to decline.
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