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The purpose of this trial was to investigate the effect of Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in subjects suffering from age-related macular degeneration (AMD) with occult choroidal neovascularization (CNV) where fewer treatment options exist for patients with this disease form.
This study was designed as a randomized, double-blind, parallel group, placebo-controlled prospective trial. Sixty patients, 30 per treatment group, with newly diagnosed pure occult CNV defined by angiography diagnostic criteria would be enrolled. If a subject had more than one eye affected with occult CNV, the eye with the better vision as measured by visual acuity (LogMAR score) would be entered as the study eye.
Patients were randomized to receive either IGIV-C at a dose of 2 g/kg body weight over 5 consecutive days or matching placebo. Additional 2 study drug treatment courses (IGIV-C or matching placebo) were administered every 4 weeks at the same dose of 2 g/kg body weight given over 5 days. Subjects' visual acuity was measured and reported as LogMAR at screening, week 0 (baseline), day 5, week 4, week 8 and week 12. If at anytime during the study the subject's visual acuity worsened by ³ 2 lines (0.2 on the LogMAR score), then a slit lamp examination was performed and an angiogram conducted; patient discontinued if the worsening was due to some other reason outside of the occult CNV or if the disease had changed from pure occult to the classic or mixed form.
Subjects were evaluated for efficacy (LogMAR score) at endpoint (at week 12 or at last LogMAR assessment at or after week 8, if the subject prematurely discontinues the trial).
At the end of the treatment period (week 12), patients were entered into a 3 month observation period with monthly visual acuity LogMAR score assessments.
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