Primary Outcome Measures:
- - Mean change in visual acuity [LogMAR] score from baseline to endpoint compared to placebo [ Time Frame: (at week 12 or last LogMAR assessment conducted at or after week 8 of the treatment period) ]
Secondary Outcome Measures:
- Proportion of subjects who improve visual acuity from baseline to endpoint by ≥ 0.1 LogMAR. [ Time Frame: 12 Weeks ]
- Proportion of subjects who improve visual acuity from baseline to endpoint by ≥ 0.2 LogMAR. [ Time Frame: 12 Weeks ]
- Mean change in LogRAD score from baseline to endpoint (RADNER-test). [ Time Frame: 12 Weeks ]
- Proportion of subjects with an increase ≥ 2 or more points in LOCS III for nuclear opalescence, nuclear color, cortical cataract or posterior subcapsular cataract categories. [ Time Frame: 12 Weeks ]
- Presence of fibrosis and location assessed by slit-lamp. [ Time Frame: 12 Weeks ]
- Mean change from baseline to endpoint in size, type and location of lesions and leakage assessed by central fluorescein angiogram reading center. [ Time Frame: 12 Weeks ]
The purpose of this trial is to investigate the effect of IGIV-C in subjects suffering from AMD with occult CNV where fewer treatment options exist for patients with this disease form.
This study is 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 will be enrolled. If a subject has more than one eye affected with occult CNV, the eye with the better vision as measured by visual acuity (LogMAR score) will be entered as the study eye.
Patients will be randomized to receive either IGIV-C at a dose of 2 g/kg body weight (bw) over 5 consecutive days or matching placebo. Additional 2 study drug treatment courses (IGIV-C or matching placebo) will be administered every 4 weeks at the same dose of 2 g/kg bw given over 5 days. Subjects' visual acuity will be 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 worsens by ≥ 2 lines (0.2 on the LogMAR score), then a slit lamp examination will be performed and an angiogram will be conducted; the patient would be discontinued if the worsening is due to some other reason outside of the occult CNV or if the disease has changed from pure occult to the classic or mixed form.
Subjects will be 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 will be entered into a 3 month observation period with monthly visual acuity LogMAR score assessments.