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J.S. Heier, J.R. Sy, E.R. McCluskey, rhuFab V Study Group; RhuFab V2 in Wet AMD – 6 Month Continued Improvement Following Multiple Intravitreal Injections . Invest. Ophthalmol. Vis. Sci. 2003;44(13):972.
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Purpose: To investigate the continued safety, tolerability, and long term biologic activity of rhuFabV2, a monoclonal antibody fragment directed against VEGF, after administration of a series of four to eight intravitreal injections to subjects with neovascular age-related macular degeneration. Methods: Open-label, randomized, controlled study of 64 subjects enrolled in 2 dose groups (300µg and 500µg every 28 days) or to ‘usual care’ (4:1 rhuFab V2:Usual Care) (4 – 8 injections total). Most usual care subjects crossed over to rhuFab V2 treatment for 12 weeks after the initial study period. Eligible subjects were enrolled into three strata: 1) minimally classic CNV (MC); 2) predominantly classic CNV (PC -a PDT-eligible lesion); or 3) an active lesion after treatment with PDT. All subjects underwent ETDRS visual acuity testing, ophthalmologic examination, fluorescein angiography, and fundus photography at baseline and during treatment and follow-up. Endpoints investigated include visual acuity, adverse events (ocular and non-ocular) and biologic activity (e.g. leakage from CNV and CNV size/characteristics) out to 6 months. Results: The first 30 subjects were randomized to treatment with 0.3 mg (25) or to usual care (5), the next 34 subjects were randomized to treatment with 0.5 mg (28) or to usual care (6). The mean age of treated subjects was 77 years (range 59-91), 52% were female and 94% were Caucasian. CNV was minimally classic in 39%, predominantly classic in 33% and 28% had had prior PDT. Preliminary data in subjects with data out to Day 210 treated with 300 ug (n=19), the average visual acuity (total number of correct letters on the ETDRS chart) improved 8.5 ± 3.3 (SE) letters from baseline at Day 98 and improved an additional 4.3 letters to a net overall improvement of 12.8 ± 3.4 letters at Day 210. Subjects in the Usual Care group in Part 1 who received 300 ug rhuFab in part 2 (and had complete data as of 11/30/02; n=4) showed a decrease of 3.0 ± 5.6 letters at Day 98 (after only usual care) but then improved by 10.3 letters to 7.3 ± 6.6 letters at Day 210 after treatment with 300 ug rhuFab. Full data will be presented. There have been few drug-related serious adverse events, and except for reversible inflammation, all subjects have tolerated the injections well. Conclusions: rhuFabV2 continued to demonstrate visual acuity improvement between the 3 month and 6 month time points. Further study is warranted.
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