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JS Heier, WL GreenerhuFabV Study Group; rhuFabV2 (an Anti-VEGF Antibody Fragment) in Neovascular AMD: Safety and Tolerability of Multiple Intravitreal Injections . Invest. Ophthalmol. Vis. Sci. 2002;43(13):2520.
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Purpose: To investigate the safety, tolerability, and biologic activity of rhuFabV2, a monoclonal antibody fragment directed against VEGF, when administered as a series of four intravitreal injections to subjects with neovascular AMD. Methods: Open-label, randomized, controlled study. Up to 60 subjects will be enrolled (4:1 rhuFab V2:Usual Care) in up to 2 dose groups: 300mg and 500mg every 28 days (4 injections total). Subjects may cross over to Usual Care or rhuFab V2 treatment for 12 weeks after the initial study period. Eligible subjects have one of the three following characteristics: 1) predominately occult CNV with some amount of classic; 2) a PDT-eligible lesion (predominately classic subfoveal CNV); or 3) an active lesion after treatment with PDT. All subjects undergo 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 markers of biologic activity such as change in leakage from CNV and CNV size/characteristics. Results: As of 12/5/01, the 300mg dose group has been enrolled (30 subjects total). Overall, mean subject age is 73, 100% are Caucasian, and 45% are female. CNV was predominately classic in 8/30 (27%) of subjects, predominately occult in 14/30 (46%), and post-PDT in 8/30 (27%). Baseline visual acuity ranged from 20/50 to 20/500, with a median of 20/125. There have been no drug-related serious adverse events, and all subjects tolerated the injections. Conclusion: rhuFabV2 at a monthly dose of 300mg has been tolerated in this Phase Ib/II study, and rhuFabV2 is undergoing further evaluation in the management of subfoveal CNV.
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