Purchase this article with an account.
P.J. Rosenfeld, N. Villate, W.J. Feuer, C.A. Puliafito, E.R. McCluskey; RhuFab V2 (Anti-VEGF Antibody Fragment) in Neovascular AMD: Safety, Tolerability, and Efficacy of Multiple, Escalating Dose Intravitreal Injections . Invest. Ophthalmol. Vis. Sci. 2003;44(13):970.
Download citation file:
© ARVO (1962-2015); The Authors (2016-present)
Purpose:To investigate the safety, tolerability, and efficacy of rhuFab V2, a monoclonal antibody fragment against VEGF, when administered as a series of multiple, escalating dose intravitreal injections in eyes of patients with neovascular AMD. Methods:This phase I, multicenter, randomized trial enrolled 30 patients into three dosing regimens. All patients were treated for a total of 16 weeks and followed through 20 weeks. Group 1 received escalating doses from 300µg to 1.0mg every 2 weeks over 6 weeks followed by 1.0mg of rhuFab V2 every 4 weeks. Group 2 received escalating doses from 300µg to 2.0mg every 2 weeks over 14 weeks followed by a final 2mg dose at week 16. Group 3 received escalating doses from 300µg to 2mg every 4 weeks over 16 weeks. All patients underwent ETDRS visual acuity testing, ophthalmological examination, and adverse event assessment at each study visit, with fundus photography, fluorescein angiography, OCT, and pharmacokinetic evaluations at selected visits. Results:Twenty-one of the 30 patients were enrolled at the Bascom Palmer Eye Institute; Group1 (n=5), Group 2 (n=8), and Group 3 (n=8). The types of subfoveal CNV lesions enrolled included occult CNV with no classic CNV (n=6), minimally classic CNV (n=6), predominantly classic CNV (n=2), predominantly classic CNV after PDT (n=4), and CNV with RPE tears (n=3). Intravitreal injections as frequent as every 2 weeks were well tolerated by the patients. The most frequent adverse event was mild inflammation. Significant intraocular inflammation was not observed when rhuFab was escalated from an initial dose of 300µg to doses as high as 2mg. At week 20 (Day 140), 19 of the 21 patients (90%) had stable (± 4 letters) or improved (> 5 letters) vision with 11 patients (52%) gaining at least 3 lines (15 letters). Stable and improved visual acuity correlated well with decreased fluorescein angiographic leakage and decreased retinal thickness measured by OCT. Conclusions:The intraocular inflammation previously observed at initial doses of rhuFab V2 higher than 500µg was not observed when the dose was escalated every 2 weeks or 4 weeks from 300µg to 2mg. Regimens using frequent dosing and higher doses of rhuFab V2 were well tolerated with an apparent beneficial effect on both visual acuity and lesion appearance. The beneficial effects of rhuFab V2 were observed for all CNV lesion types enrolled.
This PDF is available to Subscribers Only