Pegaptanib sodium treatment in neovascular age-related macular degeneration: clinical experience in Germany

Abstract

BackgroundThe VEGF Inhibition Study In Ocular Neovascularisation (VISION) reported the efficacy of intravitreal (ITV) vascular endothelial growth factor (VEGF) inhibition with pegaptanib sodium (Macugen®) for the treatment of neovascular age-related macular degeneration (AMD). This paper reports clinical experience with pegaptanib sodium for the treatment of occult or minimally classic choroidal neovascularization (CNV) due to AMD.Material and methodsThe study included 50 eyes (in 49 patients) with either occult CNV or minimally classic CNV secondary to neovascular AMD who were not eligible for photodynamic therapy (PDT). Study data were analyzed retrospectively. During the 6-month study, patients were administered an average 2.74 injections of 0.3 mg ITV pegaptanib sodium. Angiography and optical coherence tomography (OCT) examinations were carried out and intraocular pressure (IOP) and visual acuity (VA) were measured at baseline, at 3 months and at 6 months. An eye examination was performed and VA was measured the 2 days following treatment and then again at weeks 4–6, and at 3 and 6 months. OCT, VA, and IOP were also assessed at 1 month.ResultsITV pegaptanib sodium was well tolerated and no treatment complications arose. Mean VA was measured as: 0.37 ± 0.24 at baseline; 0.37 ± 0.25 at 1 month; 0.37 ± 0.25 at 3 months and 0.40 ± 0.26 at 6 months. VA was stabilized in approximately 90% of eyes treated with pegaptanib sodium. OCT examination showed a minimal change in central retinal thickness (CRT) during the course of the study, from 251.19 μm at baseline to 251.63 μm at 6 months. No elevation in IOP was measured during treatment at 4–6 months in patients receiving pegaptanib sodium.ConclusionsITV therapy with pegaptanib sodium for occult and minimally classic CNV secondary to neovascular AMD offered good efficacy with a favorable adverse events profile. The majority of patients showed stabilization in all assessed parameters. In clinical practice, careful consideration should be given to the use of nonselective VEGF inhibition in patients with a high cardiovascular risk profile or in those with a history of thromboembolic events.

Changes in the foveal microstructure after intravitreal bevacizumab application in patients with retinal vascular disease

“…There were no significant complications after intravitreal bevacizumab, including endophthalmitis, retinal detachment, cataract formation, increased intraocular pressure, or retinal artery occlusion. The presented results are in accordance with previous observations 38. Several multicenter clinical trials also did not detect any elevated incidence of severe side effects in anti-VEGF therapy; and reports on increased intraocular pressure and ischemia are seldom, with no adverse event rate exceeding 0.21% 39–45.…”

Cytokines in neovascular age-related macular degeneration: fundamentals of targeted combination therapy

“…An anti-VEGF aptamer, pegaptanib sodium (Macugen, Eyetech Pharmaceuticals/Pfizer, New York) was the first anti-VEGF-A 165 isoform aptamer FDA-licensed for treatment of neovascular-AMD, but the drug has been removed from the market by the commercial provider 9. The humanised monoclonal antibody (mAb) bevacizumab (Avastin, Genentech/Roche, San Francisco) binds to and neutralises all human VEGF-A isoforms, with an affinity superior to that of the original antibody, but does not neutralise other members of the VEGF family.…”

Anti VEGF Agents for Age Related Macular Degeneration

“…The safety profile of the drug is not less important. The Macugen was proven to be safe in the VISION study as well as in the smaller study by N. Feucht et al [19]; in both studies no relevant systemic or ocular adverse effects were noted. Cardiovascular incidents and overall mortality in the Pegaptanib sodium group were comparable to those of the sham injection group.…”