PURPOSE: To evaluate the safety and efficacy of pegaptanib sodium injection (Macugen, OSI Eyetech Pharmaceuticals) as primary therapy for previously untreated choroidal neovascular membranes (CNV) associated with wet age-related macular degeneration (AMD). METHODS: The authors retrospectively reviewed data of 90 patients with newly diagnosed wet AMD in which pegaptanib was used as primary therapy. Inclusion criteria included CNV of any angiographic subtype and size. Exclusion criteria included any lesion previously treated with photodynamic therapy (PDT), intravitreal triamcinolone, or thermal laser. Outcome measures included pre and post-treatment changes in best-corrected visual acuity, lesion size, lesion angiographic characteristics, and optical coherence tomography (OCT) measurements. Patients were injected every 6 weeks and fluorescein angiography (FA) and OCT imaging were performed after every three injections. Safety assessment was performed by complete ophthalmologic examination pre- and post-injection. RESULTS: Of the patients undergoing primary treatment with pegaptanib, the lesion characteristics were 80% (72/90) occult, 13% (12/90) minimally classic, and 7% (6/90) predominantly classic. Lesion sizes were 50% (45/90) <or=4 disc areas (DA) and 50% (45/90) >4 DA. The mean follow-up was 9.1 +/- 2 months (range 6-14 months). Gain of >or=3 lines of vision occurred in 20% (18/90) of patients, stabilization of vision (prevention of three lines of vision loss) occurred in 70% (63/90) of patients, and loss of >or=3 lines of vision occurred in 10% (9/90) of patients, resulting in a 90% response rate. In the patients who gained >or=3 lines of vision, the average number of injections was 3.5. One case of endophthalmitis was recognized. CONCLUSIONS: Pegaptanib as primary therapy for naïve CNV lesions offers a 90% rate of improvement or stabilization of vision-outcomes that exceed those reported in the VISION trial.
PURPOSE: To evaluate the safety and efficacy of pegaptanib sodium injection (Macugen, OSI Eyetech Pharmaceuticals) as primary therapy for previously untreated choroidal neovascular membranes (CNV) associated with wet age-related macular degeneration (AMD). METHODS: The authors retrospectively reviewed data of 90 patients with newly diagnosed wet AMD in which pegaptanib was used as primary therapy. Inclusion criteria included CNV of any angiographic subtype and size. Exclusion criteria included any lesion previously treated with photodynamic therapy (PDT), intravitreal triamcinolone, or thermal laser. Outcome measures included pre and post-treatment changes in best-corrected visual acuity, lesion size, lesion angiographic characteristics, and optical coherence tomography (OCT) measurements. Patients were injected every 6 weeks and fluorescein angiography (FA) and OCT imaging were performed after every three injections. Safety assessment was performed by complete ophthalmologic examination pre- and post-injection. RESULTS: Of the patients undergoing primary treatment with pegaptanib, the lesion characteristics were 80% (72/90) occult, 13% (12/90) minimally classic, and 7% (6/90) predominantly classic. Lesion sizes were 50% (45/90) <or=4 disc areas (DA) and 50% (45/90) >4 DA. The mean follow-up was 9.1 +/- 2 months (range 6-14 months). Gain of >or=3 lines of vision occurred in 20% (18/90) of patients, stabilization of vision (prevention of three lines of vision loss) occurred in 70% (63/90) of patients, and loss of >or=3 lines of vision occurred in 10% (9/90) of patients, resulting in a 90% response rate. In the patients who gained >or=3 lines of vision, the average number of injections was 3.5. One case of endophthalmitis was recognized. CONCLUSIONS:Pegaptanib as primary therapy for naïve CNV lesions offers a 90% rate of improvement or stabilization of vision-outcomes that exceed those reported in the VISION trial.