Abstract
Abstract: :
Purpose: To determine if the beneficial effects of photodynamic therapy (PDT) with verteporfin (Visudyne; Novartis Ophthalmics, Duluth, GA) demonstrated in randomized clinical trials for patients with age-related macular degeneration (AMD) can be achieved in a clinic setting. Methods: Prospective, non-comparative interventional study. One eye from all patients over 50 years of age, of one physician (MJP), with subfoveal choroidal neovascularization (CNV) from AMD, treated initially between July 2000 – July 2001 was included in analysis. PDT treatment, re-treatment, and follow-up schedules were as outlined in the TAP (Treatment of AMD with PDT) Study, and ETDRS visual acuities recorded at every visit. Unlike TAP, retreatment was at the discretion of the treating physician. The primary outcome measure was loss of <15 letters (3 lines) of ETDRS acuity, with the secondary outcome measure of maintenance (change from baseline of +4 letters) or improvement (>4 letter increase) in ETDRS acuity, over 12 months. Missing data was imputed using last observation carried forward. Results: All clinic patients that met the inclusion criteria (n=74) were included in the analysis. Fifty-two patients were female (70%), 22 were male (30%), and the mean age was 77.7 years. Thirty-nine patients (52.7%) had predominantly classic (PC), 9 patients (12.2%) had minimally classic (MC), and 26 (35.1%) patients had occult with no classic CNV lesions on angiography at baseline. Mean initial ETDRS acuity was 48 letters (approximate Snellen equivalent 20/100-2). At 12 months, 53 patients (71.6%) had lost <15 letters of ETDRS acuity, and 38 patients (51.4%) had maintained or improved acuity. Mean loss was 6 letters. On subgroup analysis by lesion composition, 27 (69.2%), 8 (88.9%) and 18 (69.2%) patients lost <15 letters, and 19 (48.7%), 7(77.8%) and 12 (46.2%) patients maintained or improved ETDRS acuity, in the PC, MC, and occult with no classic CNV groups, respectively. Mean change in acuity was -6.5 letters in the PC group, -8 in the occult with no classic group, and 3.5 lines in the MC group. Mean final acuity was 42.5 letters (8.5 lines). Conclusions: Clinically favorable outcomes were observed in this series. Results from this series appear to be slightly better than those of the treated groups in the TAP and VIP trials, which may be due to differences in baseline characteristics between the two groups.
Keywords: age-related macular degeneration • photodynamic therapy • clinical (human) or epidemiologic studies: tre