Abstract
Abstract: :
Purpose: To examine the effect of treatment as early as at 4-week intervals in patients with predominantly classic subfoveal CNV on the vision outcomes and number of treatments at 1 year of follow-up compared to data from the TAP Investigation. Methods: Consecutive patients presenting with a predominantly classic subfoveal CNV for treatment with PDT with verteporfin were enrolled in the analysis. Treatment criteria were similar to those used in the TAP Investigation, except patients were reviewed between 4 and 6 weeks and additional treatment applied as early as every 4 weeks if there was evidence of leakage from CNV. Snellen visual acuity was converted to logMAR for analysis. Safety analysis included visual acuity and angiographic assessment. Results: A total of 90 patients were enrolled in the analysis, of whom 64 (70%) completed the month 12 examination until today. A mean of 4.3 (median 4) treatments out of 13 possible treatments were applied, including 30 (46.9%) patients receiving more than 4 treatments. Mean (median) visual acuity at baseline was 6/26 (6/24). Mean (median) total lesion size was 1.10 (0.83) MPS disc areas. The mean (median) area of classic CNV was 0.96 (0.83) MPS disc areas. An occult component was present in 7 (10.9%) cases and haemorrhage was present in 19 (29.7%) cases. At 12-month follow-up, 20 (31.3%) patients lost at least 3 lines of visual acuity and 3 (4.7%) patients lost at least 6 lines of visual acuity. The mean change in visual acuity from baseline was -1.3 lines. No event of severe vision decrease and no additional safety concerns were noted. Vision outcomes compared to a subgroup of patients included in the TAP Investigation will be presented. Conclusions: The treatment as early as at 4-week intervals was not associated with any serious ocular adverse event or major increase in the number of treatments in the first year. Although in the absence of a control group the data have to be analysed with caution, the 4.7% rate of severe vision loss (at least 6 lines of visual acuity loss) over the first year in this study compares favorably to the 12% rate observed in patients with predominantly classic subfoveal CNV included in the TAP Investigation.
Keywords: photodynamic therapy • age-related macular degeneration • clinical (human) or epidemiologic studies: tre