Abstract
Abstract: :
Purpose: To present the preliminary results of the quantitative method used to evaluate the treatment effect of photodynamic therapy (PDT) with verteporfin (Visudyne®, Novartis AG, Switzerland) on iris neovascularisation (NVI) in a single-centre, open-label, intra-individual controlled, dose-finding phase I/II study. Methods: A semi-quantitative global score for neovascular regression and the programme EPCO, a quantitive, planimetric analysis programme, were applied to analyse changes in iris fluorescein angiography (FLA) performed before PDT treatment and at follow-up visits. After the standard verteporfin infusion, two opposite iris quadrants were illuminated with different energy. The first group (3 patients) received 12.5/25 J/cm2, the second group (currently 2 patients) received 50/75 J/cm2. Hyperfluorescence refers to leakage from from NVI at the early phase of FLA. The EPCO programme evaluates the hyperfluorescence area in percent of total area of iris. EPCO data were compared with a qualitative global score of hyperfluorescence assessed by two independent graders. Results:The area of hyperfluorescence was 7.0% 2.8% (range 2.4% to 10.0%) before the treatment and 5.7% 3.3% (0.9% to 9.5%) of the total area of iris, at the Week 1 timepoint. The sensitivity of EPCO programme appears to be better than the subjective assessment. There was a correlation between the results of the EPCO programme and the global score in the second group of patients while there was a difference in results obtained by the 2 methods for the first group of patients treated. Additional data will be presented at ARVO. Conclusion: Initial evidence was obtained to show that EPCO may allow a sensitive evaluation of change of NVI not only for PCO and may also be used for the evaluation of fluorescein angiograms of disorders of the anterior segment, such as NVI.
Keywords: 355 clinical (human) or epidemiologic studies: risk factor assessment • 516 photodynamic therapy • 318 anterior segment