Objective: To determine the safety and efficacy of verteporfin (visudyne) photodynamic therapy in age-related macular degeneration patients with subfoveal predominant choroidal neovascularization in China.
Methods: Multicenter, open-label, non-controlled clinical study. The included patients are diagnosed AMD patients with predominant classic CNV. The included patients received verteporfin intravenously followed by 689 nm laser light administration 15 minutes after the infusion start. The patients were be followed up for 24 weeks (+/-12 days) after initial verteporfin PDT treatment. Clinical follow-up was done at the end of week 12 (+/-12 days) and week 24 (+/-12 days) after the initial treatment. Additional treatment was given after 12 weeks from initial treatment if leakage from CNV was observed on fundus fluorescein angiogram. The visual acuity with ETDRS visual chart and the retinal lesion changes were documented and compared with baseline. The adverse events both in the process of treatment and in the follow-up were recorded throughout the entire study period.
Results: Thirty-one patients (31 eyes) were included and completed the trial with verteporfin PDT treatment. During the 24 weeks of the trial, 38.7% of the treated eyes had a vision gain more than 5 letters, 83.9% of the treated eyes had less than 15 letters vision loss. At week 12 after the initial treatment, 12.9% of the treated eyes had no leakage; 61.3% of the treated eyes had leakages, but limited to the former lesion, 25.8% of the treated eyes had increased leakage. The results at week 24 after the initial treatment were similar to those at week 12. At week 24 after the initial treatment, there were only slight enlargements in the lesion size, area of retinal lesion, the lesion surrounding area, and greatest linear dimension (GLD) of the lesion, but no statistical significant difference was found between baseline and week 12 after initial treatment (P = 0.65, 0.31, 0.12, respectively). No obvious progress of the fibrosis was detected in most of the PDT treated eyes. Eleven cases of adverse events (AE) occurred in our trial and the incidence was 34.4%. Among the 11 patients with reported adverse event, 7 (21.9%) had mild adverse event; 3 (9.4%) had moderate adverse events; 1 (3.1%) had a serious adverse event. During the study period, no abnormal changes were found in most of the laboratory tests including serum and urine biochemistry, hematology and Electrocardiogram.
Conclusions: The results of this trial showed positive efficacy of PDT with verteporfin in the treatment of predominantly subfoveal CNV secondary to AMD by reducing the risk of vision loss. The incidence of serious adverse events was only 3.1%. It is highly safe to use PDT with verteporfin in Chinese AMD patients with subfoveal predominant classical CNV.