SnET2 PHOTODYNAMIC THERAPY FOR EXUDATIVE AGE–RELATED MACULAR DEGENERATION: LESION RESPONSE IN TWO PARALLEL PHASE III TRIALS

Abstract

Abstract: : Purpose: To present lesion response efficacy data observed over a 2–year study period from two Phase III randomized trials evaluating SnET2–PDT in the treatment of subfoveal CNV secondary to AMD. Methods: Two parallel phase III trials evaluated a total of 920 patients. SnET2 doses of 0.50 mg/kg (N=372), 0.75 mg/kg (N=365) or placebo (N=183) were administered to patients with re–treatment possible every 13 weeks. Inclusion criteria were total lesion size equal to or less than 3000 microns in greatest diameter, visual acuity of 15 or more ETDRS letters, and all lesion subtypes. The lesions were evaluated by fundus photography and fluorescein angiography at 3 month intervals for 2 years and analyzed. Results: The pooled SnET2 0.50 mg/kg groups showed a reduction in lesion growth relative to placebo that was statistically significant at time points up to year 1 (p=0.01 at week 52, ANOVA), but not thereafter (p=0.07 at week 103). The area of subretinal fluid was consistently less than placebo at all time periods in the 0.50 mg/kg group and was significant at all but the week 77 and 103 visits. The area of fluorescein leakage was also less in the SnET2 group (figure). No statistically significant treatment group differences were found between the placebo and SnET2 0.75 mg/kg groups. Conclusion: SnET2 0.50 mg/kg lessened neovascular growth, fluorescein leakage, and subretinal fluid over 2 years.  

Keywords: age–related macular degeneration • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials