Abstract
Purpose: :
To compare the functional, morphological and angiographical effects of the combination therapy of reduced fluence PDT (rPDT; 300 mW/cm2) and IVTA with standard fluence PDT (sPDT; 600 mW/cm2) and IVTA in patients with choroidal neovascularisation (CNV) secondary to age-related macular degeneration.
Methods: :
Fourty patients were included in this prospective, comparative clinical trial and were randomized equally to one of the two groups. Visual acuity (VA) was measured using ETDRS charts at 2 meters. Central retinal thickness (CRT) was assessed using Stratus OCT (Zeiss), leakage activity of the CNV was evaluated using fluorescein angiography (FA). Macular sensitivity (MS) was measured using the MP-1 microperimeter (Nidek). Examinations were done at baseline, 3, 6, 9 and 12 months after initial treatment.
Results: :
VA improved from 37.5±2.3 to 38.6±4.2 letters in the rPDT group (p=0.8), and decreased from 38.1±4.3 to 31.6±4.5 letters (p=0.21) in the sPDT group. The difference in visual acuity was not statistically significant. CRT decreased from 319.6±31.6 to 210.3±17.1µm (p=0.01) in the rPDT and from 315.4±23.1 to 267.6±25.2µm (p=0.20) in the sPDT group. The difference was not statistically significant. In FA, early phase leakage area increased from 3.7±0.3 to 4.0±0.3mm2 and from 2.8±0.3 to 3.7±0.3mm2, late phase leakage area increased from 4.1±0.3 to 4.3±0.2mm2 and from 3.5±0.3 to 4.1±0.3mm2 in the rPDT and sPDT group, respectively, without statistical significance between the two groups (p>0.05). Macular sensitivity decreased from 5.4±0.8 to 4.9±0.8dB (p=0.49) in the rPDT group and from 4.71±0.7 to 3.5±0.9dB (p=0.16) in the sPDT group, again without statistically significant differences between both groups (p>0.05). On average, patients in the rPDT received 1.68, patients in the sPDT group 1.71 treatments (p=0.94).
Conclusions: :
Although there were no significant differences between the two groups, overall results showed a trend that PDT with reduced fluence is superior to PDT with standard fluence when combined with IVTA.
Clinical Trial: :
www.clinicaltrials.gov NCT00523406
Keywords: choroid • age-related macular degeneration • photodynamic therapy