Abstract
Purpose::
To compare functional and anatomic effects of reduced fluence (RF) and standard fluence (SF) verteporfin therapy (PDT) combined with intravitreal triamcinolone acetate (IVTA) in patients with neovascular age-related macular degeneration (AMD).
Methods::
Forty eyes of 40 patients with neovascular AMD were enrolled in a prospective, randomized, double blinded trial. The study was approved by the ethics committee at the Medical University Vienna and registered at the European Clinical Trial Database. Patients either received RF PDT (n=20) or SF PDT (n=20) each followed by same day 4mg IVTA. Follow-up examinations were at 1 day, 1 week, 1 and 3 months. Best corrected visual acuity (BCVA) using ETDRS charts, fluorescein angiography (FA), and indocyanin green angiography (ICGA) were performed at each of follow-up visit. Macular sensitivity (MS) was evaluated using Microperimetry 1 (MP1, Nidek). BCVA, MS and central retinal thickness (CRT) were defined as primary outcomes, chorioretinal perfusion, perfusion of the neovascular net and the retreatment rate as secondary outcomes.
Results::
Baseline characteristics were well balanced in both groups. Both treatment groups showed a similar course regarding BCVA and CRT (p>0.05). At month 3 patients showed stabilisation in mean BCVA of -3 letters in the RF PDT-IVTA group versus -4 letters in SF PDT-IVTA (p>0.05). Compared to baseline both treatment groups showed a considerable increase in mean CRT at day 1 and a significant reduction of CRT at months 1 and 3. There was a trend for better MP1 outcomes in the RF PDT-IVTA group with regard to mean MS. Mean change in MS at month 3 was +1.3db in the RF PDT-IVTA group versus -0.3db in the SF PDT-IVTA group. In 53% of RF PDT-IVTA patients a recurrent CNV was observed, whereas in SF PDT-IVTA group a recurrent rate of 78% was documented. Evaluation of early FA and ICGA demonstrated less effect on the choroid in the RF PDT-IVTA group.
Conclusions::
At month 3, RF PDT-IVTA group showed a trend of a better macular sensitivity, less effect on the choroid and a significantly lower recurrent rate than SF PDT-IVTA group. Further follow-up of this study will provide information on long-term functional results and treatment durability.
Clinical Trial::
EUDRACT
Keywords: choroid: neovascularization • photodynamic therapy • age-related macular degeneration