Abstract
Purpose: :
to assess functional and structural retinal changes in patients with neovascular age-related macular degeneration (nAMD) treated with intravitreal ranibizumab 0.5 mg combined with a single session photodynamic therapy (PDT) 3 days after the first injection.
Methods: :
patients with nAMD have been evaluated in this prospective interventional open label 12 months follow-up study. All patients have been treated with 3 injections of ranibizumab 0.5 mg 1 month apart and retreated according to predefined criteria. At baseline all patients received a single session of PDT 3 days after the first injection. All patients at baseline were subjected to visual acuity (VA), fluorescein angiography, MP1 microperimetry and OCT. While VA and OCT were repeated 28±2 days after each injection, FA and MP1 were repeated at 6 and 12 months.
Results: :
12/15 nAMD patients completed 12 months follow up. Mean VA improved from 54.67±15.72 to 59.0±24.77 at 12 months with a mean change of 4.33 letters (95%CI -5.90/14.56; p=0.371). VA improved ≥ 15 letters in 25% (3/12) of patients. Mean retinal sensitivity showed a not statistically significant improvement from baseline ranging from 5.5±4.8 dB to 6.6±6.0 with a mean change of 1.1 dB (95%CI -0.8/3.0; p=0.216) at 12 months. At baseline 66.6% of patients presented an instable or relatively instable fixation (8/12) while at 12 months the percentage decreased to 50% (6/12). Mean central retinal thickness significantly decreased from 356±143 to 219±65 with a mean change of -136 µm (95%CI -197/-76; p=<.001) at 12 months.
Conclusions: :
intravitreal injections of ranibizumab 0.5 mg combined with one single session of PDT 3 days after the first injection seem to determine a stabilization of functional retinal parameters.
Clinical Trial: :
http://www.clinicaltrials.gov NCT00574093
Keywords: choroid: neovascularization • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • vascular endothelial growth factor