This study is an evaluation of the short term effects on CNV perfusion of a same-day administration of photodynamic therapy (PDT) with Visudyne® and an intravitreal injection of Lucentis® (ranibizumab, 0.3 mg). An evaluation of the short term effects on CNV perfusion of this combined treatment is needed for better understanding of treatment effects.
The primary objective is to quantify the short term effects on CNV perfusion of the same-day administration of photodynamic therapy with Visudyne® and an intravitreal injection of ranibizumab. These short term effects will be assessed with visual acuity measurements and ophthalmic examinations including indocyanine green (ICG) and fluorescein angiography (FA) as well as Optical Coherence Tomography (OCT) measurements. The primary variable for this assessment is the incidence of CNV closure one week after combined therapy as assessed with high speed ICG angiography. Fluorescein and ICG angiography will be performed using a scanning laser ophthalmoscope (HRA). All angiographic studies and OCT examinations will be evaluated by the Bern Photographic Reading Center in a masked fashion. Visual acuity assessments will be performed with Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. A secondary objective is to explore the effect of the same-day administration of photodynamic therapy with Visudyne® and an intravitreal injection of ranibizumab: * on retinal thickness as measured by OCT over time * in change of total lesion area, area of CNV assessed by FA * in mean change of VA from baseline over time
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Intravitreal injection, photodynamic therapy
Klinik und Poliklinik fuer Augenheilkunde, Inselspital
Bern, Switzerland
incidence of CNV closure one week after combined therapy as assessed with high speed ICG angiography
Time frame: 24 months
retinal thickness as measured by OCT over time
Time frame: 24 months
change of total lesion area, area of CNV and area of leakage over time as assessed by FA
Time frame: 24 months
mean change of VA from baseline over time
Time frame: 24 months
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