A prospective, randomized, masked and controlled trial of intravitreal bevacizumab (Avastin) versus verteporfin photodynamic therapy (PDT) in patients with neovascular age-related macular degeneration.

INTERVENTION: Trade Name: Avastin Product Name: Avastin Pharmaceutical Form: Intravenous infusion Trade Name: Visudyne /verteporfin Product Name: Visudyne Pharmaceutical Form: Intravenous infusion Pharmaceutical form of the placebo: Intravenous infusion Route of administration of the placebo: Intravenous bolus use (Noncurrent) CONDITION: Age‐related macular degeneration (AMD) is the leading cause of visual impairment and social blindness in people 60 years or older. Approximately 75% of patients with severe visual loss exhibit neovascular AMD with choroidal neovascularization (CNV). Newly formed vessels invade the retinal pigment epithelium (RPE) and neural retina, causing edema and hemorrhage, ultimately inducing damage or apoptotic cell death of photoreceptors. PRIMARY OUTCOME: Main Objective: To compare the safety and efficacy of intravitreal bevacizumab (Avastin) with verteporfin photodynamic therapy (PDT) in patients with neovascular AMD. ; ; This Avastin vs. PDT for neovascular AMD Study will evaluate whether treatment with intravitreal bevacizumab yields better visual and clinical results than conventional verteporfin PDT. Primary end point(s): ‐ Fraction (number) of patients who lose < 15 ETDRS letters from baseline; ‐ Fraction (number) of patients who gain at least 15 ETDRS letter from baseline Secondary Objective: Fraction (per centage) of patients who maintain visual acuity (losing < 15 ETDRS letters) from baseline; Fraction (per centage) of patients who gain at least 15 ETDRS letters from baseline INCLUSION CRITERIA: Patients with neovascular AMD aged 50 years or more who have a visual acuity 0,1 (20/200) or better ‐ Classic or predominantly classic choroidal neovascularization (CNV) ‐ Occult CNV with extension 4 disc areas or less Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range