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.
Conditions
Interventions
Trade Name: Avastin
Product Name: Avastin
Pharmaceutical Form: Intravenous infusion
Trade Name: Visudyne /verteporfin
Product Name: Visudyne
Pharmaceutical Form: Intravenous infusion
Pharmaceutical f
Sponsors
St. Eriks Eye Hospital
St. Eriks Eye Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: Patients 4 disc areas - Subretinal hemorrhage involving macular area and which is >= 1 disc area or >=50% of the total lesion - Subretinal fibrosis in the fovea - Previous treatment using vitreoretinal surgery, PDT, transpupillary thermotherapy (TTT), argon or krypton laser, anecortave acetate or anti-VEGF agents for ocular use. - Retinal vascular disease of any origin, leading to neovascularization - Diabetic retinopathy - Uncontrolled arterial hypertension - Coronary infarction within the last 12 months - Stroke within the last 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;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;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 | — |
Countries
Sweden
Outcome results
None listed