Age related macular degeneration (AMD) patients with fibrovascular pigment epithelium detachment (PED), subfoveal choroidal neovascularisations (CNV) extending under the geometric center of the foveal avascular zone, and a central retinal thickness of at least 300 microns.
Conditions
Interventions
Product Name: Avastin (Bevacizumab)
Pharmaceutical Form: Solution for infusion
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Sponsors
The Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: AMD patients with fibrovascular pigment epithelium detachment (PED), subfoveal choroidal neovascularisations (CNV) extending under the geometric center of the foveal avascular zone, and a central retinal thickness of at least 300 microns. 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 who had arterial thromboembolic diseases Patients with: Cancer, proteinuria, renal impairment, hepatic dysfunction, vision threatening ophthalmic diseases other than AMD
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effect of systemic bevacizumab therapy in patients with fibrovascular pigment epithelium detachment (PED), involving the geometric center of the foveal avascular zone, in comparison to placebo treatment with natrium chloride 0,9%. ;Secondary Objective: ;Primary end point(s): Duration of the study is 24 weeks for every patient. | — |
Countries
Austria
Outcome results
None listed