Systemic Bevacizumab (Avastin®) Therapy for Exudative Neovascular Age-Related Macular Degeneration (BEAT-AMD-Study) - BEAT-AMD-Study
- Conditions
- 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.
- Registration Number
- EUCTR2005-001722-92-AT
- Lead Sponsor
- The Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 30
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
Patients who had arterial thromboembolic diseases
Patients with: Cancer, proteinuria, renal impairment, hepatic dysfunction, vision threatening ophthalmic diseases other than AMD
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the effect of systemic bevacizumab therapy in patients with<br>fibrovascular pigment epithelium detachment (PED), involving the geometric<br>center of the foveal avascular zone, in comparison to placebo treatment with<br>natrium chloride 0,9%.<br>;Secondary Objective: ;Primary end point(s): Duration of the study is 24 weeks for every patient.
- Secondary Outcome Measures
Name Time Method