Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery Krankenanstalt Rudolfstiftung Medizinische Universität Wien Medical University of Graz Medical University Innsbruck Krankenhaus der Barmherzigen Brüder Linz Universitätsaugenklinik Salzburg Hospital Hietzing Hanuschkrankenhaus |
---|---|
Information provided by: | The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery |
ClinicalTrials.gov Identifier: | NCT00710229 |
Angiogenesis plays a key role in the development of choroidal neovascularizations (CNV) in age-related macular degeneration. Vascular endothelial growth factor (VEGF) is the most important factor involved in this angiogenetic processes in the eye. This forms the basis for new therapeutic interventions in exudative AMD. Currently two drugs have been approved by the FDA and one drug is used off-label. All these drugs are administered intravitreally. The present study aims to directly compare the effects ranibizumab and bevacizumab in a randomized controlled study in patients with neovascular AMD.
Condition | Intervention | Phase |
---|---|---|
Age Related Macular Degeneration |
Drug: Ranibizumab Drug: Bevacizumab |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | A Randomized Observer and Subject Masked Trial Comparing the Visual Outcome After Treatment With Ranibizumab or Bevacizumab in Patients With Neovascular Age-Related Macular Degeneration Multicenter Anti VEGF Trial in Austria (MANTA) |
Estimated Enrollment: | 320 |
Study Start Date: | July 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Active Comparator
Intravitreal injectin of Ranibizumab (3 monthly injection followed by monthly injectins as long as required
|
Drug: Ranibizumab
intravitreal injection
|
B: Active Comparator
Intravitreal injectin of Bevacizumab (3 monthly injection followed by monthly injectins as long as required
|
Drug: Bevacizumab
intravitreal injection
|
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Prior treatment with any intravitreal drug in the study eye
Contact: Ilse Krebs, MD | 43-17-1165 ext 94682 | Ilse.Krebs@wienkav.at |
Austria | |
Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery | |
Vienna, Austria, 1030 |
Responsible Party: | The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery ( Susanne Binder Prof ) |
Study ID Numbers: | EK 07-192-1007 |
Study First Received: | July 1, 2008 |
Last Updated: | July 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00710229 History of Changes |
Health Authority: | Austria: Ethikkommission |
age related macular degeneration Ranibizumab-Lucentis Bevacizumab-Avastin |
Eye Diseases Retinal Degeneration Macular Degeneration |
Bevacizumab Angiogenesis Inhibitors Retinal Diseases |
Antineoplastic Agents Eye Diseases Growth Substances Physiological Effects of Drugs Macular Degeneration Retinal Degeneration Bevacizumab |
Angiogenesis Inhibitors Pharmacologic Actions Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors Retinal Diseases |