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Sponsors and Collaborators: |
Klinikum Bremen-Mitte, gGmbH Kompetenzzentrum für Klinische Studien, Bremen |
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Information provided by: | Klinikum Bremen-Mitte, gGmbH |
ClinicalTrials.gov Identifier: | NCT00559715 |
The study is designed to demonstrate the therapeutic non-inferiority of the recombinant humanized monoclonal VEGF antibody bevacizumab administered by intravitreal injection in the treatment of AMD in comparison to the related fragment ranibizumab.
Condition | Intervention | Phase |
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Age-Related Neovascular Macular Degeneration |
Drug: bevacizumab Drug: ranibizumab |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Prevention of Vision Loss in Patients With Age-Related Neovascular Macular Degeneration by Intravitreal Injection of Bevacizumab and Ranibizumab in a Typical Outpatient Setting |
Estimated Enrollment: | 366 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental |
Drug: bevacizumab
1.25 mg intravitreally monthly/on demand
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B: Active Comparator |
Drug: ranibizumab
0.5 mg intravitreally monthly/on demand
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Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with visual impairment (best corrected visual acuity of 20/40 to 20/320 (Snellen equivalent, ETDRS chart)) due to an active primary or recurrent CNV associated with age-related macular degeneration involving the foveal center, presenting with either:
Exclusion Criteria:
Contact: Bernd Muehlbauer, Professor MD | +49 (0) 421 497 5352 | b.muehlbauer@pharmakologie-bremen.de |
Germany | |
Department of Pharmacology at Klinikum Bremen Mitte | Recruiting |
Bremen, Germany, 28177 | |
Contact: Bernd Muehlbauer, Professor MD +49 (0) 421 497 5352 b.muehlbauer@pharmakologie-bremen.de |
Principal Investigator: | Bernd Muehlbauer, Professor MD | Department of Pharmacology, Klinikum Bremen Mitte, Bremen, Germany |
Responsible Party: | Klinikum Bremen Mitte gGmbH ( Bernd Muehlbauer, Professor MD ) |
Study ID Numbers: | VIBERA_2007-004721-23 |
Study First Received: | November 15, 2007 |
Last Updated: | March 25, 2009 |
ClinicalTrials.gov Identifier: | NCT00559715 History of Changes |
Health Authority: | Germany: Ethics Commission |
bevacizumab ranibizumab macular degeneration age-related |
neovascular intravitreal injection vision loss outpatient setting |
Signs and Symptoms Sensation Disorders Vision Disorders Eye Diseases Neurologic Manifestations Retinal Degeneration |
Macular Degeneration Bevacizumab Blindness Angiogenesis Inhibitors Retinal Diseases |
Sensation Disorders Vision Disorders Antineoplastic Agents Growth Substances Eye Diseases Physiological Effects of Drugs Nervous System Diseases Macular Degeneration Retinal Degeneration Blindness |
Bevacizumab Angiogenesis Inhibitors Pharmacologic Actions Signs and Symptoms Therapeutic Uses Neurologic Manifestations Growth Inhibitors Angiogenesis Modulating Agents Retinal Diseases |