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| Name | Class |
|---|---|
| Kompetenzzentrum für Klinische Studien, Bremen | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab | Drug | 1.25 mg intravitreally monthly/on demand |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with a loss of fewer than 15 letters at month 12 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with a loss of fewer than 15 letters at month 24 | 2 years | |
| Mean change from baseline in BCVA at month 12 (IA) and month 24 | 2 years | |
| Proportion of patients with a treatment-free interval of at least 3 months' duration at any time point following month 2 |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bernd Muehlbauer, Professor MD | Contact | +49 (0) 421 497 5352 | b.muehlbauer@pharmakologie-bremen.de |
| Name | Affiliation | Role |
|---|---|---|
| Bernd Muehlbauer, Professor MD | Department of Pharmacology, Klinikum Bremen Mitte, Bremen, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pharmacology at Klinikum Bremen Mitte | Recruiting | Bremen | 28177 | Germany |
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| ranibizumab | Drug | 0.5 mg intravitreally monthly/on demand |
|
|
| 2 years |
| Number of doses of the study drugs | 2 years |
| Drop out rates | 2 years |
| Rate of non-responders | 2 years |
| Retinal lesions | 2 years |
| Adverse Events | 2 years |
| Quality of Life | 2 years |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D014786 | Vision Disorders |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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