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| Name | Class |
|---|---|
| Novartis Pharmaceuticals | INDUSTRY |
| University Medical Center Goettingen | OTHER |
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This clinical trial investigates the impact of intravitreal injection of Ranibizumab antibody on the acuteness of vision. Patients included are suffering from choroidal neo-vascularization (CNV) as a consequence of age-related macular degeneration (AMD).
Initially, all patients get injections of 0.5 mg Ranibizumab in monthly intervals for 3 months. Subsequently, one group gets Ranibizumab in intervals of 2 months, whereas a second group is treated on demand.
The primary end point of the study is the change of best-corrected visual acuity after 12 month.
Secondary end points include the impact of Ranibizumab on morphological changes of the retina, the number of patients with gain or loss of 15 or more letters visual acuity after 12 months, changes in quality of life and the number of injections required during the first 12 months of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranibizumab fixed dose | Experimental | Injection of 0.5 mg Ranibizumab every 2 months for one year, following a monthly injection during the first 3 months. |
|
| Ranibizumab on demand | Experimental | Injection of 0.5 mg Ranibizumab on demand for one year, following a monthly injection during the first 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab | Biological |
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| Measure | Description | Time Frame |
|---|---|---|
| best-corrected visual acuity | Change of best-corrected visual acuity before and 12 months after start of treatment with respect to number of letters read on ETDRS-sheets (Early Treatment Diabetes Retinopathy Study Sheets). | 12 months after start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Fluoresceinangiography | To study morphological and anatomical changes of the retina. Affected area is determined in mm² | 12 months after start of treatment |
| Photography | To study morphological and anatomical changes of the retina. Affected area is assessed by computer-assisted measurement in mm². |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Ophthalmology, University Medical Center Goettingen | Göttingen | 37075 | Germany |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| 12 months after treatment start |
| optical coherence tomography (OCT) | To study morphological and anatomical changes of the retina. Thickness of the retina is determined in µm². | 12 months after treatment start |
| number of injections | 12 months after treatment start |
| quality of life | change in quality of life | 12 months after treatment start |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |