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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002202-70 | EudraCT Number |
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In this prospective, open-label clinical study is to investigate the behavior of the retinal functions during development of diabetic macular disease (DME) under the influence of Lucentis. Measurements with the multifocal electroretinogram (ERG) and microperimetry is used here as an objective criteria to information about the retinal function obtain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lucentis (Ranibizumab) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lucentis (Ranibizumab) | Drug | Ranibizumab Short- and Log-term Effects on Retinal Function measured by Multifocal-ERG and Microperimetry |
|
| Measure | Description | Time Frame |
|---|---|---|
| Main outcome measures are the changes of retinal function of the macula monitored by multifocal-ERG as measured 12 months | Main outcome measures are the changes of retinal function of the macula monitored by multifocal-ERG as measured 12 months | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| to document changes in best corrected visual acuity measured on 4 meters | to document changes in best corrected visual acuity measured on 4 meters | 12 months |
| to document changes in microperimetry |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Salvatore Grisanti, M.D. Prof. | University of Luebeck - Department of Ophthalmology: Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Luebeck - Department of Ophthalmology | Lübeck | Germany |
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| Label | URL |
|---|---|
| Link Text: University of Lübeck - Department of Ophthalmology - Germany | View source |
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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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to document changes in microperimetry
| 12 months |
| to document changes in optical coherence tomography (OCT) | to document changes in optical coherence tomography (OCT) | 12 months |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |