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The purpose of the study is to compare the effect of intravitreal injections of ranibizumab and aflibercept on systemic VEGF protein levels in DME patients in a detailed time course.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Monthly intravitreal injections of 0.5 mg ranibizumab |
|
| Group 2 | Experimental | Three monthly intravitreal injections of 2 mg aflibercept followed by three monthly intravitreal injections of 0.5 mg ranibizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab | Drug | 0.5 mg intravitreal injections |
|
| Measure | Description | Time Frame |
|---|---|---|
| Systemic VEGF-A protein levels | Systemic VEGF-A protein levels following monthly intravitreal injections of 0.5 mg ranibizumab versus 2 mg aflibercept (Area under the curve) | From baseline to study week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Systemic VEGF-A protein levels | Systemic VEGF-A protein levels in patients switching from monthly 2 mg aflibercept injections to monthly 0.5 mg ranibizumab compared to patients treated with 0.5 mg ranibizumab from baseline | From study week 12 to 24 |
| Systemic VEGF-A levels |
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Inclusion Criteria:
Exclusion Criteria:
For either eye:
For study eye:
For fellow eye
- Retinal or choroidal neovascularization or macula edema of any cause
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceutical | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Chemnitz | 09113 | Germany |
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| Aflibercept | Drug | 2 mg intravitreal injections |
|
|
Adjustment of systemic VEGF-A levels of patients switching from aflibercept to ranibizumab to levels comparable to baseline or to levels comparable as in patients treated from baseline with ranibizumab |
| From study week 12 to 24 |
| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| C533178 | aflibercept |
| 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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