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| ID | Type | Description | Link |
|---|---|---|---|
| CRFB002DHU06T |
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| Name | Class |
|---|---|
| Semmelweis University | OTHER |
| Csolnoky Ferenc County Hospital | UNKNOWN |
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This study investigates the hypothesis that ranibizumab injection given into the eye is an efficacious and safe treatment option applied for swelling of the macula (site of sharp vision) in diabetes.
This is a randomized, controlled, three-center trial to assess the efficacy and safety of intravitreal ranibizumab injections in diabetic macular edema. Comparator arm consists of patients receiving macular grid-pattern laser therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ranibizumab group | patients receiving intravitreal ranibizumab for diabetic macular edema |
| |
| laser | patients receiving macular grid-pattern laser therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ranibizumab | Drug | 10mg/ml intravitreal injection |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Mean change in best corrected visual acuity | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in retinal thickness as assessed with OCT | 12 months | |
| Change in the extension of foveal avascular zone, foveal thickness and macular volume by FA and OCT, respectively. | 12 months | |
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Inclusion Criteria:
Exclusion Criteria:
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Diabetes patients having clinically significant macular edema due to diabetic retinopathy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rozsa Degi, assoc prof | Contact | +36 30 279 4330 | drdegirozsa@freemail.hu | |
| Barbara B Toth, assistlect | Contact | +36 30 239 3020 | btothbarbara@freemail.hu |
| Name | Affiliation | Role |
|---|---|---|
| Lajos Kolozsvari, prof | Szeged University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Semmelweis University Department of Ophthalmology | Recruiting | Budapest | H-1085 | Hungary |
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| ID | Term |
|---|---|
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| 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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| macular grid-pattern laser | Radiation | macular grid-pattern laser therapy |
|
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| Change in retinal function (color vision,contrast sensitivity, multifocal ERG) |
| 12 months |
| Rate of adverse events | 12 months |
| University of Szeged, Medical and Pharmaceutical Center, Department of Ophthalmology | Recruiting | Szeged | H-6721 | Hungary |
|
| Csolnoky Ferenc County Hospital Dept of Ophthalmolgy | Recruiting | Veszprém | H-8200 | Hungary |
|
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |