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| Name | Class |
|---|---|
| Norvartis Pharma, Nuremberg, Germany | UNKNOWN |
| Coordination center for clinical studies, Mainz, Germany | UNKNOWN |
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The primary objective of this pilot study is to compare the functional and anatomic outcomes of chronic macular edema secondary to branch retinal vein occlusion (BRVO) treated with argon laser photocoagulation versus intravitreal ranibizumab (Lucentis®) injection versus a combination of both.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | laser photocoagulation to the retina at the area of edema |
|
| 2 | Experimental | intravitreal injection of ranibizumab |
|
| 3 | Experimental | laser photocoagulation to the retina at the area of edema and intravitreal injection of ranibizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab | Drug | intravitreal injection of 0.5 mg ranibizumab after randomisation, at week 4 and 8 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in best spectacle-corrected visual acuity (BSCVA) | from baseline to month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in BSCVA | from baseline to month 3 | |
| Proportion of patients who gain ≥ 5, 10, 15 letters of BSCVA | from baseline to month 3 and 6 | |
| Proportion of patients who lose less than 15 letters of BCVA |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars-Olof Hattenbach, MD, Privatdozent | Dept. of Ophthalmology, Ludwigshafen hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RABAMES investigational trial site | Freiburg im Breisgau | Germany | ||||
| RABAMES investigational trial site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25042729 | Derived | Pielen A, Mirshahi A, Feltgen N, Lorenz K, Korb C, Junker B, Schaefer C, Zwiener I, Hattenbach LO; RABAMES Study Group. Ranibizumab for Branch Retinal Vein Occlusion Associated Macular Edema Study (RABAMES): six-month results of a prospective randomized clinical trial. Acta Ophthalmol. 2015 Feb;93(1):e29-37. doi: 10.1111/aos.12488. Epub 2014 Jul 8. |
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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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| Laser photocoagulation | Procedure | laser photocoagulation to the retina at the area of edema |
|
| from baseline to month 3 and 6 |
| Change in area and intensity of leakage | from baseline to month 1, 3 and 6 |
| Mean change in central macular thickness (by OCT) | from baseline to month 1, 3 and 6 |
| Mean change in central macular thickness (by OCT) | from month 3 to 6 |
| Göttingen |
| Germany |
| RABAMES investigational trial site | Ludwigshafen | 67063 | Germany |
| RABAMES investigational trial site | Mainz | Germany |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |