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The purpose of this study is to provide efficacy and safety data of 3 consecutive monthly intravitreal injections with 0.5 mg ranibizumab in Japanese patients with visual impairment due to macular edema secondary to retinal vein occlusion (BRVO or CRVO) to support the applicability of the phase III study results of BRAVO and CRUISE in this indication, in the Japanese ethnic patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ranibizumab intravitreal injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ranibizumab | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measure: Efficacy of 3 consecutive monthly intravitreal injections with 0.5 mg ranibizumab as assessed by the mean average change in best-corrected visual acuity (BCVA) from Month 1 through Month 3 compared to baseline | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Measure: Efficacy of monthly ranibizumab injections as assessed by the mean BCVA change from baseline over time to Month 3, by visit | 3 months | |
| Measure: Efficacy of monthly ranibizumab injections as assessed by the mean change in central subfield thickness (CSFT) of the retina from baseline over time to Month 3 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Novartis Pharma AG | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Nagoya | Aichi-ken | 466-8560 | Japan | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27654837 | Result | Kamei M, Terasaki H, Yoshimura N, Shiraga F, Ogura Y, Grotzfeld AS, Pilz S, Ishibashi T. Short-term efficacy and safety of ranibizumab for macular oedema secondary to retinal vein occlusion in Japanese patients. Acta Ophthalmol. 2017 Feb;95(1):e29-e35. doi: 10.1111/aos.13196. Epub 2016 Sep 22. |
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| ID | Term |
|---|---|
| D012170 | Retinal Vein Occlusion |
| D014786 | Vision Disorders |
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
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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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| 3 months |
| Measure: Efficacy of monthly ranibizumab injections as assessed by the proportion of patients achieving BCVA improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 letters from baseline to Month 3 | 3 months |
| Measure: Efficacy of monthly ranibizumab injections as assessed by the proportion of patients with a BCVA loss of <15 letters from baseline to Month 3 | 3 months |
| Measure: Safety of monthly ranibizumab injections as assessed by the type, frequency and severity of adverse events | 3 months |
| Nagoya |
| Aichi-ken |
| 467-8602 |
| Japan |
| Novartis Investigative Site | Fukuoka | Fukuoka | 812-8582 | Japan |
| Novartis Investigative Site | Kita-gun | Kagawa-ken | 761-0793 | Japan |
| Novartis Investigative Site | Kyoto | Kyoto | 606-8507 | Japan |
| Novartis Investigative Site | Osaka | Osaka | 545-8586 | Japan |
| Novartis Investigative Site | Suita | Osaka | 565-0871 | Japan |
| Novartis Investigative Site | Ohtsu | Shiga | 520-2192 | Japan |
| D016769 |
| Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |