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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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A prospective multicenter study comparing patients with CRVO amd secondary macular edema treated with ranibizumab versus sham. Safety and efficacy will be evaluated. Patients will be randomized in a 1:1 ratio to one of the two arms. 32 patients, 6 months follow up. There will be monthly visits with injection the first three months and subsequently new injection if present edema.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | 0.5 ml 10mg/ml (0.5 mg) ranibizumab for intravitreal injection |
|
| B | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ranibizumab | Drug | 0.5 ml 10mg/ml (0.5 mg) ranibizumab for intravitreal injection. Monthly injection for 3 months, followed by reinjection if edema for a total of 6 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy outcome measure is the mean change from baseline in BCVA score | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in BCVA score, central foveal thickness and in the NEI VFQ-25 near activities subscale. | 6 months |
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Inclusion Criteria:
Male and female ≥ 50 years
Patients who have findings consistent with CRVO
Patients who have a history of decreased visual acuity ≤ 6 months
Patients who have a best corrected visual acuity (BCVA) letter score in the study eye of ≤ 73 (4 m distance) or ≥ 6 (1 m distance) using an ETDRS chart
Patients who have a macular edema verified by OCT
Patients who have macular edema in the study eye with the following characteristics as determined by fluorescein angiography:
Willing and able to give written informed consent and who are willing and able to comply with study procedures
Ability to cooperate with photo and OCT examinations
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bettina Kinge, MD DMSc | Aleris Helse, Oslo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bettina Kinge, Retinaklinikken Aleris | Oslo | 0264 | Norway | |||
| Ingar Stene Johansen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20591399 | Derived | Kinge B, Stordahl PB, Forsaa V, Fossen K, Haugstad M, Helgesen OH, Seland J, Stene-Johansen I. Efficacy of ranibizumab in patients with macular edema secondary to central retinal vein occlusion: results from the sham-controlled ROCC study. Am J Ophthalmol. 2010 Sep;150(3):310-4. doi: 10.1016/j.ajo.2010.03.028. Epub 2010 Jun 29. |
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| ID | Term |
|---|---|
| D012170 | Retinal Vein Occlusion |
| 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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| ranibizumab | Drug | Sham injection with an empty, sterile 3-ml stopped glass vial. # monthly sham-injections, followed by reinjection for 3 months if present edema. |
|
| Oslo |
| Norway |
| Vegard Forsaa | Stavanger | Norway |
| Kristian Fossen | Tromsø | Norway |
| D016769 |
| Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |