Efficacy and Safety of Ranibizumab in Japanese Patients With Retinal Vein Occlusion

Study Overview
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Brief Summary
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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.

Official Title
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A 3-month, Phase III, Open-label, Single Arm, Multicenter Study Assessing the Efficacy and Safety of 0.5 mg Ranibizumab Monthly Intravitreal Injections as Monotherapy in Patients With Visual Impairment Due to Macular Edema Secondary to Branch or Central Retinal Vein Occlusion (RVO)

Conditions
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Retinal Vein Occlusion

Intervention / Treatment
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* Drug: ranibizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Japanese patients diagnosed with visual impairment exclusively due to macular edema secondary to either branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) Diagnosis within 12 months prior to Visit 1 Best-corrected visual acuity (BCVA): CRVO: BCVA score ≥24 and ≤73 letters ETDRS (approx. Snellen equivalent of 20/320 and 20/40) at Visit 1 and 2 BRVO: BCVA score ≥19 and ≤73 letters ETDRS (approx. Snellen equivalent of 20/400 and 20/40) at Visit 1 and 2 Exclusion Criteria: Pregnant or nursing women History of stroke Uncontrolled blood pressure Active ocular infection or intraocular inflammation in either eye Uncontrolled glaucoma in either eye Neovascularization of the iris or neovascular glaucoma in either eye Prior episode of RVO more than 12 months prior to Visit 1 in the study eye Use of any systemic anti-VEGF drugs within 6 months prior to Visit 2 Prior treatment with any anti-angiogenic drugs within 3 months prior to Visit 2 in either eye Prior panretinal laser photocoagulation within 3 months prior to Visit 2 in the study eye Prior focal/grid laser photocoagulation within 4 months prior to Visit 2 in the study eye Use of intra-/peri-ocular corticosteroids within 3 months prior to Visit 1 in the study eye Use of any intra-ocular corticosteroid implants in the study eye Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ranibizumab intravitreal injection<br> | Drug: ranibizumab<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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retinal vein occlusion, branch retinal vein occlusion, central retinal vein occlusion, visual impairment, macular edema, ranibizumab