Effect of Ozurdex® 0.7 mg on Improvement of Efficacy of Bevacizumab for Central Retinal Vein Occlusion

Study Overview
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Brief Summary
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This is a study designed to determine if the addition of Ozurdex® to bevacizumab (Avastin®) eye injections reduces the need for repeat bevacizumab eye injections in patients with nonischemic central retina vein occlusion.

Detailed Description
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This is a multicenter clinical study designed to determine if the addition of Ozurdex® injection to bevacizumab (Avastin®) eye injections reduces the need for repeat bevacizumab eye injections in patients with nonischemic central retina vein occlusion.

Official Title
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Effect of Ozurdex® 0.7 mg on Improvement of Efficacy of Bevacizumab Therapy for Non-Ischemic Central Retinal Vein Occlusion

Conditions
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Non-Ischemic Central Retinal Vein Occlusion

Intervention / Treatment
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* Drug: Active bevacizumab and Sham dexamethasone
* Drug: Active bevacizumab and Active dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male or female subjects (aged 18 or older); provide written informed consent and sign/date a health information release; women of childbearing potential must be willing to practice effective contraception for the duration of the study. Exclusion Criteria: any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results; use of systemic steroids within 1 month prior to Baseline Visit (Visit 1) or anticipated use at any time during the study (inhaled and intranasal steroids are allowed); sitting systolic blood pressure equal to or greater than 160 mmHg or diastolic blood pressure equal to or greater than 100 mmHg at the Baseline Visit (Visit 1); use of warfarin, heparin, enoxaparin or similar anticoagulants within 2 weeks prior to Baseline Visit (Visit 1) or anticipated use at any time during the study; known allergy or hypersensitivity to the study medications or their components; previous enrollment in an Ozurdex® clinical trial or previous use of an Ozurdex® implant.

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Group 1<br>Active bevacizumab (Avastin®) and Sham Ozurdex® | Drug: Active bevacizumab and Sham dexamethasone<br>* Bevacizumab: 25 mg/mL, PRN dosing Sham dexamethasone intravitreal implant: blunt needling of the sclera with no penetration of the globe<br>* Other names: Ozurdex® (dexamethasone intravitreal implant);|
| Active Comparator: Group 2<br>Active bevacizumab (Avastin®) and Active Ozurdex® | Drug: Active bevacizumab and Active dexamethasone<br>* Bevacizumab: 25 mg/mL, PRN dosing Dexamethasone intravitreal implant: 0.7 mg, single dose<br>* Other names: Ozurdex® (dexamethasone intravitreal implant);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Primary Efficacy Endpoint is the Total Number of PRN Bevacizumab Intravitreal Injections Through 24 Weeks |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Secondary Efficacy Endpoint is the Visual Acuity Score Based on Best Corrected Visual Acuity (BCVA) at Week 24 | Change in BCVA at Week 24 from baseline | 24 weeks |