Effect of Ozurdex® 0.7 mg on Improvement of Efficacy of Bevacizumab Therapy for Non-Ischemic Central Retinal Vein Occlusion
Overview
- Phase
- Phase 2
- Intervention
- Active bevacizumab and Sham dexamethasone
- Conditions
- Non-Ischemic Central Retinal Vein Occlusion
- Sponsor
- Texas Retina Associates
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- The Primary Efficacy Endpoint is the Total Number of PRN Bevacizumab Intravitreal Injections Through 24 Weeks
- Status
- Completed
- Last Updated
- 7 months ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Group 1
Active bevacizumab (Avastin®) and Sham Ozurdex®
Intervention: Active bevacizumab and Sham dexamethasone
Group 2
Active bevacizumab (Avastin®) and Active Ozurdex®
Intervention: Active bevacizumab and Active dexamethasone
Outcomes
Primary Outcomes
The Primary Efficacy Endpoint is the Total Number of PRN Bevacizumab Intravitreal Injections Through 24 Weeks
Time Frame: 24 weeks
Secondary Outcomes
- The Secondary Efficacy Endpoint is the Visual Acuity Score Based on Best Corrected Visual Acuity (BCVA) at Week 24(24 weeks)