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

Phase 2

Completed

• Conditions: Non-Ischemic Central Retinal Vein Occlusion
• Interventions: Drug: Active bevacizumab and Active dexamethasone; Drug: Active bevacizumab and Sham dexamethasone

• Registration Number: NCT01295112
• Lead Sponsor: Texas Retina Associates

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.

Study Timeline

• Study First Submitted: 2011-02-10
• Study First Submitted QC: 2011-02-11
• Study First Posted: 2011-02-14
• Study Start: 2011-05
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Results First Submitted: 2017-08-03
• Status Verified: 2017-09
• Results First Submitted QC: 2017-09-17
• Last Update Submitted: 2017-09-17
• Results First Posted: 2017-10-18
• Last Update Posted: 2017-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

1. male or female subjects (aged 18 or older);
2. provide written informed consent and sign/date a health information release;
3. women of childbearing potential must be willing to practice effective contraception for the duration of the study.

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Exclusion Criteria

1. 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;
2. 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);
3. 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);
4. 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;
5. known allergy or hypersensitivity to the study medications or their components;
6. previous enrollment in an Ozurdex® clinical trial or previous use of an Ozurdex® implant.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Active bevacizumab and Active dexamethasone	Active bevacizumab (Avastin®) and Active Ozurdex®
Group 1	Active bevacizumab and Sham dexamethasone	Active bevacizumab (Avastin®) and Sham Ozurdex®

Primary Outcome Measures

Name	Time	Method
The Primary Efficacy Endpoint is the Total Number of PRN Bevacizumab Intravitreal Injections Through 24 Weeks	24 weeks

Secondary Outcome Measures

Name	Time	Method
The Secondary Efficacy Endpoint is the Visual Acuity Score Based on Best Corrected Visual Acuity (BCVA) at Week 24	24 weeks	Change in BCVA at Week 24 from baseline

Trial Locations

Locations (1)

Texas Retina Associates; 🇺🇸 Dallas, Texas, United States