Back to resultsEffect of Ozurdex® 0.7 mg on Improvement of Efficacy of Bevacizumab for Central Retinal Vein Occlusion
Primary Purpose
Non-Ischemic Central Retinal Vein Occlusion
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Active bevacizumab and Sham dexamethasone
Active bevacizumab and Active dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Non-Ischemic Central Retinal Vein Occlusion
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.
Sites / Locations
- Texas Retina Associates
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
Group 1
Group 2
Arm Description
Active bevacizumab (Avastin®) and Sham Ozurdex®
Active bevacizumab (Avastin®) and Active Ozurdex®
Outcomes
Primary Outcome Measures
The Primary Efficacy Endpoint is the Total Number of PRN Bevacizumab Intravitreal Injections Through 24 Weeks
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01295112
First Posted
February 10, 2011
Last Updated
September 17, 2017
Sponsor
Texas Retina Associates
1. Study Identification
Unique Protocol Identification Number
NCT01295112
Brief Title
Effect of Ozurdex® 0.7 mg on Improvement of Efficacy of Bevacizumab for Central Retinal Vein Occlusion
Official Title
Effect of Ozurdex® 0.7 mg on Improvement of Efficacy of Bevacizumab Therapy for Non-Ischemic Central Retinal Vein Occlusion
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Retina Associates
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Ischemic Central Retinal Vein Occlusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Sham Comparator
Arm Description
Active bevacizumab (Avastin®) and Sham Ozurdex®
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Active bevacizumab (Avastin®) and Active Ozurdex®
Intervention Type
Drug
Intervention Name(s)
Active bevacizumab and Sham dexamethasone
Other Intervention Name(s)
Avastin® (bevacizumab), Ozurdex® (dexamethasone intravitreal implant)
Intervention Description
Bevacizumab: 25 mg/mL, PRN dosing Sham dexamethasone intravitreal implant: blunt needling of the sclera with no penetration of the globe
Intervention Type
Drug
Intervention Name(s)
Active bevacizumab and Active dexamethasone
Other Intervention Name(s)
Avastin® (bevacizumab), Ozurdex® (dexamethasone intravitreal implant)
Intervention Description
Bevacizumab: 25 mg/mL, PRN dosing Dexamethasone intravitreal implant: 0.7 mg, single dose
Primary Outcome Measure Information:
Title
The Primary Efficacy Endpoint is the Total Number of PRN Bevacizumab Intravitreal Injections Through 24 Weeks
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
The Secondary Efficacy Endpoint is the Visual Acuity Score Based on Best Corrected Visual Acuity (BCVA) at Week 24
Description
Change in BCVA at Week 24 from baseline
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl Csaky, MD
Organizational Affiliation
Texas Retina Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Retina Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Ozurdex® 0.7 mg on Improvement of Efficacy of Bevacizumab for Central Retinal Vein Occlusion
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