Expired Study
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Dallas, Texas 75231


Purpose:

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.


Study summary:

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.


Criteria:

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. 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.


Study is Available At:


Original ID:

TRA-OZAB-11-001


NCT ID:

NCT01295112


Secondary ID:


Study Acronym:


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


Overall Status:

Completed


Study Phase:

Phase 2/Phase 3


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Texas Retina Associates


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

68


Enrollment Type:

Actual


Overall Contact Information

Official Name:Karl Csaky, MD
Principal Investigator
Texas Retina Associates

Study Dates

Start Date:May 2011
Completion Date:October 2015
Completion Type:Actual
Primary Completion Date:October 2015
Primary Completion Type:Actual
Verification Date:September 2017
Last Changed Date:September 17, 2017
First Received Date:February 10, 2011
First Results Date:August 3, 2017

Study Outcomes

Outcome Type:Primary Outcome
Measure:The Primary Efficacy Endpoint is the Total Number of PRN Bevacizumab Intravitreal Injections Through 24 Weeks
Time Frame:24 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:The Secondary Efficacy Endpoint is the Visual Acuity Score Based on Best Corrected Visual Acuity (BCVA) at Week 24
Time Frame:24 weeks
Safety Issues:False
Description:Change in BCVA at Week 24 from baseline

Study Interventions

Intervention Type:Drug
Name:Active bevacizumab and Active dexamethasone
Description:Bevacizumab: 25 mg/mL, PRN dosing Dexamethasone intravitreal implant: 0.7 mg, single dose
Arm Name:Group 2
Other Name:Avastin® (bevacizumab)
Intervention Type:Drug
Name:Active bevacizumab and Sham dexamethasone
Description:Bevacizumab: 25 mg/mL, PRN dosing Sham dexamethasone intravitreal implant: blunt needling of the sclera with no penetration of the globe
Arm Name:Group 1
Other Name:Avastin® (bevacizumab)

Study Arms

Study Arm Type:Active Comparator
Arm Name:Group 2
Description:Active bevacizumab (Avastin®) and Active Ozurdex®
Study Arm Type:Sham Comparator
Arm Name:Group 1
Description:Active bevacizumab (Avastin®) and Sham Ozurdex®

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Texas Retina Associates

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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