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

Non-Ischemic Central Retinal Vein Occlusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01295112
• Other study ID #: TRA-OZAB-11-001
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 10, 2011
• Last updated: September 17, 2017
• Start date: May 2011
• Est. completion date: October 2015

Study information

• Verified date: September 2017
• Source: Texas Retina Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Non-Ischemic Central Retinal Vein Occlusion
• Retinal Vein Occlusion

Intervention

Drug:
• Active bevacizumab and Sham dexamethasone
Bevacizumab: 25 mg/mL, PRN dosing Sham dexamethasone intravitreal implant: blunt needling of the sclera with no penetration of the globe
• Active bevacizumab and Active dexamethasone
Bevacizumab: 25 mg/mL, PRN dosing Dexamethasone intravitreal implant: 0.7 mg, single dose

Locations

Country	Name	City	State
United States	Texas Retina Associates	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Retina Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Primary Efficacy Endpoint is the Total Number of PRN Bevacizumab Intravitreal Injections Through 24 Weeks		24 weeks
Secondary	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