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

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

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 Overview

• Status: Completed
• Conditions: Non-Ischemic Central Retinal Vein Occlusion
• Intervention / Treatment: Drug: Active bevacizumab and Sham dexamethasone; Drug: Active bevacizumab and Active dexamethasone

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 Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75231
      • Texas Retina Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Group 1; Active bevacizumab (Avastin®) and Sham Ozurdex®	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; Other Names: Avastin® (bevacizumab); Ozurdex® (dexamethasone intravitreal implant)
Active Comparator: Group 2; Active bevacizumab (Avastin®) and Active Ozurdex®	Drug: Active bevacizumab and Active dexamethasone; Bevacizumab: 25 mg/mL, PRN dosing Dexamethasone intravitreal implant: 0.7 mg, single dose; Other Names: Avastin® (bevacizumab); Ozurdex® (dexamethasone intravitreal implant)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The Primary Efficacy Endpoint is the Total Number of PRN Bevacizumab Intravitreal Injections Through 24 Weeks	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Texas Retina Associates
• Investigators: Principal Investigator: Karl Csaky, MD, Texas Retina Associates

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: February 10, 2011
• First Submitted That Met QC Criteria: February 11, 2011
• First Posted (Estimate): February 14, 2011

Study Record Updates

• Last Update Posted (Actual): October 18, 2017
• Last Update Submitted That Met QC Criteria: September 17, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Retinal Diseases; Embolism and Thrombosis; Venous Thrombosis; Thrombosis; Retinal Vein Occlusion; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Dexamethasone; Dexamethasone acetate; BB 1101; Bevacizumab
• Other Study ID Numbers: TRA-OZAB-11-001