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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01295112
First Posted: February 14, 2011
Last Update Posted: October 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Karl Csaky, Texas Retina Associates
  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.

Condition Intervention Phase
Non-Ischemic Central Retinal Vein Occlusion Drug: Active bevacizumab and Sham dexamethasone Drug: Active bevacizumab and Active dexamethasone Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Ozurdex® 0.7 mg on Improvement of Efficacy of Bevacizumab Therapy for Non-Ischemic Central Retinal Vein Occlusion

Resource links provided by NLM:


Further study details as provided by Karl Csaky, Texas Retina Associates:

Primary Outcome Measures:
  • The Primary Efficacy Endpoint is the Total Number of PRN Bevacizumab Intravitreal Injections Through 24 Weeks [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • The Secondary Efficacy Endpoint is the Visual Acuity Score Based on Best Corrected Visual Acuity (BCVA) at Week 24 [ Time Frame: 24 weeks ]
    Change in BCVA at Week 24 from baseline


Enrollment: 68
Study Start Date: May 2011
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01295112


Locations
United States, Texas
Texas Retina Associates
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Texas Retina Associates
Investigators
Principal Investigator: Karl Csaky, MD Texas Retina Associates
  More Information

Responsible Party: Karl Csaky, Prinicipal Investigator, Texas Retina Associates
ClinicalTrials.gov Identifier: NCT01295112     History of Changes
Other Study ID Numbers: TRA-OZAB-11-001
First Submitted: February 10, 2011
First Posted: February 14, 2011
Results First Submitted: August 3, 2017
Results First Posted: October 18, 2017
Last Update Posted: October 18, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Retinal Vein Occlusion
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Dexamethasone acetate
Dexamethasone
Bevacizumab
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors