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

This study is currently recruiting participants.
Verified February 2013 by Texas Retina Associates
Sponsor:
Information provided by (Responsible Party):
Karl Csaky, Texas Retina Associates
ClinicalTrials.gov Identifier:
NCT01295112
First received: February 10, 2011
Last updated: February 5, 2013
Last verified: February 2013
History of Changes
  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 + Sham dexamethasone
Drug: Active bevacizumab + Active dexamethasone
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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:

U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 68
Study Start Date: May 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Group 1
Active bevacizumab (Avastin®) + Sham Ozurdex®
 Drug: Active bevacizumab + 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®) + Active Ozurdex®
 Drug: Active bevacizumab + 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01295112

Contacts
Contact: Karl G Csaky, MD, PhD 214-692-6941 kcsaky@texasretina.com
Contact: Diana Jaramillo 214-692-6941 ext 1 djaramillo@texasretina.com

Locations
United States, Texas
Texas Retina Associates Recruiting
Dallas, Texas, United States, 75231
Contact: Diana Jaramillo         djaramillo@texasretina.com    
Sponsors and Collaborators
Texas Retina Associates
Investigators
Principal Investigator: Karl Csaky, MD Texas Retina Associates
  More Information

No publications provided

Responsible Party: Karl Csaky, Prinicipal Investigator, Texas Retina Associates
ClinicalTrials.gov Identifier: NCT01295112     History of Changes
Other Study ID Numbers: TRA-OZAB-11-001
Study First Received: February 10, 2011
Last Updated: February 5, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Retinal Vein Occlusion
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Bevacizumab
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
 Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013