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

Information source: Texas Retina Associates
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Non-Ischemic Central Retinal Vein Occlusion

Intervention: Active bevacizumab and Sham dexamethasone (Drug); Active bevacizumab and Active dexamethasone (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Texas Retina Associates

Official(s) and/or principal investigator(s):
Karl Csaky, MD, Principal Investigator, Affiliation: Texas Retina Associates

Overall contact:
Karl G Csaky, MD, PhD, Phone: 214-692-6941, Email: kcsaky@texasretina.com

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.

Clinical Details

Official title: Effect of Ozurdex« 0.7 mg on Improvement of Efficacy of Bevacizumab Therapy for Non-Ischemic Central Retinal Vein Occlusion

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: The primary efficacy endpoint is the total number of PRN bevacizumab intravitreal injections through 24 weeks

Secondary outcome: The secondary efficacy endpoint is the visual acuity score based on best corrected visual acuity (BCVA) at Week 24

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Karl G Csaky, MD, PhD, Phone: 214-692-6941, Email: kcsaky@texasretina.com

Texas Retina Associates, Dallas, Texas 75231, United States; Recruiting
Diana Jaramillo, Email: djaramillo@texasretina.com
Additional Information

Starting date: May 2011
Last updated: April 20, 2015

Page last updated: August 23, 2015

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