CompletedPhase 2/3

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

United States68 participantsStarted 2011-05

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. male or female subjects (aged 18 or older);
✓. provide written informed consent and sign/date a health information release;
✓. women of childbearing potential must be willing to practice effective contraception for the duration of the study.

Exclusion criteria

✕. 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;
✕. 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);
✕. 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);
✕. 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;
✕. known allergy or hypersensitivity to the study medications or their components;
✕. previous enrollment in an Ozurdex® clinical trial or previous use of an Ozurdex® implant.

What they're measuring

The Primary Efficacy Endpoint is the Total Number of PRN Bevacizumab Intravitreal Injections Through 24 Weeks

Timeframe: 24 weeks

Trial details

NCT IDNCT01295112

SponsorTexas Retina Associates

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-10

Results submitted2017-08-03

View on ClinicalTrials.gov More Non-Ischemic Central Retinal Vein Occlusion trials