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

Texas Retina Associates

Status and phase: Completed; Phase 3; Phase 2

Conditions: Non-Ischemic Central Retinal Vein Occlusion

Treatments: Drug: Active bevacizumab and Active dexamethasone; Drug: Active bevacizumab and Sham dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT01295112

TRA-OZAB-11-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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68 participants in 2 patient groups

Group 1

Sham Comparator group

Description:

Active bevacizumab (Avastin®) and Sham Ozurdex®

Treatment:

Drug: Active bevacizumab and Sham dexamethasone

Group 2

Active Comparator group

Description:

Active bevacizumab (Avastin®) and Active Ozurdex®

Treatment:

Drug: Active bevacizumab and Active dexamethasone