Phase 3
N=68
Effect of Ozurdex® 0.7 mg on Improvement of Efficacy of Bevacizumab for Central Retinal Vein Occlusion
Non-Ischemic Central Retinal Vein Occlusion
Bottom Line
View on ClinicalTrials.gov: NCT01295112 ↗Enrolled (actual)
68
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcome: Primary: The Primary Efficacy Endpoint is the Total Number of PRN Bevacizumab Intravitreal Injections Through 24 Weeks — 5; 19; 13; 11 Participants — p=0.00002
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Active bevacizumab and Sham dexamethasone (Drug); Active bevacizumab and Active dexamethasone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Texas Retina Associates
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Efficacy Endpoint is the Total Number of PRN Bevacizumab Intravitreal Injections Through 24 Weeks |
5; 19; 13; 11; 10; 3 | 0.00002 sig |
| SECONDARY The Secondary Efficacy Endpoint is the Visual Acuity Score Based on Best Corrected Visual Acuity (BCVA) at Week 24 |
16.20; 13.55 | 0.53 |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01295112). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.