Comparing the effectiveness and costs of bevacizumab to ranibizumab in patients with retinal vein occlusions
Phase 3
Completed
- Conditions
- Macular edema secondary to a retinal vein occlusion10047060
- Registration Number
- NL-OMON46979
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 228
Inclusion Criteria
* Male or female patients > 18 years of age with recent vision loss due to foveal center-involved ME secondary to branch or central retinal vein occlusion who, in the opinion of the investigator, could have functional benefit from injections with a VEGF antagonist, and who have signed an informed consent.
* BCVA > 24 and < 78 letters in the study eye and, inclusively, using ETDRS- like visual acuity testing charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/32 to 20/320) at screening.
* Mean central subfield thickness > 275 µm from 2 OCT measurements
Exclusion Criteria
see also protocol 4.4
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary study parameter is the mean change in best corrected visual acuity<br /><br>after 6 months compared to baseline.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Amongst others:<br /><br>The proportion of patients with a decrease of the best corrected visual acuity<br /><br>less than 15 letters on the EDTRS chart at 6 months compared to baseline.<br /><br>The proportion of patients with a decrease of the best corrected visual avuity<br /><br>of 15 letters or more on the EDTRS chart at 6 months compared to baseline.<br /><br><br /><br>For the full listings we refer to the protocol chapter 7.1 study endpoints</p><br>