Macular edema secondary to a retinal vein occlusion
Conditions
Interventions
Bevacizumab 1.25 mg and ranibizumab 0.5mg are administered as monthly
intravitreal injections for 6 months to patients with macular edema secondary
to a retinal vein occlusion.
During the study visu
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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 275 µm from 2 OCT measurements
Exclusion criteria
Exclusion criteria: see also protocol 4.4
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study parameter is the mean change in best corrected visual acuity after 6 months compared to baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Amongst others: The proportion of patients with a decrease of the best corrected visual acuity less than 15 letters on the EDTRS chart at 6 months compared to baseline. The proportion of patients with a decrease of the best corrected visual avuity of 15 letters or more on the EDTRS chart at 6 months compared to baseline. For the full listings we refer to the protocol chapter 7.1 study endpoints | — |
Countries
Netherlands
Outcome results
None listed