diabetic macular edema
Conditions
Interventions
Bevacizumab 1.25 mg and ranibizumab 0.5mg are administered as monthly
intravitreal injections for 6 months to patients with diabetic macular edema.
During the study visual acuity will be measured, sa
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Male or female patients > 18 years of age who have signed an Informed Consent. * Patients with Type 1 or Type 2 diabetes mellitus (according to American Diabetes Association or World Health Organization (WHO) guidelines) with glycosylated haemoglobin (HbA1c) less than 12.0% at screening (Visit 1). Patients should be on a dietary, exercise and/or pharmacological program for diabetes. Treatment for diabetes must have been stable for at least 2 months * Patients with visual impairment due to DME (within the EDTRS criteria of clinically significant macular edema) in at least one eye, with a central area thickness >325 micron, who are eligible for anti-VEGF treatment according to the investigator. If both eyes are eligible, the one with the worse visual acuity, as assessed at Visit 1, will be selected by the investigator as the study eye. * BCVA equal or more than 24 and less or equal to 78 letters in the study eye and, inclusively, using ETDRS- like visual acuity testing charts at a testing distance of 4 meter (approximate Snellen equivalent of 20/32 to 20/320) at screening. * Concomitant conditions in the study eye which, in the opinion of the investigator, do not prevent improvement of visual acuity on study treatment
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 acuity 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