diabetic macula edema
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1)stable medication for the management of diabetes within 3 months 2)visual impairment due to focal or diffuse DME 3)decreased vision due to DME and not other causes
Exclusion criteria
Exclusion criteria: 1)concomitant conditions in the study eye that could prevent the improvement in VA on the study 2)active intraocular inflammation or infection in either eye 3)uncontrolled glaucoma in either eye 4)treatment with antiangiogenic drugs in the study eye within 3 months before randomization 5)history of stroke and systolic blood pressure>160mmHg or diastolic BP>100mmHg,untreated hypertension, or change in antihypertensive treatment within 3 months preceding baseline.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| visual acuity improvement, central macula thickness, number of intravitreal renibizumab injections | — |
Secondary
| Measure | Time frame |
|---|---|
| intra ocular pressure, plasma levels of vascular endothelial growth factor(VEGF), aqueous concentrations of various cytokines, blood pressure | — |
Countries
Japan
Contacts
Shinshu university school of medicine Department of Ophthalmology