Diabetic Macula Edema
Conditions
Brief summary
The purpose of this study is to evaluate the mean gain in best corrected visual acuity and the number of intravitreal ranibizumab (IVR) injections under the combination treatment of IVR, focal/grid laser and panretinal photocoagulation. Our hypothesis is that suitable photocoagulation decreases the number of IVR injections.
Interventions
PROCEDUREPhotocoagulation
Photocoagulation include focal/grid laser and/or panretinal photocoagulation
DRUGRanibizumab
Sponsors
Shinshu University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* stable medication for the management of diabetes within 3 months * visual impairment due to focal or diffuse diabetic macula edema * decreased vision due to diabetic macula edema and not other causes
Exclusion criteria
* concomitant conditions in the study eye that could prevent the improvement in VA on the study * active intraocular inflammation or infection in either eye * uncontrolled glaucoma in either eye * treatment with antiangiogenic drugs in the study eye within 3 months * history of stroke and uncontrolled hypertension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| best corrected visual acuity | every month, up to 36 months | Best corrected visual acuity is measured with Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and analysed. |
Countries
Japan
Outcome results
None listed