Diabetic macula edema
Conditions
Interventions
Aflibercept will be administered by intravitreal injection at a dose of 2mg (0.05 mL) at intervals of at least 1 month.
Sponsors
Kyoto Prefecture University of Medicine Depertment of ophthalmology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients with type 1 or type 2 diabetes mellitus 20 years of age or older 2.Patients with fovea involving diabetic macular edema 3.Patients with reduced visual acuity associated with diabetic macular edema 4.Patients whose best corrected visual acuity is less than or equal to 6/10 5.Patients with a central retinal thickness (CRT) of 300 um or more on the OCT
Exclusion criteria
Exclusion criteria: 1.A history of vitreous surgery, including encircling buckling 2.Any retinal photocoagulation treatment or treatment with injection of any anti VEGF agent within 90 days 3.Highly active, proliferative diabetic retinopathy 4.A history of ocular inflammation 5.A history of any intraocular surgery within the previous 90 days 6.Aphakic eyes 7.Contrast medium allergy 8.It is considered difficult to improve visual acuity due to morphological changes 9.Glaucoma with poor IOP control,or IOP of the study eye: more than 25 mmHg 10.Myopia of -8D or greater 11.Severe systemic infections 12.Treatment with carcinostatic agent 13.Uncontrolled diabetes mellitus,as defined by HbA1c >12% 14.Uncontrolled blood pressure,defined as systolic >180 mmHg or diastolic >100 mmHg while subject is sitting) 15.A history of cerebrovascular accident and/or myocardial infarction within 180 days 16.Patients on dialysis and patients with renal failure requiring transplantation 17.Pregant or lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual acuity,central retinal thickness (CRT) measured on optical coherence tomography (OCT) | — |
Countries
Japan
Contacts
Public ContactHiroki Mieno
Kyoto Prefecture University of Medicine Depertment of ophthalmology
Outcome results
None listed