Diabetic macula edema
Conditions
Interventions
Aflibercept (genetical recombination) will be administered by intravitreal injection at a dose of 2 mg (0.05 mL) at intervals of at least 1 month.
Sponsors
Shinshu University Department of ophthalmology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with type 1 or type 2 diabetes mellitus 20 years of age or older Patients with fovea involving diabetic macular edema (judged with central subfield thickness on OCT) Patients with reduced visual acuity associated with diabetic macular edema Patients whose best corrected visual acuity is more than 20/320 (24 letters) by the ETDRS visual acuity test. Patients with a central retinal thickness (CRT) of 300 um or more on the OCT retinal map (measured in mm) as an objective finding Patients who are willing and able to visit the study site, as scheduled, and undergo scheduled examinations in this study Patients who can provide written voluntary consent to participate in this study after receiving adequate explanation
Exclusion criteria
Exclusion criteria: The condition of the fellow eye is worse than that of the study eye. A history of vitreous surgery, including encircling buckling Any retinal photocoagulation treatment within 90 days Topical corticosteroid treatment within 120 days Treatment with injection of any anti VEGF agent into the study eye within 90 days Highly active, proliferative diabetic retinopathy in the study eye A history of uveitis Aphakic eyes A history of any intraocular surgery in the study eye within the previous 90 days It is considered difficult to improve visual acuity due to morphological changes Glaucoma with poor IOP control, a history of glaucoma filtering surgery, or scheduled filtering surgery in the study eye IOP of the study eye: more than 25 mmHg Myopia of -8D or greater Optic media in which it is difficult to obtain fundus photographs or OCT images Severe systemic infections at baseline Systemic anticoagulation therapy within 180 Poorly controlled diabetes mellitus Poorly controlled hypertension A history of cerebrovascular accident and/or myocardial infarction within 180 days Patients on dialysis and patients with renal failure requiring dialysis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Central retinal thickness (CRT) measured on optical coherence tomography (OCT) and visual acuity | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of intravitreal injections of aflibercept and safety | — |
Countries
Japan
Contacts
Public ContactTakao Hirano
Shinshu University Department of ophthalmology
Outcome results
None listed