None listed
Conditions
Interventions
Drug : Administration of this drug 2.0mg (0.05ml) is recommended. The drug is contained in one glass vial, and it must be used only for one intravitreal administration, not divided doses. Intravitreal
Sponsors
Kyung Hee University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with type 1 or type 2 diabetes over the age of 20 who have signed the informed consent form 2. Patients with diabetic macular edema that invaded the fovea; when the average retinal thickness in a concentric circle with a diameter of 1 mm centered on the fovea measured by optical coherence tomography (SD-OCT) is 300 µm or more 3. If the best corrected visual acuity (BCVA) of the patients is 24 or more 4. Patients who understand the process of this clinical trial, are cooperative, and are judged to be able to participate by the end of the clinical trial
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women 2. Patients participating in other clinical trials 3. In case of receiving anti-vascular endothelial growth factor treatment within the last 3 months 4. If the test subject has received steroid injection treatment within the last 6 months 5. In case of active proliferative diabetic retinopathy, iris neovascularization, vitreous hemorrhage, or traction retinal detachment in the subject 6. If the subject has active or past uveitis 7. History of intraocular surgery including cataract, vitrectomy, glaucoma, and scleral buckling within the last 3 months (excluding simple refractive surgery and plastic surgery) 8. Patients with structural damage to the fovea, so that it is difficult to expect improvement in visual acuity even after treatment for macular edema (retinal pigment epithelial atrophy, subretinal fibrosis and scarring, etc.) 9. Patients who have retinal diseases other than diabetic macular edema and require surgery or treatment during the trial period (advanced glaucoma, retinal vessel occlusion, retinal detachment, macular hole, macular degeneration, etc.) 10. Cerebrovascular disease, myocardial infarction diagnosed within the last year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best corrected visual acuity | — |
Secondary
| Measure | Time frame |
|---|---|
| parameter of microvasculature, subfield thickness change, Diabetic Retinopathy Severity Scale (DRSS) | — |
Countries
Korea, Republic of
Contacts
Public ContactKyungSuk Yeo
Kyung Hee University Hospital
Outcome results
None listed