Diabetic macular edema in adults
Conditions
Interventions
Aflibercept for Treatment of Diabetic Macular Edema in Adults:none
Sponsors
Shaanxi Triffic Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Macular edema secondary to type 1 or type 2 diabetes and detected by optical coherence tomography (OCT) The study involved the macular center of the eye (fovea), which was confirmed by reading the film center during screening. 2. Age > 18 years old, gender unlimited; 3. The subfoveal retinal thickness of the affected eye was evaluated by OCT to be = 300µm, which was confirmed by the film center during screening. 4. Intravitreal injection of arbocept was used to treat DME; 5. Complete and complete case data; 6. Patients or their families give informed consent to this protocol.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. DME with vitreous hemorrhage or other fundus diseases such as retinal detachment, retinal vein obstruction or macula Denaturation; 3. History of vitreoretinal surgery, cataract surgery, systemic anti-VEGF therapy, eyes within 6 months before treatment History of internal implant therapy; 4. History of intraocular anti-VEGF therapy, ocular hormone use, and panretinal photocoagulation within 3 months before treatment; 5. The target eye has uncontrollable glaucoma (intraocular pressure is still =25mmHg after drug treatment) or has glaucoma filtration surgery History; 6. Diagnosis or suspected intraocular/periocular infection and inflammation; 7. The presence of neovascular glaucoma and the presence of cataract and other refractive interstitial opacity affected the fundus observers; 8. Serious systemic diseases (such as serious cardiovascular diseases, kidney diseases, etc.) and other eye diseases The judgment of the result; 9. The investigator considers that there are other conditions that are not suitable for participation in clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference between the best corrected visual acuity 1 month after drug injection and the baseline data before treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Macular central area thickness (CMT) at 1 month after injection compared with baseline data before treatment;Macular foveal retinal thickness (CFT) 1 month after drug injection compared with baseline data before treatment;Intraocular pressure 1 month after drug injection and difference from baseline data before treatment;Incidence of treatment-related complications and drug-related adverse events during the study period; | — |
Countries
China
Contacts
Public ContactZhang Hengqiang
Shaanxi Triffic Hospital
Outcome results
None listed