diabetic macular edema
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria for type 2 diabetes, diagnosed with macular edema by OCT or FFA, aged 18 to 75 years, and gender is not limited; 2. No acute complications of diabetes (diabetic hyperglycemia and hyperosmolar state, diabetic ketoacidosis, etc.), fasting blood glucose <= 10mml/L, blood pressure <= 150/90 mmHg; 3. TCM syndrome differentiation is deficiency of both qi and yin, dampness and blood stasis blocking collaterals; 4. Informed consent, volunteer experiment. The process of obtaining informed consent should comply with GCP regulations.
Exclusion criteria
Exclusion criteria: 1. History of ocular trauma, vitreous surgery, glaucoma, uveitis or other retinal diseases found in FFA examination; 2. Recent history of myocardial infarction, cerebral infarction and other serious systemic diseases and severe refractive interstitial opacities that affect fundus observation; 3. Patients with diabetic macular edema who have received intravitreal or peribulbar injection of glucocorticoids; 4. Poor image quality cannot complete image analysis; 5. Thromboembolism, abnormal coagulation function, using anticoagulant drugs (except aspirin), or a history of other serious systemic diseases; 6. Those who cannot give fully informed consent due to intellectual or behavioral barriers; 7. Suspect or have a history of alcohol or drug abuse; 8. According to the judgment of the investigator, other diseases that reduce the possibility of enrolling or complicate enrollment, such as frequent changes in the working environment, are likely to cause loss to follow-up; 9. Allergic constitution, such as those with a history of two or more drug or food allergies; or those who are known to be allergic to the ingredients of this medicine; 10. Patients who are participating in clinical trials of other drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| central Retinal thickness;best corrected vision acuity; | — |
Secondary
| Measure | Time frame |
|---|---|
| superficial capillary plexus-retinal vascular density; | — |
Countries
China
Contacts
Affiliated Hospital of Nanjing University of Chinese Medicine