Non-proliferative diabetic retinopathy Eye Diseases
Conditions
Interventions
The participants were randomized approximately 1:1:1 to three groups by a random number table. The participants in the Qiming granule group receive Qiming granules (Zhejiang Wansheng Pharmaceutical Co
Sponsors
First Affiliated Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years old (including boundary value) 2. Patients diagnosed with Type 2 diabetes(according to 1999 WHO criterion) 3. Patients with non-proliferative diabetic retinopathy (NPDR) (According to fundus photography and International Clinical Classification Standard for diabetes Retinopathy (2002)) 4. Subjects were treated with stable hypoglycemic drugs for at least 3 months 5. Subjects signed informed consent
Exclusion criteria
Exclusion criteria: 1. Subjects with other non-diabetic eye diseases interfering with fundus examination results (such as glaucoma, cataract, non-diabetic hemorrhagic eye disease, uveitis, retinal detachment, optic nerve disease, refractive stromal abnormalities, etc.) 2. Subjects with proliferative retinopathy (PDR) 3. glycosylated hemoglobin (HbA1C)>8.0% 4. Subjects with diabetic retinopathy caused by type 1 and special types of diabetes 5. Subjects who underwent eye surgery or treatment within 6 months 6. Subjects with central nervous system diseases 7. Subjects suffering from allergic diseases or allergic to this medicine 8. Subjects participated in other drugs trials within 3 months 9. Subjects were treated with drugs for diabetic retinopathy 10. Uncontrolled hypertension or untreated hypertension(defined as systolic blood pressure(SBP)>160mmHg or diastolic blood pressure(DBP)>100mmHg during screening) 11. Severe systemic diseases (such as cardiovascular system, respiratory system, digestive system, nervous system, endocrine system, genitourinary system diseases, etc.), malignant tumors, mental diseases and other diseases that may interfere with the results of this study 12. Impaired liver function, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level = 2.5 times the upper limit of normal value 13. Renal insufficiency (eGFR<45ml/min) 14. Women who are pregnant, breastfeeding or preparing for pregnancy 15. Subjects suffering from cancer requiring treatment in the past five years or expected to die within five years 16. Unwilling to sign informed consent 17. Subjects who cannot take medication as planned, and those who are unwilling or unable to accept regular visits
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Peripapillary retinal nerve fiber layer (pRNFL) thickness measured using optical coherence tomography angiography (OCTA) at baseline and 24 weeks 2. Corneal nerve fiber length (CNFL) measured using corneal confocal microscopy (CCM) at baseline and 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Corneal nerve fiber density (CNFD) and corneal nerve branch density (CNBD) measured using CCM at baseline and 24 weeks 2. Foveal avascular zone (FAZ) area measured using OCTA at baseline and 24 weeks 3. Best corrected visual acuity ( BCVA) measured using international standard vision chart at baseline and 24 weeks | — |
Countries
China
Contacts
Public ContactKun Yang
Outcome results
None listed