diabetic macular edema
Conditions
Interventions
experimental group:Qi-Deng Ming-Mu capsule
placebo group:Simulated capsule
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Signed informed consent and willing to follow up according to the time specified in the experiment; 2. Aged 18-70 years, no gender; 3. Diagnosed as type 2 diabetes, and glycosylated hemoglobin (HbA1c) value = 24 letters and = 300 µm (using spectral domain OCT); (4) No refractive fluid opacity and pupil dilation that affected fundus examination; 6. The subject's non-study eye has a BCVA >= 24 letters (equivalent to 20/320 of Snellen's vision); 7. Note: Each subject in the study can only be selected for one target eye. If both eyes meet the inclusion criteria, the lower eye of BCVA is enrolled. If the BCVA of both eyes is the same, the right eye is the study eye.
Exclusion criteria
Exclusion criteria: 1. Proliferative diabetic retinopathy (PDR) with vitreous hemorrhage or traction retinal detachment in the study eye; 2. Within 3 months prior to screening, any eye or systemic system has been treated with anti-VEGF drugs (such as aboxicept, compaqep, ranibizumab, bevacizumab, etc.), or any eye has been in the eye Injection of corticosteroids (such as triamcinolone acetonide), or intraocular injection of corticosteroids within 1 month prior to screening; 3. Drugs that have been used to treat diabetic retinopathy within 2 weeks prior to screening (defined as approved drugs for the treatment of diabetic retinopathy, such as QiMingkeli and ShuangDanMingMu capsule); 4. The study eye underwent panretinal photocoagulation within 6 months prior to screening. The study eye received >=2 local/grid retinal photocoagulation treatments, or received local/grid retinal photocoagulation within 3 months prior to screening; 5. The study eye had received an intraocular surgery within 3 months prior to screening; 6. Study eye combined with other eye diseases that affect vision, such as retinal vein occlusion, glaucoma, uveitis, optic neuropathy, retinal detachment, age-related macular degeneration (AMD), cataracts that affect fundus observation and vision, etc. 7. Impaired renal function (Crea is higher than the upper limit of the normal value of the laboratory in the center *1.5) or abnormal liver function (ALT, AST is higher than the upper limit of the normal value of the laboratory *2); 8. In the first 3 months of screening, blood glucose control is unstable (defined as changing from oral hypoglycemic therapy to insulin therapy, starting with insulin pump therapy or multiplying the number of daily insulin injections); 9. Uncontrollable hypertension (defined as systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 95 mmHg after antihypertensive drug treatment); 10. Now suffering from serious gastrointestinal diseases (active or gastrointestinal episodes, or doctors believe that medical intervention is required); 11. Have a history of allergies, allergies or allergic diseases in the same drug (including drugs containing jaundice, puerarin, and scutellaria); 12. Other drug clinical trials are underway, or clinical trials of any drug (excluding vitamins and minerals) have been taken within 3 months; 13. There are other clinical problems that are difficult to control (such as cancer, HIV, hepatitis C virus infection, active hepatitis B or other serious chronic infections, severe mental, neurological, cardiovascular, respiratory and other systemic diseases); 14. Patients of childbearing age (male/female) disagreed with the use of recognized effective contraceptives during the study period and at least 6 months after completion of the study, and/or women of childbearing age who were unwilling or unable to undergo a pregnancy test; 15. Pregnant or lactating women (where pregnancy is defined as a positive urine pregnancy test); 16. Researchers believe that exclusions are needed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in BCVA score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Central retinal thickness;Fundus area of retina;Hard exudation area;Soft exudation area;ETDRs classification; | — |
Countries
China
Contacts
Public ContactLong Pang
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed