Diabetic Retinopathy
Conditions
Interventions
Intervention Group:Shuangdan Mingmu Capsule
Control Group:Placebo for Shuangdan Mingmu Capsule
Sponsors
Tianjin Medical University Eye Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Patients diagnosed with diabetic retinopathy. 2) Scheduled to undergo panretinal photocoagulation in the near future. 3) Best-corrected visual acuity (BCVA) of = 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (at 4 meters, equivalent to Snellen visual acuity of 20/125, or 0.16). 4) Any medications used to treat concomitant diseases should have been stable for 3 months prior to randomization and are expected to remain stable (medically acceptable) throughout the study. 5) Aged between 18 and 75 years. 6) Voluntary participation with signed informed consent.
Exclusion criteria
Exclusion criteria: 1) History of other ophthalmic surgeries in the recent past, such as cataract surgery, glaucoma surgery, or vitreoretinal surgery. 2) Presence of other ocular diseases affecting visual acuity, such as glaucoma, retinal artery or vein occlusion, non-diabetic retinopathy, retinal detachment, uveitis, corneal ulcer, etc. 3) Presence of cataracts, optic nerve diseases, or high myopia with fundus changes that could interfere with fundus examination. 4) Known allergy to any component of Shuangdan Mingmu Capsules. 5) Poor glycemic control, defined as fasting blood glucose (FBG) = 10.0 mmol/L or glycated hemoglobin = 8%. 6) Diagnosis of diabetes mellitus other than type 2 diabetes. 7) Use of intravitreal anti-VEGF antibodies or glucocorticoids within 3 months prior to enrollment. 8) Use of medications explicitly indicated for diabetic retinopathy in their package inserts, such as calcium dobesilate, pancreatic kininogenase, Qiming Granules, or Compound Danshen Dripping Pills, within 2 weeks prior to enrollment. 9) Presence of other severe systemic diseases or complications, such as poorly controlled hypertension (including but not limited to grade 2 or higher hypertension), severe heart disease (e.g., myocardial infarction within 3 years prior to enrollment), abnormal liver function tests (ALT and/or AST = 1.5 times the upper limit of normal), severe kidney disease (e.g., azotemia stage, uremia stage), or diabetic foot. 10) Occurrence of acute diabetic complications (e.g., diabetic ketoacidosis, hyperglycemic hyperosmolar syndrome, diabetic lactic acidosis) within 1 year prior to the screening period. 11) Suspected or confirmed allergy to diagnostic agents used in the study (e.g., contrast media, mydriatics). 12) Heavy smokers (more than 20 cigarettes per day). 13) Suspected or confirmed history of alcohol abuse, drug abuse, or substance abuse. 14) Women who are pregnant, planning to become pregnant, or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best corrected visual acuity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Intraocular Pressure ;Number of microaneurysms;Macular foveal thickness;retinal total circulation time;Tear Film Break-Up Time; | — |
Countries
China
Contacts
Public ContactBincui Cai
Tianjin Medical University Eye Hospital
Outcome results
None listed