diabetic macular edema
Conditions
Interventions
Sponsors
Eye Hospital, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1)Patients who diagnosed with type 2 diabetes and at least one eye all meet the following criteria; (2) 18-75 years old, regardless of gender; (3) Meet the diagnostic criteria for diabetic macular edema; OCT examination showed central retinal thickness (CRT) >=300 m. (4) The ETDRS best corrected visual acuity chart letter score 78-24 (20/32 to 20/320); (5) TCM syndrome differentiation belongs to spleen-kidney Yang deficiency combined with blood stasis; (6) Those who voluntarily sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) The refractive stroma is unclear, making it difficult to conduct fundus observation; (2) Patients who have received any or several therapeutic methods of intravitreal injection of triamcinolone, intravitreal injection of Avastin, or intravitreal injection of Lusentis, grille like laser or total retinal laser in the past 3 months; (3) The target eye has received intraocular surgery within 3 months before screening; (4) hemoglobin a1c (HbA1c) value > 10%; Impaired renal function (Crea is more than 1.5 times higher than the upper limit of the normal value of our laboratory) or abnormal liver function (ALT and AST are more than 2 times higher than the upper limit of the normal value of our laboratory); (5) Combined with glaucoma, retinal vein occlusion, uveitis, optic nerve disease and other ocular fundus diseases; (6) Patients with severe cardiovascular and cerebrovascular, liver and hematopoietic diseases and diabetic nephropathy with renal failure; (7) patients with primary diseases and mental diseases that are seriously life-threatening; (8) Pregnant or lactating women, urine pregnancy test positive; (9) Participating in other drug clinical trials; (10) Failing to cooperate in the inspection process; (11) Failing to follow up the fundus examination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| central retina mean thickness;Macular volume; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fluorescence leakage of retinal capillary in macular area;Best corrected visual acuity;Number of glass cavity injections;The percentage of patients who need repeated injection of anti-VEGF drugs;TCM syndrom score;Target eye fundus lesions include retinal hemorrhage, hard exudate, soft exudate area; | — |
Countries
China
Contacts
Public ContactJie chuanghong
Eye Hospital, China Academy of Chinese Medical Sciences
Outcome results
None listed