Diabetic retinopathy
Conditions
Interventions
experimental group:Zaltrap Injection Combined with Compound Danshen Dropping Pills for oral administration
control group:Zaltrap Injection
Sponsors
Xi 'an People's Hospital (Xi 'an Fourth Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Sign an informed consent form and conduct follow-up according to the time specified in the trial; 2. Patients with type 2 diabetes whose age is>=18 years old, regardless of gender; 3. Clinical diagnosis of stage II-III NPDR and stage IV non high-risk PDR patients with concomitant CI-DME and no indication for PPV surgery; 4. The target eye must meet the following requirements: 4.1 ETDRS vision chart measures BCVA of = 73 letters at a distance of 4 meters/1 meter (equivalent to 20/40 of Snellen vision chart); 4.2 Reference Protocol T protocol, OCT examination shows central retinal thickness (CRT) = 320µm (male) or 305µm (female) (using Heidelberg spectrodomain OCT); 4.3 Refractive medium opacity and pupil shrinkage that do not affect fundus examination.
Exclusion criteria
Exclusion criteria: Individuals with any of the following eye conditions 1. There is relative pupillary blockade; Previously underwent radial optic nerve or sheath incision surgery; 2. The target eye or systemic system has received anti VEGF drug treatment within 3 months prior to screening; 3. The target eye has used corticosteroids in the eye or around the eye within 3 months, or has used corticosteroids throughout the body (oral, muscular, intravenous) within one month; 4. The target eye has undergone the following ophthalmic vitreoretinal surgeries (PPV, PDT, macular transposition, subcontral photocoagulation, parafoveal laser photocoagulation, macular grid like photocoagulation, PRP, etc.) and other subcontral surgeries within 3 months; 5. The target eye has undergone YAG laser surgery within one month or any other ophthalmic surgery (including cataract extraction, scleral buckling, corneal transplantation, etc.) within three months; 6. The target eye and/or the opposite eye have active eye infections (such as blepharitis, infectious conjunctivitis, keratitis, scleritis, endophthalmitis, etc.); 7. Patients with a history of any type of retinal detachment or tear involving the macula, pre retinal fibrosis involving the macular area, history of Toxoplasma gondii, vascular stripe like changes, pathological myopia, etc. in the target eye; 8. There is obvious vitreous hemorrhage involving the fovea, and the researchers believe that this bleeding is the main cause of visual impairment in patients; 9. Previous or current uncontrolled glaucoma (defined as intraocular pressure still greater than 25mm Hg after anti glaucoma treatment), or severe glaucoma causing the target eye to have a fovea/optic disc ratio greater than 0.8, or the target eye having undergone glaucoma filtering surgery; 10. Suffering from other diseases that researchers believe will affect the recovery of macular edema, such as macular membrane, vitreous macular traction, foveal atrophy, dense subcontral hemorrhage, changes in the dense pigment layer, or dense subcontral exudate; 11. Researchers believe that non DR eye diseases that may cause macular edema, decreased vision, or the formation of retinal neovascularization during the study period, such as wet or dry AMD, RVO, uveitis or other intraocular inflammatory diseases, neovascular glaucoma, Owen Gais syndrome, and vitreous macular traction, etc; 12. Any eye with iris neovascularization or neovascular glaucoma at baseline; 13. Researchers believe that cataract patients who may experience a decrease in vision of 3 rows or more, or whose target eye requires medication or surgical treatment within the past 4 months; 14. Individuals who have an allergic reaction or history to fluorescein sodium, a history of allergies to therapeutic or diagnostic protein products, and allergies to more than two (including two) drugs and/or non drug factors, or are currently suffering from allergic diseases 15. Screening for individuals with a history of myocardial infarction and/or cerebrovascular disease, temporary cerebral ischemia, active disseminated intravascular coagulation, and obvious bleeding tendency within the first 6 months; 16. Screening for individuals who have participated in any clinical trial of drugs (excluding vitamins and minerals) within the first 3 months (if the half-life of the investigational drug is longer than 3 months, then 5 half-lives); 17. Researchers believe that systemic medications currently in use or potentially needed to t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BCVA;IOP;OCT;OCTA; | — |
Secondary
| Measure | Time frame |
|---|---|
| Wide-angle OCT;FFA;Liver and kidney function;blood coagulation; | — |
Countries
China
Contacts
Public ContactZhang yanchun
Xi 'an People's Hospital (Xi 'an Fourth Hospital)
Outcome results
None listed