diabetic retinopathy
Conditions
Interventions
2:Intravitreal injection of Lucentis
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 years and elder; 2. Diagnosis of diabetes mellitus (type 1 or type 2); 3. The fundus color photography was graded by Reading Center as grade 47-53; 4. Patients have not received Pan Retinal Photocoagulation (PRP: laser spots on fundus outside hemal arch are less than 100); 5. HbA1C= 10%; 6. Media clarity and pupillary dilation sufficient to obtain adequate fundus examinations; 7. No central subfield macular edema.
Exclusion criteria
Exclusion criteria: 1) Ocular infection, including conjunctivitis, chalazion, or substantial blepharitis; 2) Proliferative diabetic retinopathy; 3) History of prior vitreous hemorrhage within 2 months; 4) An ocular condition is present (other than DR), (e.g., retinal vein or artery occlusion, CNV, retinal detachment, macular hole, vitreomacular traction, etc.); 5) Iris neovascularization; 6) Evidence of uncontrolled glaucoma( Intraocular pressure >25 with glaucoma medication) or anti-glaucoma surgery; 7) Server cataract influence judgment or need cataract surgery in 6 months; 8) Aphakia; Received other ocular treatment; 9) Intravitreal injection of corticosteroid in 3months 10) History of vitreous surgery 11) Focal laser treatment in 3 months 12) Received anti-VEGF treatment in 6 months 13)History of intraocular surgery in 3 months 14) History of macular surgery in 3 months Systemic diseases 15) Unsatisfactory blood glucose control 16) 3 months before screening, blood sugar control was not ideal (defined as turn oral antidiabetic drugs into insulin therapy, insulin pump treatment or daily insulin injection times doubled); 17) impaired renal function (Crea higher than the upper limit of the normal laboratory center 2 times) or liver dysfunction (ALT, AST higher than the upper limit of the normal laboratory center 2 times); 18) Poor blood pressure control (defined as systolic blood pressure = 150 mmHg or diastolic blood pressure = 95 mmHg after antihypertensive therapy); 19) is suffering from oral, intramuscular or intravenous administration of systemic infection; 20) Stroke, transient ischemic attack, myocardial infarction or acute congestive heart failure occurred within 6 months before the screening; 21) coagulation dysfunction (prothrombin time = normal upper limit of 3 seconds, activated partial thromboplastin time = normal upper limit of 10 seconds); 22)Drugs that are toxic to the lens, retina, or optic nerve may be required during use or during the study (Such as deferoxamine, chloroquine, hydroxychloroquine, tamoxifen, phenothiazine or ethambutol, etc.); 23) have a diagnosis of systemic immune diseases (such as ankylosing spondylitis, systemic lupus erythematosus, etc.) or any uncontrollable clinical problems (such as AIDS, malignancy, active hepatitis, severe mental, neurological, cardiovascular, Respiratory and other diseases, etc.); 24) allergic reactions or allergic history to sodium fluorescein, allergic history of protein products for treatment or diagnosis, allergies to two or more drugs and / or nonpharmacological factors, or is suffering from allergic diseases; other: 25) no use of effective contraception; Note: The following conditions are not excluded. I. Amenorrhea 12 months under natural circumstances, or natural amenorrhea for 6 months and serum follicle-stimulating hormone levels <40 mIU / ml; Ii. Bilateral ovariectomy with or without hysterectomy after 6 weeks; Iii. Use of one or more of the following acceptable contraceptive methods: Sterilization (male with bilateral vasectomy, resection) Hormone contraceptive (implantable, patch-type, oral) O IUD, double barrier method Iv. Reliable contraceptive measures used throughout Iv. Reliable contraceptive measures used throughout the whole study period and adherence to the 30 days of discontinuation of the study drug (unacceptable contraceptive methods: regular abstinence - cale
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of MA;area of intraretinal hemorrage;area of hard exudation; | — |
Countries
China
Contacts
Public ContactXu Xun
Shanghai General Hospital
Outcome results
None listed