Diabetic macular edema
Conditions
Interventions
2.5mg/eye:Specification: 10mg / 0.2ml / piece
4mg/eye:Specification: 16mg / 0.2ml / branch
Duration of administration: once every 4 weeks, 3 times after continuous administration, the effectiveness was observed to the 48th week.
Sponsors
Beijing Union Medical College Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Only when all the following criteria are met can they be selected: 1. Patients who voluntarily sign the informed consent are willing and able to follow the outpatient visit and research related procedures within the time specified in the trial 2. The patients with type 1 or type 2 diabetes were 18-80 years old; 3. Drug treatment for diabetes control must be stable within the first three months of randomization and is expected to remain stable during the study period; 4. The patients with macular edema secondary to diabetes mellitus were found to be involved in the study macular Center (fovea) by OCT examination, which was confirmed by the film reading center during screening; 5. CRT >= 300 µ m was assessed by OCT and confirmed by the film reading center during screening; 6. The BCVA of study eye is 73-24 letters (using ETDRS table, including boundary value, equivalent to Snellen vision score of study eye is equal to 20 / 40-20 / 400); 7. BCVA >= 34 letters in contralateral eyes (using ETDRS table, equivalent to Snellen vision >= 20 / 200). Note: if both eyes meet the inclusion criteria, the eyes with poor baseline vision shall be selected as the study eyes; 8. At screening and baseline, the researchers determined that the contralateral eye was not expected to require any anti VEGF treatment within 3 months (PK group only).
Exclusion criteria
Exclusion criteria: Patients will not be admitted to this study if they meet any of the following conditions:: Eye exclusion criteria: 1. Research on the presence of structural damage to the center of the macula, which may result in the best corrected vision after macular edema subsided Obvious damage), macular anterior membrane involving fovea or mechanized rigid exudate under the fovea (confirmed by reading center); 2. The research eye has iris lesions and neovascular glaucoma; 3. Those who have no eye lens (except intraocular lens); 4. The study eye has active hyperplastic diabetic retinopathy (PDR); 5. The research eye has anyone other than diabetic macular edema that may confuse macular assessment or vision testing (retinal vascular occlusion, retinal detachment, vitreous macular traction, macular hole, preretinal fibrosis involving the macula, choroidal neovascularization, age Related macular degeneration, etc.); 6. The research eye is accompanied by poorly controlled glaucoma, which is defined as the intraocular pressure still >= 21mmHg after treatment with anti-glaucoma drugs, or according to the judgment of the investigator; 7. The research eye has undergone or may have undergone anti-glaucoma surgery during the study period (including trabeculectomy, sclerectomy and non-penetrating trabecular surgery, etc.); 8. The research eye has undergone vitreoretinal surgery or scleral buckling; 9. At the time of screening and baseline, the study eye had received laser photocoagulation (total retina or macular laser photocoagulation) within 90 days (including 90 days) or during the study period; 10. At the time of screening and baseline, the study eye had any intraocular or perocular surgery within 90 days (including 90 days) (except for yttrium-aluminum-garnet (YAG) lens capsule incision and eyelid surgery for more than 30 days); 11. A history of uveitis in any eye; 12. Any eye has active ocular inflammation or infection (bacterial, viral, parasitic or fungal infection); 13. At the time of screening and baseline, any eye received intra-ocular anti-VEGF treatment within the first 90 days (including 90 days), such as ranibizumab, bevacizumab, abecept, and compacept. 14. At the time of screening and baseline, any eye has received intraocular, periocular, and subconjunctival corticosteroid treatment within the first 90 days (including 90 days). Exclusion criteria for abnormal conditions in laboratory inspection: 15. Abnormal liver and kidney function (this test stipulates that ALT and AST should not be higher than 2.5 times the upper limit of the normal value of the laboratory in the center; Crea and BUN should not be higher than 2 times the upper limit of the normal value in the laboratory of the center); 16. Abnormal blood coagulation function (prothrombin time >= upper limit of normal value 3 seconds, activated partial thromboplastin time >= upper limit of normal value 10 seconds); 17. Any one of the infected patients: active hepatitis B (if HBsAg (+), HBV DNA must be greater than 500 IU / mL or the hospital maximum limit), hepatitis C, AIDS or syphilis (syphilis RPR test positive). Other exclusion criteria: 18. Myocardial infarction or stroke occurred within 6 months before the first dose; 19. Poorly controlled diabetes [defined as glycated hemoglobin (HbA1c)> 9%)]; 20. With uncontrollable hypertension (defined as blood pressure> 160/100 mmHg after treatment with antihypertensive drugs); 21. Patients with large doses of oral or i
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FAS;PPS;SAS;PKAS;Analysis of VEGF concentration in peripheral blood;Immunogenicity analysis set; | — |
Countries
China
Contacts
Public ContactYouxin Chen
Beijing Union Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed