Wet age-related macular degeneration
Conditions
Interventions
2.5mg/eye :Specification: 10mg / 0.2ml / piece
4mg/eye :48 zhou. 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
50 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. The patient or his / her legal representative authorized by the patient signs the informed consent, fully understands the test content, process and possible adverse reactions, and is willing to follow up according to the time specified in the test; 2. Patients aged 50-85 (including boundary value), male and female unlimited; 3. The patients who were diagnosed as active choroidal neovascularization (CNV) secondary to wet age-related macular degeneration were confirmed by the film reading center during screening; 4. Patients with total area of eye lesions = 34 letters in the contralateral eye (using ETDRS visual chart, equivalent to Snellen visual acuity >= 20 / 200). In the PK group, the researchers need to judge that the contralateral eye is not expected to need any anti VEGF treatment within 3 months.
Exclusion criteria
Exclusion criteria: Patients will not be admitted to this study if they meet any of the following conditions: Those with the following eye conditions: 1. There were map like atrophy, scar or fibrosis, macular anterior membrane, dense hard exudation, RPE tear, etc. involving fovea in the eyes (confirmed by the reading center at the time of screening); 2. To study the area of retina hemorrhage >= 4 discs (confirmed by the reading center during screening); 3. The study eye had significant interference in visual acuity test, anterior segment and fundus evaluation, and the refractive media was turbid or pupil could not be dilated; 4. There are other fundus diseases in the study eyes (such as diabetic retinopathy, retinal vein occlusion, vascular striation, pathological myopia, retinal detachment, macular hole, toxoplasmosis, optic nerve diseases, etc.); 5. Study eyes with pupillary afferent defect (APD); 6. There was uncontrolled glaucoma in the study eyes at screening and baseline, defined as intraocular pressure still higher than 21mmhg after drug treatment, or according to the judgment of the researchers; 7. Before screening, the study eyes had been treated with dexamethasone or iluvien; 8. Within 3 months before screening, the research eyes had received the following treatments: PDT, laser photocoagulation of the whole retina, laser photocoagulation of the macular region, and transpupillary thermotherapy for AMD; 9. The research eyes have received the following ophthalmic operations: vitrectomy, macular transposition, anti glaucoma surgery; 10. External eye surgery or cataract surgery was performed or may be performed during the study within 3 months before the study eye screening; 11. Aphakia (excluding intraocular lens) or posterior capsule rupture (excluding YAG laser posterior capsulotomy after intraocular lens implantation more than 1 month from screening) were studied; 12. The contralateral eyes received PDT within 1 month before screening; 13. Patients with uveitis in any eye; 14. Patients who had vitreous hemorrhage in any eye during the screening period or who had vitreous hemorrhage history within 4 weeks before baseline; 15. Patients with pseudocapsular exfoliation syndrome in any eye; 16. Patients with active ocular infection in any eye (such as blepharitis, infective conjunctivitis, keratitis, scleritis, iridocyclitis, endophthalmitis); 17. In the three months before screening, patients who had received intravitreal injection of anti VEGF drugs in any eye (such as arbacip, conbercept, rezumab, bevacizumab, etc.); 18. To screen the patients (such as triamcinolone acetonide, dexamethasone, etc.) who injected corticosteroids into the eyes, periocular or subconjunctival at random within the first 3 months; Any of the following general conditions: 19. Patients who are currently using or may need to use systemic drugs that may cause crystal toxicity or retinal toxicity, such as desensitization, chloroquine / hydroxychloroquine, phenothiazine, ethambutol or tamoxifen, etc; 20. Patients who have allergic reaction or history to fluorescein sodium and indocyanine green, have allergic history to protein products for treatment or diagnosis, or are known to have allergic reaction to any kind of monoclonal antibody; 21. Patients who have received systemic anti VEGF treatment before; 22. In the first 6 months of screening, patients with large doses of oral or injection corticosteroids and other hormone drugs (> 10 mg prednisolone or th
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