Wet age-related macular degeneration
Conditions
Interventions
Group 1:0.75mg, intracireal injection
Group 2:1.25mg, intracireal injection
Group 3:2.5mg, intracireal injection
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Sign the informed consent form and be willing to follow up according to the time specified in the study; 2) Male or female aged 50-80 years; 3) The study eye must meet all the following inclusion criteria: To be diagnosed as wet-AMD patients; Primary or recurrent subfoveal CNV resulting from AMD located under macular central fovea and near central fovea; Total lesion size of =19 letters in the non-study eye (20/400 letters Snellen equivalent).
Exclusion criteria
Exclusion criteria: Have any of the following eye conditions: 1) Ocular or periocular infection in either eye (such as blepharitis, infective conjunctivitis, keratitis, scleritis, iridocyclitis, endophthalmitis, etc.); 2) Active choroidal neovascularization (CNV) lesions were found in the the non-study eye; 3) Vitreous hemorrhage within 2 months prior to screening Visit in either eye; 4) There is scar,fibrosis or atrophy in the fovea of the study eye; 5) Drug therapy for CNV (such as aflibercept[Eylea, ranibizumab[Lucentis, bevacizumab[Avastin]or conbercept, acnike acetate, triamcinolone; acetonide,OZURDEX,steroids,etc.) in either eye within 3 months prior to screening visit; 6) The study eye has received the following eye surgeries for AMD within 3 months prior to screening visit,such as PDT, macular translocation, glaucoma Filtration, fovea photocoagulation, vitrectomy and transpupillary hyperthermia, among others Submacular surgery or other surgery for AMD; 7) CNV in the study eye was secondary to other diseases besides AMD, such as pathological myopia,trauma, etc.; 8) Uncontrolled glaucoma in the study eyes at screening and baseline(intraocular pressure>25mmHg after antiglaucoma treatment), or the cup/optic disc ratio>0.8 in the study eye caused by severe glaucoma, or The stduy eye underwent glaucoma filtering surgery; 9) Subretinal hemorrhage area >= 50% of the total lesion area in the study eye, or the hemorrhage area under the fovea >= 1 optic disc area; 10) The study eye has a history of rhegmatogenous retinal detachment or macular retinal detachment (stage 3 or 4), with retinal detachment, retinal pigment epithelial tear or retinal traction in the macular area and epiretinal membrane in the macular area; 11) Aphakia(exclusive of intraocular lens) or rupture of posterior capsule(except for the YAG laser retrovesiculotomy after the artificial crystal) in the study eye; 12) Subject who are currently using or may need to use systemic drugs that may cause crystal toxicity ,retinal or optic nerve toxicity, such as tamoxifen, deferoxamine, chloroquine, phenothiazine, ethambutol, etc.; 13) Subject who are allergic to the therapeutic drugs and their auxiliary materials or diagnostic drugs (fluorescein sodium, indocyanine green, etc.), have allergic history to protein products for treatment or diagnosis, or are currently suffering from allergic diseases; 14) History of surgery within 1 month prior to screening, and/or having an unhealed wound, ulcer, fracture and so on currently; 15) The infectious disease requiring oral, intramuscular or intravenous administration; 16) Patients with active cardiovascular and cerebrovascular diseases within 6 months prior to screening visit; A) History of myocardial infarction, severe/unstable angina pectoris; B) History of cardiovascular surgery (heart, stenting, angioplasty); C) Severe arrhythmia; D) A history of stroke or transient ischemic attack; E) History of subarachnoid hemorrhage; F) Epilepsy patients without effective control; G) Patients with major vascular diseases (aortic aneurysm, aortic dissecting aneurysm, internal carotid artery stenosis); 17) Patients with active diffuse intravascular coagulation and obvious bleeding tendency in the first 3 months before Screening; 18) Patients with systemic immune diseases; 19) Hypertensive patients with poor blood pressure control (blood pressure >= 150/90mmHg) after antihypertensive drug treatment; 20) Diabetic patients with poor blood glucos
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| security;BCVA; | — |
Secondary
| Measure | Time frame |
|---|---|
| Central Retinal Thickness, CRT;Area of choroidal neovascularization leakage;pharmacokinetics;pharmacodynamics;ADA; | — |
Countries
China
Contacts
Public ContactYouxin Chen
Peking Union Medical College Hospital
Outcome results
None listed