Neovascular age-related macular degeneration
Conditions
Interventions
3+pro re nata Regimen:Intravitreal injection of Conbercept Ophthalmic Injection
3+Treat-and-Extend Regimen:Intravitreal injection of Conbercept Ophthalmic Injection
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1) Sign informed consent and be willing to follow up according to the time specified in the trial; 2) The study eye must meet the following criteria: Primary or recurrent subfoveal and parafoveal active choroidal neovascularization (CNV) lesions secondary to AMD; Best corrected visual acuity (BCVA) of the study eye is 19 to 73 letters (equivalent to Snellen visual acuity of 20/40 to 20/400); There is no refractive media opacity or miosis that affected the fundus examination;
Exclusion criteria
Exclusion criteria: 1) Study eye received intraocular treatment for CNV (e.g., conbercept, ranibizumab, aflibercept, bevacizumab, triamcinolone acetonide, steroids, etc.) within 3 months before screening; 2) The scar or fibrosis area is either 50% or more of the total lesion area, or the study eye has scar, fibrosis or atrophy under the fovea; 3) An active ocular infection in the study eye or the fellow eye (e.g., blepharitis, infectious conjunctivitis, keratitis, scleritis, endophthalmitis); 4) Patients with active PCV in the study eye by ICGA examination: The ICGA diagnostic criteria for "active" PCV are as follows: polypoid lesions with typical nodular hyperfluorescence (stereoscopic) and one of the following angiographic features: (1) nodular lesions surround by low fluorescence halos; ? The nodular lesions are nourished by abnormal vascular beds; ? Dynamic ICGA shows nodule pulsation. 5) The CNV in the study eye is secondary to other diseases other than AMD (such as pathological myopia) ; or existing or previous disease which is not the neovascular AMD in the study eye, has affected the detection of the macula or the central vision (such as diabetic retinopathy, central vein occlusion, etc.) according to the judgement of investigators; 6) Previous or current uncontrolled glaucoma (defined as an intraocular pressure > 25 mmHg despite anti-glaucoma treatment), severe glaucoma with a fovea-to-disc ratio > 0.8 in the study eye, or previous glaucoma filtering surgery in the study eye; 7) Patients with a history of allergic reaction or allergy to sodium fluorescein, a history of allergy to therapeutic or diagnostic protein products, and allergy to = 2 drugs and/or non-drug factors, or current allergic diseases; 8) Existing infectious diseases requiring oral, intramuscular or intravenous drug treatment; 9) Patients with active disseminated intravascular coagulation or significant bleeding tendency within 3 months before screening; 10) Patients with systemic immune diseases; 11) Any uncontrollable clinical problems (such as severe psychiatric, neurological, cardiovascular, respiratory and other system diseases and malignant tumors); 12) Patients who do not use effective contraception; 13) Pregnant or lactating women (pregnancy is defined as a positive urine pregnancy test in this study); 14) Participated in clinical trials of any other drug (excluding vitamins and minerals) other than conbercept within 3 months before screening (or 7 half-lives > 3 months if the investigational drug has a long half-life); 15) Patients who are deemed by the investigator to need exclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BCVA; | — |
Secondary
| Measure | Time frame |
|---|---|
| CRT;total macular volume;leakage area; | — |
Countries
China
Contacts
Public ContactMingwei Zhao
Peking University People's Hospital
Outcome results
None listed