Neovascular age-related macular degeneration
Conditions
Interventions
BAT5906:BAT5906 injection
Lucentis:Lucentis
Sponsors
Eye Hospital, Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
50 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.Understand and sign the informed consent and be willing to follow up according to the time specified in the trial; 2.Age 50-85 years old (including boundary value), male and female; 3.Study the subjects who were diagnosed with neovascular age-related macular degeneration and still had active lesions confirmed by imaging examination. Active lesions were defined as the presence of any of the following lesions in the macular area: 1, intraretinal fluid 2, Lipid exudation in the retina, 3, Subretinal fluid 4, Subretinal hemorrhage 5, Retinal pigment epithelium detachment 6, Choroidal neovascularization leakage; 4.The total area of the study eye lesions = 19 letters, equivalent to Snellen visual acuity >= 20/400, measured by ETDRS visual chart at screening and baseline in non-study eyes.
Exclusion criteria
Exclusion criteria: 1.The study eyes received any intravitreal anti-VEGF therapy such as bevacizumab abbercept ranibizumab conbercept etc within 3 months before randomization; 2.The study eyes had received the following treatments within 3 months before randomization: verteporfin photodynamic therapy (PDT), macular laser photocoagulation, transpillary thermotherapy (TTT), and other surgeries for AMD; 3.The study eyes had undergone the following ophthalmic surgeries: vitrectomy, anti-glaucoma surgery, and macular transposition. The study eyes had undergone internal eye surgery (including cataract surgery) within 3 months before randomization, or external eye surgery within 1 month before randomization; 4.The study eyes received intravitreal injection treatment (such as triamcinolone acetonide and dexamethasone) within 3 months before randomization, intravitreal injection of dexamethasone sustained release within 6 months, and injection of long-acting corticosteroids (such as triamcinolone acetonide, etc.) within, periocular or subconjunctival injection of any eye 3 months before randomization; 5.Study eyes with ocular diseases affecting central vision (such as diabetic retinopathy, retinal vein occlusion, uveitis, vascular striation, pathological myopia, retinal detachment, macular hole, macular epiretinal membrane, toxoplasmosis, optic nerve diseases); 6.Study eyes with foveal ground pattern atrophy, scar or fibrosis, dense subfoveal hard exudation, retinal pigment epithelium (RPE) tear involving the center of the macula (confirmed by the reading center during screening); 7.The study eyes had choroidal neovascularization not caused by nAMD, progressive retinopathy affecting corrected visual acuity, and any eye had vitreous hemorrhage or a history of vitreous hemorrhage, or a history of retinal detachment; 8.The equivalent spherical mirror of the study eye with refractive error showed more than -6.0 diopters. For patients with previous refractive surgery or cataract surgery, the preoperative refractive error of the study eye should not exceed -6.0 diopters; 9.The study eyes were lens free (excluding IOL eyes) or posterior lens capsule rupture (except YAG laser posterior capsuleotomy after IOL implantation more than 1 month before screening); 10.The study eye has obvious refractive interstitial opacity or pupil failure, including cataract and corneal opacity, which may interfere with visual acuity assessment, safety assessment or fundus photography; 11.The study eyes had pupil afferent defect (APD); 12.Study eyes had uncontrolled glaucoma at randomization, defined as intraocular pressure that remained higher than 25mmHg after medical treatment or as judged by the investigator; 13.Non-study eyes received photodynamic therapy (PDT) within 1 month before randomization; 14.History of idiopathic or autoimmune associated uveitis in any eye; 15.Pseudocyst stripping syndrome in any eye; 16.Active eye infection in any eye (e.g., blepharitis, infectious conjunctivitis, keratitis, scleritis, iridecocyclitis, endophthalmitis); 17.Systemic drugs that cause crystal or retinal toxicity, such as deferoxamine, chloroquine/hydroxychloroquine, phenothiazine and ethambutol or tamoxifen, are currently being used or may be required; 18.Allergic reaction or history to sodium fluorescein and indocyanine green, allergic history to protein products for therapeutic or diagnostic use, or known allergic reaction to any monoclonal antibody; 19.Patients who had surgery within 1 month befo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compared to baseline, the changes in BCVA at week 52 in the study eyes of two groups of subjects; | — |
Secondary
| Measure | Time frame |
|---|---|
| increase of>10,>15, or = 30 words in BCVA at the 24th and 52nd weeks of the study eye;The proportion of subjects with a decrease in BCVA of<10 or<15 words at the 24th and 52nd weeks;Changes in macular fovea thickness (CRT) at weeks 12, 24, 36, 48, and 52 of the study eye;Compared to baseline, the changes in BCVA at weeks 12, 24, 36, and 48 in the study eyes of two group; | — |
Countries
China
Contacts
Public ContactXiaoling Liu
Eye Hospital, Wenzhou Medical University
Outcome results
None listed