Wet age-related macular degeneration
Conditions
Interventions
MW02 Q4w:injection of MW02 every 4 week
MW02 Q8w:The first 3 injections, Q4w, followed by Q8w, were injected with MW02
lucentis:injection of lucentis every 4 week
Sponsors
Mabwell (Shanghai) Bioscience Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Fully understand this research and sign ICF; Willing to follow and be able to complete all study procedures; 2. Aged >= 50 years and = 50% of the total lesion area.
Exclusion criteria
Exclusion criteria: Study eye: 1. There is subretinal or intraretinal hemorrhage in the study eye, and the bleeding area is >= 50% of the total lesion area, or it is located in the fovea and the area is >= 1 optic disc area; 2. The study eye has scar, fibrosis, geographic atrophy and dense hard exudation under the fovea. 3. CNV caused by non-nAMD exists in the study eye (such as trauma, pathological myopia, multifocal choroiditis, ocular histoplasmosis, vascular stripes, etc.); 4. The study eye has any eye diseases or medical history other than nAMD that may affect central vision and/or macular examine (diabetic retinopathy, retinal vein occlusion, retinal detachment, macular hole, macular epiretinal membrane, retinal pigment epithelium tear involving macular, vitreous macular traction syndrome, optic nerve disease, etc.); 5. Intravitreous hemorrhage occurred in the study eye within 30 days before the first administration. 6. The study eye has received the following intraocular surgery within 90 days, or has previously received various macular laser treatments (such as macular transposition, transpupillary thermotherapy, macular photocoagulation, vitrectomy, optic nerve incision, optic nerve sheath incision, etc.) (except those who have received Vitepofin-photodynamic therapy, cataract surgery and YAG posterior capsulotomy more than 3 months before screening) or have performed external eye surgery within 30 days; 7. The study eye has used corticosteroids in the eye or in the whole body within 3 months or injected corticosteroids around the globe within 30 days before the first administration; 8. The study eye has poorly controlled glaucoma (defined as intraocular pressure >= 25 mmHg after anti-glaucoma treatment), and/or has received glaucoma filtering surgery (such as trabeculectomy, scleral bite, non-penetrating trabecular surgery, etc.); 9. The study eye has high myopia with diopter >= 8D; 10. The study eye has refractive interstitial turbidity and/or myosis that affect fundus or OCT examination; 11. Aphakia (except intraocular lens) or rupture of posterior capsule of lens (except YAG laser posterior capsulotomy after intraocular lens implantation more than 30 days before the first administration); 12. Scleromalacia exists in the study eye. Any eye: 1. 6 months before the first administration, any eye had received IVT anti-angiogenesis drug treatment [such as Aflibercept, Lucentis, Bevacizumab and Conbercept, etc.]; 2. Inject of corticosteroids (such as triamcinolone acetonide) into any eye 6 months before the first administration or 30 days Peribulbar. 3. There is a history of uveitis; 4. There is active inflammation or infection in the eye, intraocularextraocular or periocular; 5. One-eyed patients were defined as the fellow eyes with BCVA 2.5 x ULN or total bilirubin > 1.5 x ULN; B) renal function: serum creatinine > 1.5 x ULN; 4. Abnormal coagulation function: A) Prothrombin time >= 1.5 x ULN and partial thromboplastin activation time >= 1.5 x ULN; B) Take antiplatelet drugs or anticoagulants w
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BCVA; | — |
Countries
China
Contacts
Public ContactMing Zhang
West China Hospital of Sichuan University
Outcome results
None listed