Neovascular Age-related Macular Degeneration
Conditions
Interventions
low dose group:injection at low dose
medium dose group:injection at medium dose
high dose group:injection at high dose
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
50 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Fully understand the study and are willing and able to provide written and signed informed consent; Willing to follow and able to complete all test procedures; 2. Aged 50-85 years, no gender limit; 3. The target eye was diagnosed with subfoveal active MNV lesions secondary to nAMD (defined as evidence of subretinal effusion, hyperrefractive matter or leakage in or below the retina) and required anti-VEGF therapy; 4. Have received at least 3 previous treatments with vitreous anti-VEGF proteins and have responded; 5. The optimal corrected visual acuity (BCVA) in the target eye of the first subject in each group was between =20/400 (=19 ETDRS), followed by BCVA of the remaining patients in the group between =20/400 (=19 ETDRS); 6. Response to anti-VEGF protein drugs during screening (OCT assessment at 1 week after injection); 7. The target eye must be an intraocular lens (after cataract surgery); 8. If both eyes meet the inclusion criteria, select the eye with poor vision as the target eye.
Exclusion criteria
Exclusion criteria: 1. Target eye: (1) Non-NAMD-induced MNV or macular edema in the target eye; (2) Any condition in the target eye that impedes vision improvement, such as scarring, fibrosis, geoglyphic atrophy, or retinal epithelial tears involving the fovea; (3) The target eye has any eye disease or history other than nAMD that may affect central vision and/or macular detection (diabetic retinopathy, retinal vein occlusion, retinal detachment, macular hole, macular premembrane, retinal pigment epithelial tear involving macular, vitreous macular traction syndrome, optic nerve disease, etc.); (4) The target eye has poorly controlled glaucoma (defined as intraocular pressure >= 25 mmHg after anti-glaucoma treatment) and/or has undergone glaucoma filtering surgery (e.g. trabeculectomy, scleral biting, non-penetrating trabecular surgery, etc.); (5) In the 6 months prior to screening, the target eye had received intravitreal therapy in addition to anti-VEGF therapy, such as intravitreal steroid injections or experimental drugs; (6) There are implants in the target eye during screening (excluding intraocular lens); (7) The target eye had undergone internal eye surgery, including cataract surgery, within 3 months prior to screening. 2. Any eye: (1) History of uveitis; (2) Active inflammation or infection in, outside or around the eye; (3) One-eyed patients, defined as non-target eyes with BCVA160 mmHg or diastolic blood pressure >100 mmHg after receiving antihypertensive medication); (4) Abnormal liver and kidney function: 1) Liver function: alanine aminotransferase and/or aspartate aminotransferase >2.5x upper limit of normal (ULN); Total bilirubin >1.5xULN; 2) Renal function: serum creatinine > 1.5xULN; (5) Abnormal coagulation function: 1) Prothrombin time >=1.5xULN, activated partial thrombin time >=1.5xULN; 2) Taking antiplatelet drugs or anticoagulants within 1 month prior to screening (patients taking aspirin daily dose =1:1000; (7) Surgical history within 1 month before screening, or existing unhealed wounds, ulcers, fractures, etc.; (8) The presence of one of the following: an active infection that the investigator believes may affect the patient's participation in the study or affect the study results that requires systematic treatment; Hepatitis B surface antigen positive, hepatitis B virus deoxyribonucleic acid (HBV DNA) copy number > ULN; Hepatitis C virus (HCV) antibody positive, hcV-RNA copy number >ULN; Antibody positive for treponema pallidum; Human immunodeficiency virus (HIV) antibody positive; (9) Systemic immune system diseases; (10) History of malignant tumor; (11) Pregnant or lactating patients; Patients who are unable to use contraception during the trial and within 3 months after the end of the study per
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Change in best corrected visual acuity;Change in central retinal thickness;Rescue injections;Change in area of MNV and leakage; | — |
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Countries
China
Contacts
Public ContactLu Fang
West China Hospital of Sichuan University
Outcome results
None listed