Overview
Multicenter, open-label, multi-dose study to evaluate the safety and tolerability in patients with nAMD treated with SCT520FF.
Eligibility
Inclusion Criteria:
- Signed informed consent form.
- Age≥45 years, ≤80 years，male or femal.
- The study eye must meet the following criteria: Diagnosis of nAMD;Active MNV lesions secondary to nAMD; Total area of all types of lesions ≤12 optic disc areas; BCVA of the study eye 73~19 letters.
Exclusion Criteria:
- Macular-related retinal pigment epithelial tears in the study eye; scar, fibrosis, atrophy or dense subfoveal exudation involving the fovea in the study eye.
- Significant APD or opacity of the refractive medium and miosis in the study eye that affect visual acuity or fundus examination.
- Aphakia (except intraocular lens) or posterior capsular rupture of the lens in the study eye.
- The study eye has any eye diseases or medical history other than nAMD that may affect central vision and/or macular examine.
- MNV caused by non-nAMD exists in the study eye .
- Active inflammation or infection in either eye before randomization.
- Known allergy to any component of the study intervention or history of allergy to fluorescein or indocyanine green, any anesthetics or antimicrobial agents used during the course of the study.
- Abnormal liver and kidney function.
- Poorly-controlled blood pressure before randomization.
- History of a cardiovascular and cerebrovascular events, including myocardial infarction, unstable angina pectoris, cerebrovascular accidents (including TIA), other thromboembolic diseases (such as thromboembolic angiitis, etc) within 6 months before randomization.
- Evidence of significant uncontrolled concomitant diseases.
- Participated in any drug (other than vitamins and minerals) or device clinical trials within 3 months or the duration of 5 half-lives of the study drug (which is longer) before randomization and have used the test drug or received device treatment.
- Pregnant, lactating women who can not take contraceptive measures during the trial.