Multicenter, Phase I/II Study to Evaluate the Safety, Tolerability, PK and Efficacy of SCT520FF in Patients With nAMD

Korábbi kezelés

• 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.

Más betegség

• The study eye has any eye diseases or medical history other than nAMD that may affect central vision and/or macular examine.
• 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.

Egyéb

• 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.
• MNV caused by non-nAMD exists in the study eye .
• Abnormal liver and kidney function.
• Poorly-controlled blood pressure before randomization.
• Pregnant, lactating women who can not take contraceptive measures during the trial.

• 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.