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

Sinocelltech

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: nAMD

Treatments: Drug: SCT520FF; Drug: EYLEA 2 MG

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06672536

SCT520FF-A201

Details and patient eligibility

About

Multicenter, open-label, multi-dose study to evaluate the safety and tolerability in patients with nAMD treated with SCT520FF.

Enrollment: 82 estimated patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed informed consent form.
2. Age≥45 years, ≤80 years，male or femal.
3. 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

1. Macular-related retinal pigment epithelial tears in the study eye; scar, fibrosis, atrophy or dense subfoveal exudation involving the fovea in the study eye.
2. Significant APD or opacity of the refractive medium and miosis in the study eye that affect visual acuity or fundus examination.
3. Aphakia (except intraocular lens) or posterior capsular rupture of the lens in the study eye.
4. The study eye has any eye diseases or medical history other than nAMD that may affect central vision and/or macular examine.
5. MNV caused by non-nAMD exists in the study eye .
6. Active inflammation or infection in either eye before randomization.
7. 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.
8. Abnormal liver and kidney function.
9. Poorly-controlled blood pressure before randomization.
10. 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.
11. Evidence of significant uncontrolled concomitant diseases.
12. 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.
13. Pregnant, lactating women who can not take contraceptive measures during the trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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82 participants in 4 patient groups

SCT520FF dose level 1 treatment

Experimental group

Description:

SCT520FF dose level 1(0.625mg),IVI,injection once every 4 weeks,three times continuously

Treatment:

Drug: SCT520FF

Drug: SCT520FF

Drug: SCT520FF

SCT520FF dose level 2 treatment

Experimental group

Description:

SCT520FF dose level 2(1.25mg),IVI,injection once every 4 weeks,three times continuously

Treatment:

Drug: SCT520FF

Drug: SCT520FF

Drug: SCT520FF

SCT520FF dose level 3 treatment

Experimental group

Description:

SCT520FF dose level 3(2.5mg),IVI,injection once every 4 weeks,three times continuously

Treatment:

Drug: SCT520FF

Drug: SCT520FF

Drug: SCT520FF

eylea 2 mg

Active Comparator group

Description:

eylea 2 mg,IVI,injection once every 4 weeks,during the study period

Treatment:

Drug: EYLEA 2 MG