Ireland
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Recruiting Phase 1/2

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

NCT06672536 · tracked via the Priya Life Science China tracker
Phase
Phase 1/2
Started
2024-11-26
Last updated
2025-09-04

Condition(s) studied

nAMD

Investigational drug(s) / intervention(s)

SCT520FFSCT520FFSCT520FFEYLEA 2 MG →

SCT520FF: SCT520FF dose level 1,IVI

SCT520FF: SCT520FF dose level 2,IVI

SCT520FF: SCT520FF dose level 3,IVI

EYLEA 2 MG: EYLEA 2 MG,IVI,injection once every 4 weeks,during the study period

Study summary

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

Eligibility

Sex
ALL
Min age
45 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Treatment emergent adverse events(TEAE) — From Day 0 up to 196days
    Incidence of treatment emergent adverse events
  • Treatment-related treatment emergent adverse events(TRAE) — From Day 0 up to 196days
    Incidence of treatment-related treatment emergent adverse events
  • Serious adverse event(SAE) — From Day 0 up to 196days
    Incidence of serious adverse event
  • Adverse event of special interest(AESI) — From Day 0 up to 196days
    Incidence of adverse event of special interest
  • Dose limited toxicity(DLT) — From Day 0 up to 196days
    Incidence of dose-limiting toxicities

Trial sites (1)

FacilityCityRegionStatus
Tianjin Medical University Eye Hospital Tianjing China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06672536 on ClinicalTrials.gov ↗ ← All trials in China