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NCT Number: NCT06672536

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

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

Recruiting

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Key information

Conditions

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Tianjin Medical University Eye Hospital

Tianjing, China

Location status: Recruiting

Location contact

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SCT520FF

Drug

SCT520FF dose level 1,IVI

EYLEA 2 MG

Drug

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

Primary outcomes

  1. Treatment emergent adverse events(TEAE)

    Time frame: From Day 0 up to 196days

    Incidence of treatment emergent adverse events

  2. Treatment-related treatment emergent adverse events(TRAE)

    Time frame: From Day 0 up to 196days

    Incidence of treatment-related treatment emergent adverse events

  3. Serious adverse event(SAE)

    Time frame: From Day 0 up to 196days

    Incidence of serious adverse event

  4. Adverse event of special interest(AESI)

    Time frame: From Day 0 up to 196days

    Incidence of adverse event of special interest

  5. Dose limited toxicity(DLT)

    Time frame: From Day 0 up to 196days

    Incidence of dose-limiting toxicities

Secondary outcomes

  1. Best corrected visual acuity(BCVA)

    Time frame: Day 0 up to 196 days

    Mean change from baseline in BCVA

  2. central retina thickness(CRT)

    Time frame: Day 0 up to 196days

    Mean change from baseline in CRT

  3. PK profile

    Time frame: Day 0 up to 196days

    Change of SCT520FF drug concentration in the blood with time

  4. Cmax

    Time frame: Day 0 up to 196days

    The maximum blood concentration after SCT520FF drug enters the bloodstream

  5. Tmax

    Time frame: Day 0 up to 196days

    Time to the Maximum Concentration of SCT520FF

  6. PD profile

    Time frame: Day 0 up to 196 days

    Detection of free VEGF concentration

  7. Immunogenicity

    Time frame: Day 0 up to 196days

    Positive rate of ADA and NAb

Study contacts

Contact information is provided by the study sponsor or research team.

Li Xiaorong

CONTACT

[email protected]

+86-18626789043

Sponsors and collaborators

Lead sponsor

Sinocelltech Ltd.

Industry

Collaborators

  • Tianjin Medical University Eye Hospital

Registry information

Official study title

A Multicenter, Dose-escalation and Dose-expansion, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy Characteristics of SCT520FF in Patients With Neovascular Age-related Macular Degeneration

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Nov 4, 2024
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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