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

August 27, 2025 updated by: Sinocelltech Ltd.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

82

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Tianjing, China
        • Recruiting
        • Tianjin Medical University Eye Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SCT520FF dose level 1 treatment
SCT520FF dose level 1(0.625mg),IVI,injection once every 4 weeks,three times continuously
Drug: SCT520FF
SCT520FF dose level 1，IVI
Drug: SCT520FF
SCT520FF dose level 2，IVI
Drug: SCT520FF
SCT520FF dose level 3，IVI
Experimental: SCT520FF dose level 2 treatment
SCT520FF dose level 2(1.25mg),IVI,injection once every 4 weeks,three times continuously
Drug: SCT520FF
SCT520FF dose level 1，IVI
Drug: SCT520FF
SCT520FF dose level 2，IVI
Drug: SCT520FF
SCT520FF dose level 3，IVI
Experimental: SCT520FF dose level 3 treatment
SCT520FF dose level 3(2.5mg),IVI,injection once every 4 weeks,three times continuously
Drug: SCT520FF
SCT520FF dose level 1，IVI
Drug: SCT520FF
SCT520FF dose level 2，IVI
Drug: SCT520FF
SCT520FF dose level 3，IVI
Active Comparator: eylea 2 mg
eylea 2 mg,IVI,injection once every 4 weeks,during the study period
Drug: EYLEA 2 MG
EYLEA 2 MG,IVI,injection once every 4 weeks,during the study period

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best corrected visual acuity(BCVA)
Time Frame: Day 0 up to 196 days
Mean change from baseline in BCVA
Day 0 up to 196 days
central retina thickness(CRT)
Time Frame: Day 0 up to 196days
Mean change from baseline in CRT
Day 0 up to 196days
PK profile
Time Frame: Day 0 up to 196days
Change of SCT520FF drug concentration in the blood with time
Day 0 up to 196days
Cmax
Time Frame: Day 0 up to 196days
The maximum blood concentration after SCT520FF drug enters the bloodstream
Day 0 up to 196days
Tmax
Time Frame: Day 0 up to 196days
Time to the Maximum Concentration of SCT520FF
Day 0 up to 196days
PD profile
Time Frame: Day 0 up to 196 days
Detection of free VEGF concentration
Day 0 up to 196 days
Immunogenicity
Time Frame: Day 0 up to 196days
Positive rate of ADA and NAb
Day 0 up to 196days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sinocelltech Ltd.

Collaborators

Tianjin Medical University Eye Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2024

Primary Completion (Estimated)

September 23, 2026

Study Completion (Estimated)

January 11, 2027

Study Registration Dates

First Submitted

October 29, 2024

First Submitted That Met QC Criteria

November 1, 2024

First Posted (Actual)

November 4, 2024

Study Record Updates

Last Update Posted (Estimated)

September 4, 2025

Last Update Submitted That Met QC Criteria

August 27, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCT520FF-A201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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