Multicenter, Phase I/II Study to Evaluate the Safety, Tolerability, PK and Efficacy of SCT520FF in Patients With nAMD
NCT ID: NCT06672536
Last Updated: 2025-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
82 participants
INTERVENTIONAL
2024-11-26
2027-01-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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SCT520FF dose level 1 treatment
SCT520FF dose level 1(0.625mg),IVI,injection once every 4 weeks,three times continuously
SCT520FF
SCT520FF dose level 1，IVI
SCT520FF dose level 2 treatment
SCT520FF dose level 2(1.25mg),IVI,injection once every 4 weeks,three times continuously
SCT520FF
SCT520FF dose level 2，IVI
SCT520FF dose level 3 treatment
SCT520FF dose level 3(2.5mg),IVI,injection once every 4 weeks,three times continuously
SCT520FF
SCT520FF dose level 3，IVI
eylea 2 mg
eylea 2 mg,IVI,injection once every 4 weeks,during the study period
EYLEA 2 MG
EYLEA 2 MG,IVI,injection once every 4 weeks,during the study period
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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.
45 Years
80 Years
ALL
No
Sponsors
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Tianjin Medical University Eye Hospital
OTHER
Sinocelltech Ltd.
INDUSTRY
Responsible Party
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Locations
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Tianjin Medical University Eye Hospital
Tianjing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SCT520FF-A201
Identifier Type: -
Identifier Source: org_study_id
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