NCT06672536RecruitingPhase 1/2
Multicenter, Phase I/II Study to Evaluate the Safety, Tolerability, PK and Efficacy of SCT520FF in Patients With nAMD
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
Source: ClinicalTrials.gov · Last updated 4 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Multicenter, open-label, multi-dose study to evaluate the safety and tolerability in patients with nAMD treated with SCT520FF.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 82 (estimated)
- First submitted
- 29 Oct 2024
- Start date
- 26 Nov 2024
- Primary completion date
- 23 Sept 2026
- Lead sponsor
- Sinocelltech Ltd.
- Diseases
- Macular degeneration
- NCT number
- NCT06672536
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 82
- From 26 Nov 2024 to the primary completion date, 23 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- The study eye has any eye diseases or medical history other than nAMD that may affect central vision and/or macular examine.
- 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.
Other
- 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.
- MNV caused by non-nAMD exists in the study eye .
- Abnormal liver and kidney function.
- Poorly-controlled blood pressure before randomization.
- Pregnant, lactating women who can not take contraceptive measures during the trial.
Who the study is looking for
- 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.
Age in the registry: 45 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tianjin Medical University Eye Hospital Coordinator of this site? Confirm its status | Tianjing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.