SCT520FF treatment for neovascular (wet) age-related macular degeneration

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

This study will test whether injections of SCT520FF are safe and help people aged 45–80 with neovascular (wet) age-related macular degeneration.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 82 (estimated)
• Ages: 45 Years to 80 Years
• Sex: All
• Sponsor: Sinocelltech Ltd. (Industry-sponsored)
• Locations: 1 site (Tianjing)
• Trial ID: NCT06672536 on ClinicalTrials.gov

What this trial studies

This multicenter, open-label Phase I/II study will give multiple doses of SCT520FF to adults with active macular neovascularization from nAMD to characterize safety, tolerability, pharmacokinetics and preliminary efficacy. Participants will receive scheduled intravitreal injections and be monitored with visual acuity testing, retinal imaging, and safety assessments during treatment and follow-up. The protocol includes comparison to standard aflibercept (EYLEA 2 mg) dosing or standard-of-care as specified, and enrolls patients with lesion area ≤12 optic disc areas and baseline BCVA between 73 and 19 ETDRS letters. Key exclusions include significant subfoveal scarring, other macular disease, active ocular infection or inflammation, and known allergy to study drug components.

Who should consider this trial

Good fit: Adults aged 45–80 with active macular neovascularization from nAMD, lesion area ≤12 optic disc areas, and baseline visual acuity between 73 and 19 ETDRS letters without major ocular comorbidities are the intended participants.

Not a fit: Patients with extensive subfoveal scarring, fibrosis or atrophy, dense subfoveal exudation, other macular diseases, active ocular inflammation or infection, or known allergy to the drug components are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, SCT520FF could provide a safe alternative or improved option to maintain or improve vision in people with wet AMD.

How similar studies have performed: Other anti-VEGF drugs such as aflibercept (EYLEA) are proven effective for nAMD, but SCT520FF is a novel formulation with limited published clinical data so far.

Eligibility criteria

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.

Where this trial is running

Tianjing

• Tianjin Medical University Eye Hospital — Tianjing, China (Recruiting)

Study contacts

• Study coordinator: Li Xiaorong

Conditions nAMD