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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Tianjin Medical University Eye Hospital
  Tianjing, China Recruiting

Study contacts

• Study coordinator: Li Xiaorong
• Email: 35479080@qq.com
• Phone: +86-18626789043

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• GNR-139 vs Eylea in nAMD: a head-to-head comparison

  This trial tests whether the biosimilar GNR-139 can match the effectiveness of Eylea in adults with neovascular age-related macular degeneration who have not yet received treatment.

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• ABP 938 8 mg vs EYLEA® HD (aflibercept) in neovascular AMD

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• IVB103 injection for wet age-related macular degeneration in adults

  This trial tests whether IVB103 injected into the eye is safe and helps vision in adults with active wet AMD who have had prior anti-VEGF treatment.

  Recruiting Phase 1 InnoVec Biotherapeutics Inc. · Chengdu, Sichuan · NCT06737354

• Aflibercept 8 mg in real-world neovascular AMD

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• Long-term safety test of the Axitinib implant for people with neovascular AMD who finished prior OTX-TKI studies

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  Recruiting at 8 sites Phase 3 Ocular Therapeutix, Inc. · Bakersfield, California and 7 other locations · NCT07516132

• Ixo-vec gene therapy versus aflibercept for wet age-related macular degeneration (AQUARIUS)

  This study tests whether a single injection of Ixo-vec gene therapy can maintain or improve vision as well as regular aflibercept injections in adults aged 50 and older with active neovascular (wet) AMD.

  Recruiting at 79 sites Phase 3 Adverum Biotechnologies, Inc. · Mesa, Arizona and 78 other locations · NCT07482176

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.