Comparing SCT510A and Ranibizumab for treating wet age-related macular degeneration
Official title: A Phase III, Multicenter, Randomized, Double-Masked, Parallel Controlled, Non Inferior Study to Compare the Efficacy and Safety of SCT510A Administered by Intravitreal Injection With Ranibizumab in Subjects With Wet Age-related Macular Degeneration (wAMD)
Run by Sinocelltech Ltd. · NCT05480293 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing a new treatment called SCT510A to see if it works better than the standard drug Ranibizumab for people with wet age-related macular degeneration.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 45 Years and up |
| Sex | All |
| Enrollment | 446 (estimated) |
| Sponsor | Sinocelltech Ltd. Industry-sponsored |
| Drugs / interventions | ranibizumab, bevacizumab |
| Locations | 1 site (Beijing) |
| Trial ID | NCT05480293 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 45 and older with a diagnosis of active wet age-related macular degeneration who have not received anti-VEGF treatment in the past three months.
✕Probably not a fit
Patients with significant retinal damage or those who have received recent anti-VEGF treatments may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the efficacy and safety of SCT510A administered through intravitreal injection compared to Ranibizumab in patients suffering from wet age-related macular degeneration (wAMD). Participants will be assessed based on specific inclusion criteria, including age and the presence of active choroidal neovascularization lesions. The study will involve monitoring visual acuity and lesion area to determine the effectiveness of the treatments over time. The trial is designed to provide insights into a potentially new treatment option for wAMD.
Why it matters
Potential benefit: If successful, this study could offer a new effective treatment option for patients with wet age-related macular degeneration.
How similar studies have gone: Other studies have shown success with similar anti-VEGF treatments, but the specific efficacy of SCT510A compared to Ranibizumab is being evaluated for the first time.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Signed informed consent form; 2. Age≥45 years,male or femal; 3. The study eye must meet the following criteria: Diagnosis of wAMD; Primary or recurrent active subfoveal or parafoveal choroidal neovascularization (CNV) lesions secondary to wAMD; The total lesion area ≤ 30mm2; The BCVA letters between 19 and 73, inclusive, in the study eye, using Early Treatment Diabetic Retinopathy Study (ETDRS) charts; 4. The study eye has not received any anti-VEGF treatment within 3 months before randomization, such as ranibizumab, bevacizumab, conbercept, etc; 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 afferent pupillary defect (APD) in the study eye; 3. Aphakia (except intraocular lens) or posterior capsular rupture of the lens (except yttrium aluminium-garnet (YAG) laser posterior capsulotomy after intraocular lens implantation ≥1 month before randomization) 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 (diabetic retinopathy, retinal vein occlusion, retinal detachment, macular hole, macular epiretinal membrane, vitreous macular traction syndrome, optic nerve disease, etc.); 5. CNV caused by non-nAMD exists in the study eye (such as trauma, ocular histoplasmosis, vascular stripes, etc.); 6. The study eye has high myopia with diopter≥8D; 7. The study eye has poorly controlled glaucoma (defined as intraocular pressure≥25 mmHg after anti-glaucoma treatment), or has received glaucoma filtering surgery; 8. Vitreous hemorrhage in the study eye before randomization; 9. Any history of the following ophthalmic surgery in the study eye: vitrectomy, macular transposition; any evidence of external eye surgery within 1 month, cataract surgery within 2 months or other intraocular surgery within 3 months before randomization in the study eye; 10. Active inflammation or infection in either eye, such as conjunctivitis,keratitis, scleritis, or endophthalmitis, ect; 11. Previous IVT injection of any anti-VEGF drug into fellow eye within 3 months before randomization; 12. Fellow eye uses ETDRS testing to detect BCVA \<19 letters; 13. 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; 14. Abnormal liver and kidney function (ALT, AST≥2.5 times the upper limit of normal; total bilirubin≥1.5 times the upper limit of normal; serum creatinine≥1.5 times the upper limit of normal);Abnormal coagulation function(prothrombin time ≥ 3 seconds over ULN, activated partial thromboplastin time ≥ 10 seconds over ULN); 15. Poorly-controlled blood pressure (defined as: after receiving antihypertensive drugs, the subject's systolic value ≥160 mmHg or diastolic value ≥100 mmHg at seat); 16. History of a medical condition, including myocardial infarction, unstable angina pectoris, cerebrovascular accidents (including TIA), other thromboembolic diseases (such as thromboembolic angiitis, pulmonary embolism, deep vein thrombosis, portal vein thrombosis, etc.) within 6 months before randomization; 17. Any history of surgery within 1 month before randomization, and/or any currently unhealed wounds, ulcers, fractures, etc.; 18. Evidence of significant uncontrolled concomitant diseases such as cardiovascular diseases, nervous system diseases, respiratory system diseases, urinary system diseases, digestive system diseases and endocrine diseases before randomization; uncontrolled diabetes (defined as HbA1c\>10.0%);current treatment for active systemic infection; 19. 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. 20. Pregnant, lactating women and the patients who can not take contraceptive measures.
Where it's running
-
Beijing Tongren Hospital
Beijing, China Recruiting
Study contacts
- Study coordinator: Ming Guo
- Email: ming_guo@sinocelltech.com
- Phone: +86-10-58628288-9127
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Topical NT-101 in wet age-related macular degeneration
A topical eye drop (NT-101) is being tested to see if it can help people 50 and older with wet AMD when used twice daily for 12 weeks.
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SMZ1 plus ranibizumab vs placebo plus ranibizumab for wet AMD without PCV
A study tests whether SMZ1 tablets added to ranibizumab can give better vision improvement than placebo with ranibizumab in people 50 and older with a specific form of wet age-related macular degeneration.
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Early imaging changes with faricimab versus biosimilar ranibizumab for diabetic retinal disease
This trial will see if faricimab or a biosimilar ranibizumab causes different early OCT and OCTA imaging changes in adults with diabetic retinopathy or diabetic macular edema who need anti-VEGF injections.
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Comparing 8-week and 12-week follow-up intervals for treating wet AMD with faricimab
This study is testing whether patients with wet age-related macular degeneration can benefit more from follow-up treatments every 8 weeks or every 12 weeks after their initial injections of faricimab.
-
Long-term follow-up of EXG102-031 treatment for wet age-related macular degeneration
This follow-up will monitor people who previously received the EXG102-031 gene therapy for wet AMD to see if the treatment remains safe and continues to work over five years.
-
Port Delivery System with ranibizumab refilled every 36 weeks for neovascular (wet) AMD
This trial tests whether a refillable eye implant that delivers ranibizumab every 36 weeks works and is safe for people with recent neovascular (wet) age-related macular degeneration who responded to prior anti-VEGF injections.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.