This Study Will Compare the Efficacy and Safety of SCT510A Administered by Intravitreal Injection (IVT) With Ranibizumab in Patients With wAMD

NCT05480293 | Unknown Phase 3

• 1 other identifier: SCT510A-A301
• Study Type: interventional
• Target: 446
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the efficacy and safety of SCT510A versus Lucentis in the treatment of wet age-related macular degeneration.

Conditions

Wet Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline in BCVA at at Week 48

  Change from Baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study(ETDRS) letter score at week 48.

  up to at Week 48

Secondary Outcomes (4)

• Proportion of patients gaining at least 5，10，15 letters in the BCVA at Week 12, 24 and 48

  up to Week 12, 24 and 48

• Mean change from baseline in BCVA at at Week 12 and 24

  up to Week 12 and 24

• Mean change from baseline in CRT on OCT at Week 12, 24 and 48 (as measured by the Reading Center)

  up to Week 12,24 and 48

• Mean change from baseline in size of CNV and total area of fluorescein leakage from CNV on FA at Week 12 and 48 (as measured by the Reading Center)

  up to Week 12 and 48

Study Arms (2)

SCT510A

EXPERIMENTAL

SCT510A(1.25mg), Vitreous injection, injection once every 4 weeks

Drug: SCT510A

Ranibizumab

ACTIVE COMPARATOR

Ranibizumab(0.5mg), Vitreous injection, injection once every 4 weeks

Drug: Ranibizumab

Interventions

Ranibizumab DRUG

ranibizumab，0.5mg,IVT

Ranibizumab

SCT510A DRUG

SCT510A，1.25mg,IVT

SCT510A

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent form;
• Age≥45 years，male or femal;
• 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；
• The study eye has not received any anti-VEGF treatment within 3 months before randomization, such as ranibizumab, bevacizumab, conbercept, etc；

You may not qualify if:

• 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 afferent pupillary defect (APD) in the study eye；
• 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.
• 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.);
• CNV caused by non-nAMD exists in the study eye (such as trauma, ocular histoplasmosis, vascular stripes, etc.);
• The study eye has high myopia with diopter≥8D;
• The study eye has poorly controlled glaucoma (defined as intraocular pressure≥25 mmHg after anti-glaucoma treatment), or has received glaucoma filtering surgery;
• Vitreous hemorrhage in the study eye before randomization;
• 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;
• Active inflammation or infection in either eye, such as conjunctivitis,keratitis, scleritis, or endophthalmitis, ect；
• Previous IVT injection of any anti-VEGF drug into fellow eye within 3 months before randomization;
• Fellow eye uses ETDRS testing to detect BCVA \<19 letters;
• 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;
• 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）;
• Poorly-controlled blood pressure (defined as: after receiving antihypertensive drugs, the subject's systolic value ≥160 mmHg or diastolic value ≥100 mmHg at seat);

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

Study Sites (1)

Beijing Tongren Hospital

Beijing, China

RECRUITING

MeSH Terms

Interventions

Ranibizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Ming Guo

CONTACT

+86-10-58628288-9127; ming_guo@sinocelltech.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: July 29, 2022
• Study Start: February 14, 2023
• Primary Completion: July 31, 2025
• Study Completion: August 31, 2025
• Last Updated: February 16, 2023

Record last verified: 2022-05

Locations

CN (1)