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

Sponsor
Sinocelltech Ltd.
Study ID
NCT05480293
Phase
PHASE3
Status
Unknown

Conditions

  • Wet Age-related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
45 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ranibizumab — DRUG
    ranibizumab，0.5mg,IVT
  • SCT510A — DRUG
    SCT510A，1.25mg,IVT

Study Details

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.

Key Dates

First listed
Jul 29, 2022
Start date
Feb 14, 2023
Status verified
May 2022
Primary completion
Jul 31, 2025
Completion
Aug 31, 2025

Study Design

Enrollment
446 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SCT510A
    SCT510A(1.25mg), Vitreous injection, injection once every 4 weeks
  • Active Comparator: Ranibizumab
    Ranibizumab(0.5mg), Vitreous injection, injection once every 4 weeks

Primary Outcome Measure

Mean change from baseline in BCVA at at Week 48 [ Time Frame: up to at Week 48 ]

Central Contacts

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