A Study to Comparing SCD411 and Eylea® in Subjects With Wet Age-related Macular Degeneration (AMD)

Part of paid clinical trials in Campbell, California.

Sponsor
Sam Chun Dang Pharm. Co. Ltd.
Study ID
NCT04480463
Phase
PHASE3
Status
Completed

Conditions

  • Neovascular Age-related Macular Degeneration
  • Wet Age-related Macular Degeneration

Eligibility Criteria

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

Interventions

  • SCD411 — DRUG
    IVT (intravitreal) injection
  • Aflibercept — DRUG
    IVT injection

Study Details

Age-related macular degeneration (AMD) is a leading cause of vision loss in adults. Abnormal blood vessels grow under the macula at the back of the eye, and also leak blood and fluid, which damages and scars the macula, affecting vision. The current standard of care for patients with neovascular (exudative / wet) AMD is anti-vascular endothelial growth factor (anti-VEGF) therapy, which prevents or slows down the growth of the abnormal blood vessels. SCD411 is being developed as a biosimilar to the reference product Eylea® (aflibercept), an anti-VEGF drug. The study aims to prove equivalence of SCD411 to Eylea in adults with wet AMD, and will look at safety, tolerance, effectiveness, immune response and the movement of the drug through the body.

Key Dates

Start date
Aug 13, 2020
Status verified
Oct 2023
Primary completion
Sep 8, 2022
Completion
Sep 8, 2022

Study Design

Enrollment
576 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SCD411
  • Active Comparator: Aflibercept

Primary Outcome Measure

Change From Baseline in BCVA (Best Corrected Visual Acuity) [ Time Frame: Baseline to Week 8 ]

Locations (12)

FacilityCityStateZIPSite coordinators
SCD Research SiteCampbellCalifornia95008-
SCD Research SiteClearwaterFlorida33761-
SCD Research SiteCoral SpringsFlorida33067-
SCD Research SiteFort MyersFlorida33912-
SCD Research SiteStuartFlorida34994-
SCD Research SiteMariettaGeorgia30060-
SCD Research SiteLemontIllinois60439-
SCD Research SiteLiverpoolNew York13088-
SCD Research SiteSpringfieldOregon97477-
SCD Research SiteRapid CitySouth Dakota57701-
SCD Research SiteAbileneTexas79606-
SCD Research SiteWillow ParkTexas76087-

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