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

NCT04480463 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 576

Last updated 2023-10-10

Study results available
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Summary

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.

Conditions

Interventions

DRUG

SCD411

IVT (intravitreal) injection

DRUG

Aflibercept

IVT injection

Sponsors & Collaborators

  • Sam Chun Dang Pharm. Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Byung Jhip Ha · Sam Chun Dang Pharm. Co. Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-13
Primary Completion
2022-09-08
Completion
2022-09-08
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Bulgaria
  • Czechia
  • Hungary
  • India
  • Israel
  • Japan
  • Latvia
  • Poland
  • Russia
  • Slovakia
  • South Korea
  • Spain

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04480463 on ClinicalTrials.gov