A Study to Compare SB15 (Proposed Aflibercept Biosimilar) to Eylea in Subjects With Neovascular Age-related Macular Degeneration (AMD)

Part of paid clinical trials in Colorado Springs, Colorado.

Sponsor
Samsung Bioepis Co., Ltd.
Study ID
NCT04450329
Phase
PHASE3
Status
Completed

Conditions

  • Neovascular Age-related Macular Degeneration

Eligibility Criteria

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

Interventions

  • SB15 (Proposed aflibercept biosimilar) — DRUG
    Subjects randomized into SB15 group will receive SB15 2 mg (0.05 mL) via intravitreal injection every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) once every 8 weeks until Week 48. Starting at Week 32, subjects transited from Eylea to SB15 will receive SB15 2 mg (0.05 mL) via intravitreal injection every 8 weeks.
  • Eylea (Aflibercept) — DRUG
    Subjects randomized into Eylea group will receive Eylea 2 mg (0.05 mL) via intravitreal injection every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) once every 8 weeks until Week 48.

Study Details

This is a randomised, double-masked, parallel group, multicentre study to evaluate the efficacy, safety, Pharmacokinetics (PK), and immunogenicity of SB15 compared to Eylea® in subjects with neovascular AMD.

Key Dates

Start date
Jun 23, 2020
Status verified
Feb 2024
Primary completion
Apr 15, 2021
Completion
Mar 16, 2022

Study Design

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

Arms

  • Experimental: SB15 (Proposed aflibercept biosimilar)
    Subjects randomized into SB15 group will receive SB15 2 mg (0.05 mL) via intravitreal injection every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) once every 8 weeks until Week 48.
  • Active Comparator: Eylea (Aflibercept)
    Subjects randomized into Eylea group will receive Eylea 2 mg (0.05 mL) via intravitreal injection every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) once every 8 weeks until Week 48. At Week 32, subjects in Eylea group will re-randomized into SB15 or Eylea group. After re-randomization, subjects transited to SB15 group will receive SB15 2 mg (0.05 mL) once every 8 weeks until Week 48 and subjects remaining in Eylea group will continue to receive Eylea 2 mg (0.05 mL) once every 8 weeks until Week 48.

Primary Outcome Measure

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

Locations (3)

FacilityCityStateZIPSite coordinators
SB Investigative SiteColorado SpringsColorado80909-
SB Investigative SiteChevy ChaseMaryland20815-
SB Investigative SiteAbileneTexas79606-

Find similar trials in Colorado Springs, CO

By research site
SB Investigative Site· Colorado Springs, COSB Investigative Site· Chevy Chase, MDSB Investigative Site· Abilene, TX

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