Last updated on July 2020

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

Brief description of study

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

Detailed Study Description

Subjects will be randomised in a 1:1 ratio to receive either SB15 or Eylea (administered via intravitreal [IVT] injection 2 mg [0.05 mL] every 4 weeks for the first 3 months (i.e., at Weeks 0, 4, and 8), followed by 2 mg [0.05 mL] once every 8 weeks). At Week 32, subjects in Eylea treatment group will be randomised again in a 1:1 ratio to either continue on Eylea treatment or be transitioned to SB15 treatment. In the 8-week treatment cycle, IPs (SB15 or Eylea) will be administered up to Week 48, and the last assessment will be done at Week 56, corresponding to the end of follow-up for all subjects.

Clinical Study Identifier: NCT04450329

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SB Investigative Site

Szeged, Hungary
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Recruitment Status: Open

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