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Clinical Study to Compare Efficacy and Safety of AVT06 and EU-Eylea (ALVOEYE)

NCT05155293 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 413

Last updated 2024-09-27

No results posted yet for this study

Summary

This is a randomized, double-masked, parallel-group, multicenter, therapeutic equivalence study evaluating the efficacy, safety, and immunogenicity of AVT06 compared with Eylea in subjects with neovascular (wet) AMD.

Conditions

  • Neovascular (Wet) AMD

Interventions

DRUG

AVT06 (proposed aflibercept biosimilar)

Patients will receive IVT injections of AVT06

DRUG

Eylea® (Aflibercept)

Patients will receive IVT injections of Eylea®

Sponsors & Collaborators

  • Alvotech Swiss AG

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-28
Primary Completion
2023-11-17
Completion
2024-09-23

Countries

  • Czechia
  • Georgia
  • Japan
  • Latvia
  • Slovakia

Study Locations

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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 NCT05155293 on ClinicalTrials.gov