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Study to Compare Efficacy, Safety, and Immunogenicity of LUBT010 (Proposed Ranibizumab Biosimilar) and Lucentis® in Patients With Neovascular AMD

NCT04690556 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2026-01-29

Study results available
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Summary

This study is designed to compare the efficacy, safety and immunogenicity of LUBT010 with Lucentis® given as once monthly intravitreal injection in patients with neovascular age-related macular degeneration (AMD).

Conditions

  • Neovascular Age-related Macular Degeneration

Interventions

DRUG

LUBT010 (proposed ranibizumab biosimilar)

LUBT010 (proposed ranibizumab biosimilar) 0.5 mg via intravitreal injection once monthly

DRUG

Lucentis (ranibizumab)

Lucentis® 0.5 mg via intravitreal injection once monthly

Sponsors & Collaborators

  • Lupin Ltd.

    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
2020-09-14
Primary Completion
2024-05-31
Completion
2024-05-31
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Hungary
  • India
  • Poland
  • Russia
  • 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 NCT04690556 on ClinicalTrials.gov