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Comparing the Efficacy and Safety of Biosimilar Candidate Xlucane Versus Lucentis® in Patients With nAMD

NCT03805100 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 582

Last updated 2023-11-13

Study results available
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Summary

The objectives of the study are to demonstrate the equivalence of Xlucane to Lucentis® in treatment of subjects with wet (ie, neovascular) age-related macular degeneration (wAMD).

Conditions

  • Macular Degeneration

Interventions

BIOLOGICAL

Ranibizumab

Intravitreal injection

Sponsors & Collaborators

  • Stada Arzneimittel AG

    collaborator INDUSTRY

  • Xbrane Biopharma AB

    lead INDUSTRY

Principal Investigators

  • Anat Loewenstein, Professor · Tel-Aviv Sourasky Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-19
Primary Completion
2021-05-11
Completion
2021-11-11
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Czechia
  • Estonia
  • Hungary
  • India
  • Israel
  • Latvia
  • Lithuania
  • Poland
  • Romania
  • Russia
  • Slovakia
  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

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 NCT03805100 on ClinicalTrials.gov