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

  • End date
    Dec 24, 2021
  • participants needed
  • sponsor
    Xbrane Biopharma AB
Updated on 1 August 2021
be 50
vascular endothelial growth factor
corrected visual acuity
fluorescein angiography
optical coherence tomography
age-related macular degeneration


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).


This is a phase III multicenter, double-masked, randomized, parallel group study in subjects with wAMD. Approximately 580 subjects will be enrolled and randomized in a 1:1 ratio to receive either Lucentis or the investigational product, Xlucane in the study eye once every 4 weeks for 52 weeks. The study eye will be defined as the eye meeting the enrollment criteria. The assigned study drug will be administered as an ophthalmic intravitreal (IVT) injection. A subgroup of 60 subjects at a select number of participating sites will be sequentially asked to participate in an evaluation of PK.

Condition age-related macular degeneration, Maculopathy, Macular Degeneration
Treatment ranibizumab
Clinical Study IdentifierNCT03805100
SponsorXbrane Biopharma AB
Last Modified on1 August 2021

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