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

  • STATUS
    Recruiting
  • End date
    Dec 24, 2021
  • participants needed
    580
  • sponsor
    Xbrane Biopharma AB
Updated on 1 August 2021
angiography
vegf
be 50
bevacizumab
vascular endothelial growth factor
ranibizumab
neovascularization
lucentis
corrected visual acuity
fluorescein angiography
optical coherence tomography
age-related macular degeneration

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).

Description

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.

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

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note