Trials / Completed
CompletedNCT03805100
Comparing the Efficacy and Safety of Biosimilar Candidate Xlucane Versus Lucentis® in Patients With nAMD
A Phase III Double-Blind, Parallel Group, Multicenter Study to Compare the Efficacy and Safety of Xlucane Versus Lucentis® in Patients With Neovascular Age-Related Macular Degeneration
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 582 (actual)
- Sponsor
- Xbrane Biopharma AB · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
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).
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Ranibizumab | Intravitreal injection |
Timeline
- Start date
- 2019-04-19
- Primary completion
- 2021-05-11
- Completion
- 2021-11-11
- First posted
- 2019-01-15
- Last updated
- 2023-11-13
- Results posted
- 2023-11-13
Locations
102 sites across 15 countries: United States, Bulgaria, Czechia, Estonia, Hungary, India, Israel, Latvia, Lithuania, Poland, Romania, Russia, Slovakia, Spain, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03805100. Inclusion in this directory is not an endorsement.