Status:
COMPLETED
Study to Compare Efficacy, Safety, and Immunogenicity of LUBT010 (Proposed Ranibizumab Biosimilar) and Lucentis® in Patients With Neovascular AMD
Lead Sponsor:
Lupin Ltd.
Conditions:
Neovascular Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief 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 degene...
Detailed Description
This is a global, phase III, double blind, randomized controlled study to compare the efficacy, safety \& immunogenicity of LUBT010 with Lucentis® in patients with neovascular age-related macular dege...
Eligibility Criteria
Inclusion
- Ambulatory male or female participants with age ≥ 50 years at the time of screening
- Capable of understanding and giving written informed consent
- Primary or recurrent (anti-vascular endothelial growth factor naïve) active choroidal neovascularization (CNV) lesions involving the foveal center secondary to AMD
- Best corrected visual acuity (BCVA) between 20/40 and 20/200 (Snellen equivalent) in the study eye, using ETDRS testing
- Willingness and ability to undertake all scheduled visits and assessments
Exclusion
- Known hypersensitivity to ranibizumab or any of the components of study medication
- Known history of allergy to fluorescein dye
- Scar, fibrosis, or atrophy involving the center of the fovea in the study eye
- Subretinal hemorrhage in the study eye that involves the center of the fovea
- Uncontrolled glaucoma
- Use of prohibited treatments
- Other In-/Exclusion criteria may apply
Key Trial Info
Start Date :
September 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2024
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04690556
Start Date
September 14 2020
End Date
May 31 2024
Last Update
January 6 2026
Active Locations (77)
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1
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
2
Bruce A. Segal, MD, PA
Delray Beach, Florida, United States, 33484
3
Cumberland Valley Retina Consultants, P.C.
Hagerstown, Maryland, United States, 21740
4
UPMC Eye Center - Eye and Ear Institute
Pittsburgh, Pennsylvania, United States, 15213