Study to Compare Efficacy, Safety, and Immunogenicity of LUBT010 (Proposed Ranibizumab Biosimilar) and Lucentis® in Patients With Neovascular AMD

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Lupin Ltd.
Study ID
NCT04690556
Phase
PHASE3
Status
Completed

Conditions

  • Neovascular Age-related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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 degeneration (AMD).

Key Dates

First listed
Dec 30, 2020
Start date
Sep 14, 2020
Status verified
Jan 2026
Primary completion
May 31, 2024
Completion
May 31, 2024

Study Design

Enrollment
600 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Drug: LUBT010 (proposed ranibizumab biosimilar)
  • Active Comparator: Drug: Lucentis (ranibizumab)

Primary Outcome Measure

Mean Change in BCVA From Baseline in the Study Eye at the End of 12 Months [ Time Frame: Baseline and 12 Months ]

Locations (6)

FacilityCityStateZIPSite coordinators
Retina-Vitreous Associates Medical GroupBeverly HillsCalifornia90211-
Bruce A. Segal, MD, PADelray BeachFlorida33484-
Cumberland Valley Retina Consultants, P.C.HagerstownMaryland21740-
UPMC Eye Center - Eye and Ear InstitutePittsburghPennsylvania15213-
Black Hills Regional Eye InstituteRapid CitySouth Dakota57701-
Valley Retina InstituteMcAllenTexas78503-

Find similar trials in Beverly Hills, CA

By research site
Retina-Vitreous Associates Medical Group· Beverly Hills, CABruce A. Segal, MD, PA· Delray Beach, FLCumberland Valley Retina Consultants, P.C.· Hagerstown, MDUPMC Eye Center - Eye and Ear Institute· Pittsburgh, PABlack Hills Regional Eye Institute· Rapid City, SDValley Retina Institute· McAllen, TX

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