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

Lupin

Status and phase: Completed; Phase 3

Conditions: Neovascular Age-related Macular Degeneration

Treatments: Drug: LUBT010 (proposed ranibizumab biosimilar); Drug: Lucentis (ranibizumab)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04690556

2017-004409-42 (EudraCT Number)

LRP/LUBT010/2016/008

Details and patient eligibility

About

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).

Full 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 degeneration.

Eligible patients will be randomly assigned in 1:1 ratio to receive once monthly intravitreal injection of LUBT010 or Lucentis® for 12 months.

Enrollment: 600 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Ambulatory male or female participants with age ≥ 50 years at the time of screening
2. Capable of understanding and giving written informed consent
3. Primary or recurrent (anti-vascular endothelial growth factor naïve) active choroidal neovascularization (CNV) lesions involving the foveal center secondary to AMD
4. Best corrected visual acuity (BCVA) between 20/40 and 20/200 (Snellen equivalent) in the study eye, using ETDRS testing
5. Willingness and ability to undertake all scheduled visits and assessments

Exclusion criteria

1. Known hypersensitivity to ranibizumab or any of the components of study medication
2. Known history of allergy to fluorescein dye
3. Scar, fibrosis, or atrophy involving the center of the fovea in the study eye
4. Subretinal hemorrhage in the study eye that involves the center of the fovea
5. Uncontrolled glaucoma
6. Use of prohibited treatments

Other In-/Exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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600 participants in 2 patient groups

Drug: LUBT010 (proposed ranibizumab biosimilar)

Experimental group

Treatment:

Drug: LUBT010 (proposed ranibizumab biosimilar)

Drug: Lucentis (ranibizumab)

Active Comparator group

Treatment:

Drug: Lucentis (ranibizumab)