Study to Compare Efficacy and Safety of LUBT010 and Lucentis® in Patients With Neovascular AMD

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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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

Conditions
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Neovascular Age-related Macular Degeneration

Intervention / Treatment
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* Drug: Lucentis (ranibizumab)
* Drug: LUBT010 (proposed ranibizumab biosimilar)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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-VEGF naïve) active CNV lesions involving the foveal center secondary to AMD 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lucentis (ranibizumab)<br>Intravitreal injection | Drug: Lucentis (ranibizumab)<br>* Lucentis® 0.5 mg via intravitreal injection once monthly<br>|
| Experimental: LUBT010 (proposed ranibizumab biosimilar)<br>Intravitreal injection | Drug: LUBT010 (proposed ranibizumab biosimilar)<br>* LUBT010 (proposed ranibizumab biosimilar) 0.5 mg via intravitreal injection once monthly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in BCVA from baseline in the study eye at the end of 12, months assessed with the ETDRS chart |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in BCVA from baseline in the study eye accessed with the ETDRS chart |  | 3 months, 6 months and 9 months | 
| Proportion of patients with anti-drug antibodies |  | 1, 3, 6, 9, and 12 months | 
| Adverse Events (AEs) | Number of patients with treatment-emergent adverse events | Baseline to 12 months | 
| Ophthalmic examination | Number of patients with clinically significant ophthalmic examination findings | Baseline to 12 months | 
| Physical & systemic examination | Number of patients with clinically significant physical & systemic examination findings. | Baseline to 12 months | 
| Vital Signs | Number of patients with clinically significant vital signs findings | Baseline to 12 months | 
| ECGs | Number of patients with clinically significant ECG findings | Baseline to 12 months | 
| Clinical Laboratory Tests | Number of patients with clinically significant laboratory test findings | Baseline to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neovascular age-related macular degeneration, Ranibizumab