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

  • STATUS
    Recruiting
  • End date
    Oct 15, 2022
  • participants needed
    600
  • sponsor
    Lupin Ltd.
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Updated on 15 March 2021
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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 degeneration (AMD).

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.

Details
Condition Neovascular Age-related Macular Degeneration, Neovascular Age-related Macular Degeneration, Neovascular Age-related Macular Degeneration, Neovascular Age Related Macular Degeneration
Treatment Lucentis (ranibizumab), LUBT010 (proposed ranibizumab biosimilar)
Clinical Study IdentifierNCT04690556
SponsorLupin Ltd.
Last Modified on15 March 2021

Eligibility

 Yes No Not Sure

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 nave) 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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