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Completed

NCT Number: NCT04690556

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

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).

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Key information

Conditions

Neovascular Age-related Macular Degeneration

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medical Center Oxycom EOOD, Burgas, Bulgaria

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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-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 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

Treatment and study plan

LUBT010 (proposed ranibizumab biosimilar)

Drug

LUBT010 (proposed ranibizumab biosimilar) 0.5 mg via intravitreal injection once monthly

Lucentis (Ranibizumab)

Drug

Lucentis® 0.5 mg via intravitreal injection once monthly

Primary outcomes

  1. Mean Change in BCVA From Baseline in the Study Eye at the End of 12 Months

    Time frame: Baseline and 12 Months

    Early treatment diabetic retinopathy study (ETDRS) charts were used for visual acuity measurement

Secondary outcomes

  1. Mean Change in BCVA From Baseline in the Study Eye at the End of 3 Months

    Time frame: Baseline and 3 Months

    ETDRS charts were used for visual acuity measurement summarized descriptively by treatment arm and time point

  2. Mean Change in BCVA From Baseline in the Study Eye at the End of 6 Months

    Time frame: Baseline and 6 Months

    ETDRS charts were used for visual acuity measurement summarized descriptively by treatment arm and time point

  3. Mean Change in BCVA From Baseline in the Study Eye at the End of 9 Months

    Time frame: Baseline and 9 Months

    ETDRS charts were used for visual acuity measurement summarized descriptively by treatment arm and time point

Sponsors and collaborators

Lead sponsor

Lupin Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Dec 30, 2020
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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