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

Last updated: August 6, 2024
Sponsor: Lupin Ltd.
Overall Status: Completed

Phase

3

Condition

Geographic Atrophy

Macular Degeneration

Treatment

Lucentis (ranibizumab)

LUBT010 (proposed ranibizumab biosimilar)

Clinical Study ID

NCT04690556
LRP/LUBT010/2016/008
2017-004409-42
  • Ages > 50
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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-VEGF naïve) active CNV lesions involving the fovealcenter secondary to AMD

  4. BCVA between 20/40 and 20/200 (Snellen equivalent) in the study eye, using ETDRStesting

  5. Willingness and ability to undertake all scheduled visits and assessments

Exclusion

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

Study Design

Total Participants: 600
Treatment Group(s): 2
Primary Treatment: Lucentis (ranibizumab)
Phase: 3
Study Start date:
September 14, 2020
Estimated Completion Date:
May 31, 2024

Study 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.

Connect with a study center

  • The Eye Care Center

    Guwahati, Assam 781003
    India

    Site Not Available

  • Government Eye Hospital M & J Institute of Ophthalmology

    Ahmedabad, Gujarat 380016
    India

    Site Not Available

  • Rising Retina Clinic

    Ahmedabad, Gujarat 380015
    India

    Site Not Available

  • Kanoria Hospital and Research Center

    Gandhinagar, Gujarat 382428
    India

    Site Not Available

  • Kiran Hospital Multi Super Speciality Hospital & Research Centre

    Sūrat, Gujarat 395004
    India

    Site Not Available

  • Shivam Retina Clinic and Eye Hospital

    Sūrat, Gujarat 395001
    India

    Site Not Available

  • Kashyap Memorial Eye Hospital Pvt. Ltd.

    Ranchi, Jharkhand 834001
    India

    Site Not Available

  • Nethra Eye Hospital

    Bangalore, Karnataka 560094
    India

    Site Not Available

  • JSS Hospital

    Mysore, Karnataka 570004
    India

    Site Not Available

  • Mysore Medical College and Research Institute

    Mysore, Karnataka 570001
    India

    Site Not Available

  • Kamalnayan Bajaj Hospital

    Aurangabad, Maharashtra 431010
    India

    Site Not Available

  • Aditya Jyot Eye Hospital Pvt. Ltd.

    Mumbai, Maharashtra 400031
    India

    Site Not Available

  • Anideep Eye Hospital

    Mumbai, Maharashtra 400056
    India

    Site Not Available

  • Shroff Eye Hospital & Vision Research Centre

    Mumbai, Maharashtra 400050
    India

    Site Not Available

  • Topiwala National Medical College & B. Y. L. Nair Charitable Hospital

    Mumbai, Maharashtra 400056
    India

    Site Not Available

  • Dhadiwal Hospital in Coalition with Shreeji Healthcare

    Nashik, Maharashtra 422002
    India

    Site Not Available

  • Vijay Vallabh Hospital and Medical Research Center

    Palghar, Maharashtra 401303
    India

    Site Not Available

  • Insight Institute of Ophthalmology

    Pune, Maharashtra 411039
    India

    Site Not Available

  • Advanced Eye Centre Post Graduate Institute of Medical Education & Research

    Chandigarh, Punjab 160012
    India

    Site Not Available

  • Dr. J L Rohatgi Memorial Eye Hospital

    Kanpur, Uttar Pradesh 208005
    India

    Site Not Available

  • King George's Medical University

    Lucknow, Uttar Pradesh 226003
    India

    Site Not Available

  • R.K.Netralaya Eye Hospital (P) Ltd.

    Varanasi, Uttar Pradesh 221010
    India

    Site Not Available

  • Regional Institute of Ophthalmology

    Kolkata, West Bengal 700073
    India

    Site Not Available

  • Aakash Healthcare Super Specialty Hospital

    New Delhi, 110075
    India

    Site Not Available

  • Dr. Shroff's Charity Eye Hospital

    New Delhi, 110002
    India

    Site Not Available

  • Sir Ganga Ram Hosptial

    New Delhi, 110060
    India

    Site Not Available

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