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

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ClinicalTrials.gov Identifier: NCT04690556
Recruitment Status : Recruiting
First Posted : December 30, 2020
Last Update Posted : March 5, 2021
Sponsor:
Information provided by (Responsible Party):
Lupin Ltd.

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Neovascular Age-related Macular Degeneration Drug: Lucentis (ranibizumab) Drug: LUBT010 (proposed ranibizumab biosimilar) Phase 3

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : September 14, 2020
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Lucentis (ranibizumab)
Intravitreal injection
 Drug: Lucentis (ranibizumab)
Lucentis® 0.5 mg via intravitreal injection once monthly
Experimental: LUBT010 (proposed ranibizumab biosimilar)
Intravitreal injection
 Drug: LUBT010 (proposed ranibizumab biosimilar)
LUBT010 (proposed ranibizumab biosimilar) 0.5 mg via intravitreal injection once monthly


Outcome Measures
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Primary Outcome Measures :
  1. Mean change in BCVA from baseline in the study eye at the end of 12, months assessed with the ETDRS chart [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Mean change in BCVA from baseline in the study eye accessed with the ETDRS chart [ Time Frame: 3 months, 6 months and 9 months ]
  2. Proportion of patients with anti-drug antibodies [ Time Frame: 1, 3, 6, 9, and 12 months ]
  3. Adverse Events (AEs) [ Time Frame: Baseline to 12 months ]
    Number of patients with treatment-emergent adverse events

  4. Ophthalmic examination [ Time Frame: Baseline to 12 months ]
    Number of patients with clinically significant ophthalmic examination findings

  5. Physical & systemic examination [ Time Frame: Baseline to 12 months ]
    Number of patients with clinically significant physical & systemic examination findings.

  6. Vital Signs [ Time Frame: Baseline to 12 months ]
    Number of patients with clinically significant vital signs findings

  7. ECGs [ Time Frame: Baseline to 12 months ]
    Number of patients with clinically significant ECG findings

  8. Clinical Laboratory Tests [ Time Frame: Baseline to 12 months ]
    Number of patients with clinically significant laboratory test findings


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 foveal center secondary to AMD
  4. 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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04690556


Contacts
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Contact: Dhananjay Bakhle, M.B.B.S, M.D 91-20-66749000 ext 49054 dhananjaybakhle@lupin.com

Locations
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Sponsors and Collaborators
Lupin Ltd.
More Information
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Responsible Party: Lupin Ltd.
ClinicalTrials.gov Identifier: NCT04690556    
Other Study ID Numbers: LRP/LUBT010/2016/008
2017-004409-42 ( EudraCT Number )
First Posted: December 30, 2020    Key Record Dates
Last Update Posted: March 5, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lupin Ltd.:
Neovascular age-related macular degeneration, Ranibizumab
Additional relevant MeSH terms:
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Ranibizumab
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
 Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents