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

March 3, 2021 updated by: Lupin Ltd.

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
      • New Delhi, India, 110002
        • Recruiting
        • Dr. Shroff's Charity Eye Hospital
        • Contact:
          • Dr. Manisha Agarwal, MBBS;MS;DNB
      • New Delhi, India, 110060
        • Not yet recruiting
        • Sir Ganga Ram Hosptial
        • Contact:
          • Dr. Tinku B Razdan, MBBS;MS
      • New Delhi, India, 110075
        • Not yet recruiting
        • Aakash Healthcare Super Specialty Hospital
        • Contact:
          • Dr. Vidya Nair, MD (Ophthal)
    • Assam
      • Guwahati, Assam, India, 781003
        • Not yet recruiting
        • The Eye Care Center
        • Contact:
          • Dr. Ronel Soibam, MS (Ophthal)
    • Gujarat
      • Ahmedabad, Gujarat, India, 380015
        • Recruiting
        • Rising Retina Clinic
        • Contact:
          • Dr Rohan Chauhan, M.B.B.S D.O
      • Ahmedabad, Gujarat, India, 380016
        • Recruiting
        • Government Eye Hospital M & J Institute of Ophthalmology
        • Contact:
          • Dr. Jignesh Gosai, MS
      • Gandhinagar, Gujarat, India, 382428
        • Recruiting
        • Kanoria Hospital and Research Center
        • Contact:
          • Dr. Ashish Saxena, MS (Ophthal)
      • Sūrat, Gujarat, India, 395001
        • Recruiting
        • Shivam Retina Clinic and Eye Hospital
        • Contact:
          • Dr. Shobhana Mange, MS (Ophthal)
      • Sūrat, Gujarat, India, 395004
        • Not yet recruiting
        • Kiran Hospital Multi Super Speciality Hospital & Research Centre
        • Contact:
          • Dr. Kamlesh Patel, MBBS;MD
    • Jharkhand
      • Ranchi, Jharkhand, India, 834001
        • Not yet recruiting
        • Kashyap Memorial Eye Hospital Pvt. Ltd.
        • Contact:
          • Dr. Bhibhuti Kashyap, MBBS; MD
    • Karnataka
      • Bangalore, Karnataka, India, 560094
        • Recruiting
        • Nethra Eye Hospital
        • Contact:
          • Dr. Natesh Sribhargava, MBBS;DNB
      • Mysore, Karnataka, India, 570001
        • Not yet recruiting
        • Mysore Medical College and Research Institute
        • Contact:
          • Dr Satish K, MS (Ophthal)
      • Mysore, Karnataka, India, 570004
        • Recruiting
        • JSS Hospital
        • Contact:
          • Dr. Premnath Raman, MS (Ophthal)
    • Maharashtra
      • Aurangabad, Maharashtra, India, 431010
        • Not yet recruiting
        • Kamalnayan Bajaj Hospital
        • Contact:
          • Dr. Aniruddha Nalgirkar, MBBS;MS
      • Mumbai, Maharashtra, India, 400031
        • Recruiting
        • Aditya Jyot Eye Hospital Pvt. Ltd.
        • Contact:
          • Dr. Jaydeep Walinjkar, MBBS; DNB
      • Mumbai, Maharashtra, India, 400050
        • Not yet recruiting
        • Shroff Eye Hospital & Vision Research Centre
        • Contact:
          • Dr. Rahul A Shroff, MS (Ophthal)
      • Mumbai, Maharashtra, India, 400056
        • Not yet recruiting
        • Anideep Eye Hospital
        • Contact:
          • Dr. Nita U Shanbhag, MS;FCPS
      • Mumbai, Maharashtra, India, 400056
        • Not yet recruiting
        • Topiwala National Medical College & B. Y. L. Nair Charitable Hospital
        • Contact:
          • Dr. Saroj Sahdev, MBBS;MS
      • Nashik, Maharashtra, India, 422002
        • Recruiting
        • Dhadiwal Hospital in coalition with Shreeji Healthcare
        • Contact:
          • Dr. Anup Shah, MBBS;MD
      • Palghar, Maharashtra, India, 401303
        • Not yet recruiting
        • Vijay Vallabh Hospital and Medical Research Center
        • Contact:
          • Dr. Vinit Shah, MBBS;MD
      • Pune, Maharashtra, India, 411039
        • Recruiting
        • Insight Institute of Ophthalmology
        • Contact:
          • Dr. Anjali Sapar, MBBS;MS;DNB
    • Punjab
      • Chandigarh, Punjab, India, 160012
        • Recruiting
        • Advanced Eye Centre Post Graduate Institute of Medical Education & Research
        • Contact:
          • Dr. Ramandeep Singh, MBBS;MS
    • Uttar Pradesh
      • Kanpur, Uttar Pradesh, India, 208005
        • Recruiting
        • Dr. J L Rohatgi Memorial Eye Hospital
        • Contact:
          • Dr Sukant Pandey, MS (Ophthal)
      • Lucknow, Uttar Pradesh, India, 226003
        • Not yet recruiting
        • King George's Medical University
        • Contact:
          • Dr. Sandeep Saxena, MBBS;MS
      • Varanasi, Uttar Pradesh, India, 221010
        • Not yet recruiting
        • R.K.Netralaya Eye Hospital (P) Ltd.
        • Contact:
          • Dr. Atul K Sahu, MBBS;MS
    • West Bengal
      • Kolkata, West Bengal, India, 700073
        • Recruiting
        • Regional Institute of Ophthalmology
        • Contact:
          • Dr. Asim K Ghosh, MS (Ophthal)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
Time Frame: 3 months, 6 months and 9 months
3 months, 6 months and 9 months
Proportion of patients with anti-drug antibodies
Time Frame: 1, 3, 6, 9, and 12 months
1, 3, 6, 9, and 12 months
Adverse Events (AEs)
Time Frame: Baseline to 12 months
Number of patients with treatment-emergent adverse events
Baseline to 12 months
Ophthalmic examination
Time Frame: Baseline to 12 months
Number of patients with clinically significant ophthalmic examination findings
Baseline to 12 months
Physical & systemic examination
Time Frame: Baseline to 12 months
Number of patients with clinically significant physical & systemic examination findings.
Baseline to 12 months
Vital Signs
Time Frame: Baseline to 12 months
Number of patients with clinically significant vital signs findings
Baseline to 12 months
ECGs
Time Frame: Baseline to 12 months
Number of patients with clinically significant ECG findings
Baseline to 12 months
Clinical Laboratory Tests
Time Frame: Baseline to 12 months
Number of patients with clinically significant laboratory test findings
Baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lupin Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2020

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

November 23, 2020

First Submitted That Met QC Criteria

December 29, 2020

First Posted (Actual)

December 30, 2020

Study Record Updates

Last Update Posted (Actual)

March 5, 2021

Last Update Submitted That Met QC Criteria

March 3, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LRP/LUBT010/2016/008
  • 2017-004409-42 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There is not a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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