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

Primary Purpose

Neovascular Age-related Macular Degeneration

Status
Unknown status
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Lucentis (ranibizumab)
LUBT010 (proposed ranibizumab biosimilar)
Sponsored by
Lupin Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neovascular Age-related Macular Degeneration focused on measuring Neovascular age-related macular degeneration, Ranibizumab

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Eye Care Center
  • Rising Retina ClinicRecruiting
  • Government Eye Hospital M & J Institute of OphthalmologyRecruiting
  • Kanoria Hospital and Research CenterRecruiting
  • Shivam Retina Clinic and Eye HospitalRecruiting
  • Kiran Hospital Multi Super Speciality Hospital & Research Centre
  • Kashyap Memorial Eye Hospital Pvt. Ltd.
  • Nethra Eye HospitalRecruiting
  • Mysore Medical College and Research Institute
  • JSS HospitalRecruiting
  • Kamalnayan Bajaj Hospital
  • Aditya Jyot Eye Hospital Pvt. Ltd.Recruiting
  • Shroff Eye Hospital & Vision Research Centre
  • Anideep Eye Hospital
  • Topiwala National Medical College & B. Y. L. Nair Charitable Hospital
  • Dhadiwal Hospital in Coalition with Shreeji HealthcareRecruiting
  • Vijay Vallabh Hospital and Medical Research Center
  • Insight Institute of OphthalmologyRecruiting
  • Advanced Eye Centre Post Graduate Institute of Medical Education & ResearchRecruiting
  • Dr. J L Rohatgi Memorial Eye HospitalRecruiting
  • King George's Medical University
  • R.K.Netralaya Eye Hospital (P) Ltd.
  • Regional Institute of OphthalmologyRecruiting
  • Dr. Shroff's Charity Eye HospitalRecruiting
  • Sir Ganga Ram Hosptial
  • Aakash Healthcare Super Specialty Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Lucentis (ranibizumab)

LUBT010 (proposed ranibizumab biosimilar)

Arm Description

Intravitreal injection

Intravitreal injection

Outcomes

Primary Outcome Measures

Mean change in BCVA from baseline in the study eye at the end of 12, months assessed with the ETDRS chart

Secondary Outcome Measures

Mean change in BCVA from baseline in the study eye accessed with the ETDRS chart
Proportion of patients with anti-drug antibodies
Adverse Events (AEs)
Number of patients with treatment-emergent adverse events
Ophthalmic examination
Number of patients with clinically significant ophthalmic examination findings
Physical & systemic examination
Number of patients with clinically significant physical & systemic examination findings.
Vital Signs
Number of patients with clinically significant vital signs findings
ECGs
Number of patients with clinically significant ECG findings
Clinical Laboratory Tests
Number of patients with clinically significant laboratory test findings

Full Information

First Posted
November 23, 2020
Last Updated
March 3, 2021
Sponsor
Lupin Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04690556
Brief Title
Study to Compare Efficacy and Safety of LUBT010 and Lucentis® in Patients With Neovascular AMD
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 14, 2020 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lupin Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular Age-related Macular Degeneration
Keywords
Neovascular age-related macular degeneration, Ranibizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lucentis (ranibizumab)
Arm Type
Active Comparator
Arm Description
Intravitreal injection
Arm Title
LUBT010 (proposed ranibizumab biosimilar)
Arm Type
Experimental
Arm Description
Intravitreal injection
Intervention Type
Drug
Intervention Name(s)
Lucentis (ranibizumab)
Intervention Description
Lucentis® 0.5 mg via intravitreal injection once monthly
Intervention Type
Drug
Intervention Name(s)
LUBT010 (proposed ranibizumab biosimilar)
Intervention Description
LUBT010 (proposed ranibizumab biosimilar) 0.5 mg via intravitreal injection once monthly
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Mean change in BCVA from baseline in the study eye accessed with the ETDRS chart
Time Frame
3 months, 6 months and 9 months
Title
Proportion of patients with anti-drug antibodies
Time Frame
1, 3, 6, 9, and 12 months
Title
Adverse Events (AEs)
Description
Number of patients with treatment-emergent adverse events
Time Frame
Baseline to 12 months
Title
Ophthalmic examination
Description
Number of patients with clinically significant ophthalmic examination findings
Time Frame
Baseline to 12 months
Title
Physical & systemic examination
Description
Number of patients with clinically significant physical & systemic examination findings.
Time Frame
Baseline to 12 months
Title
Vital Signs
Description
Number of patients with clinically significant vital signs findings
Time Frame
Baseline to 12 months
Title
ECGs
Description
Number of patients with clinically significant ECG findings
Time Frame
Baseline to 12 months
Title
Clinical Laboratory Tests
Description
Number of patients with clinically significant laboratory test findings
Time Frame
Baseline to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 naïve) 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dhananjay Bakhle, M.B.B.S, M.D
Phone
91-20-66749000
Ext
49054
Email
dhananjaybakhle@lupin.com
Facility Information:
Facility Name
The Eye Care Center
City
Guwahati
State/Province
Assam
ZIP/Postal Code
781003
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Ronel Soibam, MS (Ophthal)
Facility Name
Rising Retina Clinic
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380015
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Rohan Chauhan, M.B.B.S D.O
Facility Name
Government Eye Hospital M & J Institute of Ophthalmology
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380016
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Jignesh Gosai, MS
Facility Name
Kanoria Hospital and Research Center
City
Gandhinagar
State/Province
Gujarat
ZIP/Postal Code
382428
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Ashish Saxena, MS (Ophthal)
Facility Name
Shivam Retina Clinic and Eye Hospital
City
Sūrat
State/Province
Gujarat
ZIP/Postal Code
395001
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Shobhana Mange, MS (Ophthal)
Facility Name
Kiran Hospital Multi Super Speciality Hospital & Research Centre
City
Sūrat
State/Province
Gujarat
ZIP/Postal Code
395004
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Kamlesh Patel, MBBS;MD
Facility Name
Kashyap Memorial Eye Hospital Pvt. Ltd.
City
Ranchi
State/Province
Jharkhand
ZIP/Postal Code
834001
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Bhibhuti Kashyap, MBBS; MD
Facility Name
Nethra Eye Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560094
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Natesh Sribhargava, MBBS;DNB
Facility Name
Mysore Medical College and Research Institute
City
Mysore
State/Province
Karnataka
ZIP/Postal Code
570001
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Satish K, MS (Ophthal)
Facility Name
JSS Hospital
City
Mysore
State/Province
Karnataka
ZIP/Postal Code
570004
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Premnath Raman, MS (Ophthal)
Facility Name
Kamalnayan Bajaj Hospital
City
Aurangabad
State/Province
Maharashtra
ZIP/Postal Code
431010
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Aniruddha Nalgirkar, MBBS;MS
Facility Name
Aditya Jyot Eye Hospital Pvt. Ltd.
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400031
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Jaydeep Walinjkar, MBBS; DNB
Facility Name
Shroff Eye Hospital & Vision Research Centre
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400050
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Rahul A Shroff, MS (Ophthal)
Facility Name
Anideep Eye Hospital
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400056
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Nita U Shanbhag, MS;FCPS
Facility Name
Topiwala National Medical College & B. Y. L. Nair Charitable Hospital
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400056
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Saroj Sahdev, MBBS;MS
Facility Name
Dhadiwal Hospital in Coalition with Shreeji Healthcare
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422002
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Anup Shah, MBBS;MD
Facility Name
Vijay Vallabh Hospital and Medical Research Center
City
Palghar
State/Province
Maharashtra
ZIP/Postal Code
401303
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Vinit Shah, MBBS;MD
Facility Name
Insight Institute of Ophthalmology
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411039
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Anjali Sapar, MBBS;MS;DNB
Facility Name
Advanced Eye Centre Post Graduate Institute of Medical Education & Research
City
Chandigarh
State/Province
Punjab
ZIP/Postal Code
160012
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Ramandeep Singh, MBBS;MS
Facility Name
Dr. J L Rohatgi Memorial Eye Hospital
City
Kanpur
State/Province
Uttar Pradesh
ZIP/Postal Code
208005
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Sukant Pandey, MS (Ophthal)
Facility Name
King George's Medical University
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226003
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Sandeep Saxena, MBBS;MS
Facility Name
R.K.Netralaya Eye Hospital (P) Ltd.
City
Varanasi
State/Province
Uttar Pradesh
ZIP/Postal Code
221010
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Atul K Sahu, MBBS;MS
Facility Name
Regional Institute of Ophthalmology
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700073
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Asim K Ghosh, MS (Ophthal)
Facility Name
Dr. Shroff's Charity Eye Hospital
City
New Delhi
ZIP/Postal Code
110002
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Manisha Agarwal, MBBS;MS;DNB
Facility Name
Sir Ganga Ram Hosptial
City
New Delhi
ZIP/Postal Code
110060
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Tinku B Razdan, MBBS;MS
Facility Name
Aakash Healthcare Super Specialty Hospital
City
New Delhi
ZIP/Postal Code
110075
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Vidya Nair, MD (Ophthal)

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make IPD available.

Learn more about this trial

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

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