Home » Trials » SLCTR/2022/006
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
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SLCTR Registration Number
SLCTR/2022/006
Date of Registration
The date of last modification
Oct 04, 2024
Scientific Title of Trial
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
Public Title of Trial
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
Disease or Health Condition(s) Studied
Neovascular Age-Related Macular Degeneration
Scientific Acronym
LRP/LUBT010/2016/008
Public Acronym
None
Brief 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.
Universal Trial Number
U1111-1275-1785
Any other number(s) assigned to the trial and issuing authority
EudraCT number:2017-004409-42 ClinicalTrials.gov Identifier: NCT04690556
What is the research question being addressed?
Is there equivalence in efficacy, safety, tolerability and immunogenicity of LUBT010 to Lucentis® in terms of visual acuity, in patients with Neovascular Age-Related Macular Degeneration?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded : Participants, Investigators, Healthcare providers
Control
Active
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 3
Intervention(s) planned
The study settings include Durdans Hospital, Colombo 03, National Eye Hospital, Colombo 10, The National Hospital Kandy, Kandy, Jaffna Teaching Hospital, Jaffna and Sri Jayewardenepura General Hospital, Nugegoda.
Method of randomization is block randomization, which is managed by automated Interactive Web Response Systems (IWRS) system.
Eligible patients with Neovascular age related macular degeneration (AMD) will be randomly assigned to receive either LUBT010 (biosimilar of ranibizumab) 0.5 mg (0.05 mL of 10 mg/mL ranibizumab) once monthly (intravitreal injection) or Lucentis® 0.5 mg (0.05 mL of 10 mg/mL ranibizumab) once monthly (intravitreal injection) for 12 months. Patients will be randomized on Day 1. Only one eye per patient will receive the investigational product (IP).
Patients will visit site for a safety visit after the first dose on any one day from Day 2 to Day 9, followed by the next visit on Day 31 ± 2 days, and thereafter monthly for a total of 12 months (i.e. Day 61, Day 91, Day 121, Day 151, Day 181, Day 211, Day 241, Day 271, Day 301, Day 331, and Day 360), with an allowable visit window period of ± 2 days. A post injection visit/ telephonic safety assessment after every injection will be done as deemed necessary by Investigator. Efficacy, safety, and immunogenicity assessments will be done periodically. Day 360 ± 2 will be End of Study (EOS) visit.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
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(s)
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) (Number of patients with clinically significant ophthalmic examination findings) |
[ Time Frame: Baseline to 12 months ] |
4.
Physical & systemic examination (Number of patients with clinically significant physical & systemic examination findings) |
[ Time Frame: Baseline to 12 months ] |
5.
Vital Signs (Number of patients with clinically significant vital signs findings) |
[ Time Frame: Baseline to 12 months ] |
6.
ECGs (Number of patients with clinically significant ECG findings) |
[ Time Frame: Baseline to 12 months ] |
7.
Clinical Laboratory Tests (Number of patients with clinically significant laboratory test findings) |
[ Time Frame: Baseline to 12 months ] |
8.
Ophthalmic examination (Number of patients with clinically significant ophthalmic examination findings) |
[ Time Frame: Baseline to 12 months ] |
Target number/sample size
22 (11 in each group)
Countries of recruitment
Bulgaria, Hungary, India, Poland, Slovakia, Ukraine, United States
Anticipated start date
2022-04-05
Anticipated end date
2024-01-05
Date of first enrollment
Date of study completion
Recruitment status
Withdrawn
Funding source
Lupin Limited (Biotechnology Division), Jasmine Building, 159, C S T Road, Kalina, Santacruz (E), Mumbai, Maharashtra 400098
Regulatory approvals
Pending
Status
Approved
Date of Approval
2022-01-11
Approval number
P/203/12/2021
Details of Ethics Review Committee
Name: | Ethics Review Committee Faculty of Medicine University of Kelaniya |
Institutional Address: | Ethics Review Committee University of Kelaniya, P.O Box 6, Thalagolla Road, Ragama, Sri Lanka |
Telephone: | +94 11 2961267 |
Email: | ercmed@kln.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Dr Charith Fonseka
Consultant Eye surgeon
charith.fonseka@gmail.com
+94 115 410 000
+94777777570
charith.fonseka@gmail.com
Contact Person for Public Queries
Dr Charith Fonseka
Consultant Eye surgeon
charith.fonseka@gmail.com
+94 115 410 000
+94777777570
charith.fonseka@gmail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
N/A
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
Study was withdrawn from Sri Lanka before commencement.