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

Neovascular Age-related Macular Degeneration Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04690556
• Other study ID #: LRP/LUBT010/2016/008
• Secondary ID: 2017-004409-42
• Status: Recruiting
• Phase: Phase 3
• Start date: September 14, 2020
• Est. completion date: October 2022

Study information

• Verified date: March 2021
• Source: Lupin Ltd.
• Contact: Dhananjay Bakhle, M.B.B.S, M.D
• Phone: 91-20-66749000
• Email: dhananjaybakhle[@]lupin.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• Lucentis (ranibizumab)
Lucentis® 0.5 mg via intravitreal injection once monthly
• LUBT010 (proposed ranibizumab biosimilar)
LUBT010 (proposed ranibizumab biosimilar) 0.5 mg via intravitreal injection once monthly

Locations

Country	Name	City	State
India	Government Eye Hospital M & J Institute of Ophthalmology	Ahmedabad	Gujarat
India	Rising Retina Clinic	Ahmedabad	Gujarat
India	Kamalnayan Bajaj Hospital	Aurangabad	Maharashtra
India	Nethra Eye Hospital	Bangalore	Karnataka
India	Advanced Eye Centre Post Graduate Institute of Medical Education & Research	Chandigarh	Punjab
India	Kanoria Hospital and Research Center	Gandhinagar	Gujarat
India	The Eye Care Center	Guwahati	Assam
India	Dr. J L Rohatgi Memorial Eye Hospital	Kanpur	Uttar Pradesh
India	Regional Institute of Ophthalmology	Kolkata	West Bengal
India	King George's Medical University	Lucknow	Uttar Pradesh
India	Aditya Jyot Eye Hospital Pvt. Ltd.	Mumbai	Maharashtra
India	Anideep Eye Hospital	Mumbai	Maharashtra
India	Shroff Eye Hospital & Vision Research Centre	Mumbai	Maharashtra
India	Topiwala National Medical College & B. Y. L. Nair Charitable Hospital	Mumbai	Maharashtra
India	JSS Hospital	Mysore	Karnataka
India	Mysore Medical College and Research Institute	Mysore	Karnataka
India	Dhadiwal Hospital in Coalition with Shreeji Healthcare	Nashik	Maharashtra
India	Aakash Healthcare Super Specialty Hospital	New Delhi
India	Dr. Shroff's Charity Eye Hospital	New Delhi
India	Sir Ganga Ram Hosptial	New Delhi
India	Vijay Vallabh Hospital and Medical Research Center	Palghar	Maharashtra
India	Insight Institute of Ophthalmology	Pune	Maharashtra
India	Kashyap Memorial Eye Hospital Pvt. Ltd.	Ranchi	Jharkhand
India	Kiran Hospital Multi Super Speciality Hospital & Research Centre	Surat	Gujarat
India	Shivam Retina Clinic and Eye Hospital	Surat	Gujarat
India	R.K.Netralaya Eye Hospital (P) Ltd.	Varanasi	Uttar Pradesh

Sponsors (1)

Lead Sponsor	Collaborator
Lupin Ltd.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in BCVA from baseline in the study eye at the end of 12, months assessed with the ETDRS chart		12 months
Secondary	Mean change in BCVA from baseline in the study eye accessed with the ETDRS chart		3 months, 6 months and 9 months
Secondary	Proportion of patients with anti-drug antibodies		1, 3, 6, 9, and 12 months
Secondary	Adverse Events (AEs)	Number of patients with treatment-emergent adverse events	Baseline to 12 months
Secondary	Ophthalmic examination	Number of patients with clinically significant ophthalmic examination findings	Baseline to 12 months
Secondary	Physical & systemic examination	Number of patients with clinically significant physical & systemic examination findings.	Baseline to 12 months
Secondary	Vital Signs	Number of patients with clinically significant vital signs findings	Baseline to 12 months
Secondary	ECGs	Number of patients with clinically significant ECG findings	Baseline to 12 months
Secondary	Clinical Laboratory Tests	Number of patients with clinically significant laboratory test findings	Baseline to 12 months