Clinical trial NCT04690556: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neovascular Age-related Macular Degeneration
Keywords: Neovascular age-related macular degeneration, Ranibizumab
Lead sponsor: Lupin Ltd.
Sponsor class: INDUSTRY
First posted: 2020-12-30
Enrollment: 600
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Mean change in BCVA from baseline in the study eye at the end of 12, months assessed with the ETDRS chart
timeFrame: 12 months
Secondary outcomes:
measure: Mean change in BCVA from baseline in the study eye accessed with the ETDRS chart
timeFrame: 3 months, 6 months and 9 months
measure: Proportion of patients with anti-drug antibodies
timeFrame: 1, 3, 6, 9, and 12 months
measure: Adverse Events (AEs)
timeFrame: Baseline to 12 months
measure: Ophthalmic examination
timeFrame: Baseline to 12 months
measure: Physical & systemic examination
timeFrame: Baseline to 12 months
measure: Vital Signs
timeFrame: Baseline to 12 months
measure: ECGs
timeFrame: Baseline to 12 months
measure: Clinical Laboratory Tests
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: Guwahati
country: India
facility: The Eye Care Center
state: Assam
city: Ahmedabad
country: India
facility: Rising Retina Clinic
state: Gujarat
city: Ahmedabad
country: India
facility: Government Eye Hospital M & J Institute of Ophthalmology
state: Gujarat
city: Gandhinagar
country: India
facility: Kanoria Hospital and Research Center
state: Gujarat
city: Sūrat
country: India
facility: Shivam Retina Clinic and Eye Hospital
state: Gujarat
city: Sūrat
country: India
facility: Kiran Hospital Multi Super Speciality Hospital & Research Centre
state: Gujarat
city: Ranchi
country: India
facility: Kashyap Memorial Eye Hospital Pvt. Ltd.
state: Jharkhand
city: Bangalore
country: India
facility: Nethra Eye Hospital
state: Karnataka
city: Mysore
country: India
facility: Mysore Medical College and Research Institute
state: Karnataka
city: Mysore
country: India
facility: JSS Hospital
state: Karnataka
city: Aurangabad
country: India
facility: Kamalnayan Bajaj Hospital
state: Maharashtra
city: Mumbai
country: India
facility: Aditya Jyot Eye Hospital Pvt. Ltd.
state: Maharashtra
city: Mumbai
country: India
facility: Shroff Eye Hospital & Vision Research Centre
state: Maharashtra
city: Mumbai
country: India
facility: Anideep Eye Hospital
state: Maharashtra
city: Mumbai
country: India
facility: Topiwala National Medical College & B. Y. L. Nair Charitable Hospital
state: Maharashtra
city: Nashik
country: India
facility: Dhadiwal Hospital in Coalition with Shreeji Healthcare
state: Maharashtra
city: Palghar
country: India
facility: Vijay Vallabh Hospital and Medical Research Center
state: Maharashtra
city: Pune
country: India
facility: Insight Institute of Ophthalmology
state: Maharashtra
city: Chandigarh
country: India
facility: Advanced Eye Centre Post Graduate Institute of Medical Education & Research
state: Punjab
city: Kanpur
country: India
facility: Dr. J L Rohatgi Memorial Eye Hospital
state: Uttar Pradesh
city: Lucknow
country: India
facility: King George's Medical University
state: Uttar Pradesh
city: Varanasi
country: India
facility: R.K.Netralaya Eye Hospital (P) Ltd.
state: Uttar Pradesh
city: Kolkata
country: India
facility: Regional Institute of Ophthalmology
state: West Bengal
city: New Delhi
country: India
facility: Dr. Shroff's Charity Eye Hospital
city: New Delhi
country: India
facility: Sir Ganga Ram Hosptial
city: New Delhi
country: India
facility: Aakash Healthcare Super Specialty Hospital
Study officials:
References: