Study to Compare Efficacy and Safety of LUBT010 and Lucentis® in Patients With Neovascular AMD
- Conditions
- Neovascular Age-related Macular Degeneration
- Interventions
- Drug: LUBT010 (proposed ranibizumab biosimilar)
- Registration Number
- NCT04690556
- Lead Sponsor
- Lupin Ltd.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 600
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lucentis (ranibizumab) Lucentis (ranibizumab) Intravitreal injection LUBT010 (proposed ranibizumab biosimilar) LUBT010 (proposed ranibizumab biosimilar) Intravitreal injection
- Primary Outcome Measures
Name Time Method Mean change in BCVA from baseline in the study eye at the end of 12, months assessed with the ETDRS chart 12 months
- Secondary Outcome Measures
Name Time Method Mean change in BCVA from baseline in the study eye accessed with the ETDRS chart 3 months, 6 months and 9 months Physical & systemic examination Baseline to 12 months Number of patients with clinically significant physical \& systemic examination findings.
Proportion of patients with anti-drug antibodies 1, 3, 6, 9, and 12 months Adverse Events (AEs) Baseline to 12 months Number of patients with treatment-emergent adverse events
Vital Signs Baseline to 12 months Number of patients with clinically significant vital signs findings
ECGs Baseline to 12 months Number of patients with clinically significant ECG findings
Clinical Laboratory Tests Baseline to 12 months Number of patients with clinically significant laboratory test findings
Ophthalmic examination Baseline to 12 months Number of patients with clinically significant ophthalmic examination findings
Trial Locations
- Locations (26)
Mysore Medical College and Research Institute
🇮🇳Mysore, Karnataka, India
JSS Hospital
🇮🇳Mysore, Karnataka, India
Aakash Healthcare Super Specialty Hospital
🇮🇳New Delhi, India
Kamalnayan Bajaj Hospital
🇮🇳Aurangabad, Maharashtra, India
Aditya Jyot Eye Hospital Pvt. Ltd.
🇮🇳Mumbai, Maharashtra, India
Rising Retina Clinic
🇮🇳Ahmedabad, Gujarat, India
Advanced Eye Centre Post Graduate Institute of Medical Education & Research
🇮🇳Chandigarh, Punjab, India
The Eye Care Center
🇮🇳Guwahati, Assam, India
Insight Institute of Ophthalmology
🇮🇳Pune, Maharashtra, India
King George's Medical University
🇮🇳Lucknow, Uttar Pradesh, India
Nethra Eye Hospital
🇮🇳Bangalore, Karnataka, India
Government Eye Hospital M & J Institute of Ophthalmology
🇮🇳Ahmedabad, Gujarat, India
Dr. Shroff's Charity Eye Hospital
🇮🇳New Delhi, India
Sir Ganga Ram Hosptial
🇮🇳New Delhi, India
Kanoria Hospital and Research Center
🇮🇳Gandhinagar, Gujarat, India
Shivam Retina Clinic and Eye Hospital
🇮🇳Sūrat, Gujarat, India
Shroff Eye Hospital & Vision Research Centre
🇮🇳Mumbai, Maharashtra, India
Dhadiwal Hospital in Coalition with Shreeji Healthcare
🇮🇳Nashik, Maharashtra, India
Anideep Eye Hospital
🇮🇳Mumbai, Maharashtra, India
Kiran Hospital Multi Super Speciality Hospital & Research Centre
🇮🇳Sūrat, Gujarat, India
Kashyap Memorial Eye Hospital Pvt. Ltd.
🇮🇳Ranchi, Jharkhand, India
Topiwala National Medical College & B. Y. L. Nair Charitable Hospital
🇮🇳Mumbai, Maharashtra, India
Vijay Vallabh Hospital and Medical Research Center
🇮🇳Palghar, Maharashtra, India
Dr. J L Rohatgi Memorial Eye Hospital
🇮🇳Kanpur, Uttar Pradesh, India
R.K.Netralaya Eye Hospital (P) Ltd.
🇮🇳Varanasi, Uttar Pradesh, India
Regional Institute of Ophthalmology
🇮🇳Kolkata, West Bengal, India