Study to Compare Efficacy, Safety, and Immunogenicity of LUBT010 (Proposed Ranibizumab Biosimilar) and Lucentis® in Patients With Neovascular AMD

Completed · Phase 3

Conditions studied: Neovascular Age-related Macular Degeneration

In brief

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).

Key facts

Study ID

NCT04690556

Run by

Lupin Ltd.

People needed

600

Starts

2020-09-14

Expected to finish

2024-05-31

Last updated by the study team

2026-01-29

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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-vascular endothelial growth factor naïve) active choroidal neovascularization (CNV) lesions involving the foveal center secondary to AMD
• Best corrected visual acuity (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

You may not qualify if…

• 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

Where it is running

• Bruce A. Segal, MD, PA — Delray Beach, Florida, United States
• Cumberland Valley Retina Consultants, P.C. — Hagerstown, Maryland, United States
• UPMC Eye Center - Eye and Ear Institute — Pittsburgh, Pennsylvania, United States
• Black Hills Regional Eye Institute — Rapid City, South Dakota, United States
• Valley Retina Institute — McAllen, Texas, United States
• Medical Center Oxycom EOOD — Burgas, Bulgaria
• Eye medical center - Visus — Gorna Oryahovitsa, Bulgaria
• University First MHAT-Sofia, St. Joan Krastitel EAD — Sofia, Bulgaria
• MC Ophta-Nevro — Sofia, Bulgaria
• Specialized Eye Hospital Pentagram — Sofia, Bulgaria
• DCC Alexandrovska, EOOD — Sofia, Bulgaria
• Military Medical Academy - MHAT — Sofia, Bulgaria
• Specialized Hospital for Active Treatment of Ophthalmologic Diseases Zora, OOD — Sofia, Bulgaria
• MHAT Trakia, EOOD — Stara Zagora, Bulgaria
• Medical Center Vereya EOOD — Stara Zagora, Bulgaria
• Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz — Győr, Hungary
• The Eye Care Center — Guwahati, Assam, India
• Drishtipunj Eye Hospital Pvt Ltd — Patna, Bihar, India
• Advance Retina Care — Ahmedabad, Gujarat, India
• Sadguru Netra Chikitsalaya — Ahmedabad, Gujarat, India
• Netralaya - Super Speciality Eye Hospital — Ahmedabad, Gujarat, India
• Rising Retina Clinic — Ahmedabad, Gujarat, India
• Government Eye Hospital M & J Institute of Ophthalmology — Ahmedabad, Gujarat, India
• M & J Western Regional Institute of Ophthalmology — Ahmedabad, Gujarat, India
• Retina-Vitreous Associates Medical Group — Beverly Hills, California, United States

Full record on ClinicalTrials.gov

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