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

COMPLETEDPHASE3

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

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

NCT04690556•Lupin Ltd.

View on ClinicalTrials.gov

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

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (78)

Retina-Vitreous Associates Medical Group

Beverly Hills, California, United States

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

Key Dates

Start Date

September 14, 2020

Primary Completion Date

May 31, 2024

Completion Date

May 31, 2024

Last Updated

January 29, 2026

Enrollment

600

ACTUAL participants

Conditions

Neovascular Age-related Macular Degeneration

Interventions

LUBT010 (proposed ranibizumab biosimilar)

DRUG

Lucentis (ranibizumab)

DRUG

A Study of the Efficacy, Safety, and Pharmacokinetics (PK) of the Port Delivery System With Ranibizumab (PDS) in Chinese Participants With Neovascular Age-related Macular Degeneration (nAMD)

NCT05562947

Neovascular Age-related Macular DegenerationnAMD

View study

RECRUITINGPHASE3

Home OCT-Guided Treatment Versus Treat and Extend for the Management of Neovascular AMD

NCT05904028

Neovascular Age-related Macular Degeneration

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 29, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of the Efficacy, Safety, and Pharmacokinetics (PK) of the Port Delivery System With Ranibizumab (PDS) in Chinese Participants With Neovascular Age-related Macular Degeneration (nAMD)

Home OCT-Guided Treatment Versus Treat and Extend for the Management of Neovascular AMD

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