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

NCT04690556 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: LRP/LUBT010/2016/0082017-004409-42
• Study Type: interventional
• Target: 600
• Locations: 7 countries
• Sites: 78

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).

Conditions

Neovascular Age-related Macular Degeneration

Keywords

Neovascular age-related macular degeneration, Ranibizumab

Outcome Measures

Primary Outcomes (1)

• Mean Change in BCVA From Baseline in the Study Eye at the End of 12 Months

  Early treatment diabetic retinopathy study (ETDRS) charts were used for visual acuity measurement

  Baseline and 12 Months

Secondary Outcomes (3)

• Mean Change in BCVA From Baseline in the Study Eye at the End of 3 Months

  Baseline and 3 Months

• Mean Change in BCVA From Baseline in the Study Eye at the End of 6 Months

  Baseline and 6 Months

• Mean Change in BCVA From Baseline in the Study Eye at the End of 9 Months

  Baseline and 9 Months

Study Arms (2)

Drug: LUBT010 (proposed ranibizumab biosimilar)

EXPERIMENTAL

Drug: LUBT010 (proposed ranibizumab biosimilar)

Drug: Lucentis (ranibizumab)

ACTIVE COMPARATOR

Drug: Lucentis (ranibizumab)

Interventions

Lucentis (ranibizumab) DRUG

Lucentis® 0.5 mg via intravitreal injection once monthly

Drug: Lucentis (ranibizumab)

LUBT010 (proposed ranibizumab biosimilar) DRUG

LUBT010 (proposed ranibizumab biosimilar) 0.5 mg via intravitreal injection once monthly

Drug: LUBT010 (proposed ranibizumab biosimilar)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Lupin Ltd.: lead

Study Sites (78)

Retina-Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

Bruce A. Segal, MD, PA

Delray Beach, Florida, 33484, United States

Location

Cumberland Valley Retina Consultants, P.C.

Hagerstown, Maryland, 21740, United States

Location

UPMC Eye Center - Eye and Ear Institute

Pittsburgh, Pennsylvania, 15213, United States

Location

Black Hills Regional Eye Institute

Rapid City, South Dakota, 57701, United States

Location

Valley Retina Institute

McAllen, Texas, 78503, United States

Location

Medical Center Oxycom EOOD

Burgas, 8000, Bulgaria

Location

Eye medical center - Visus

Gorna Oryahovitsa, 5100, Bulgaria

Location

University First MHAT-Sofia, St. Joan Krastitel EAD

Sofia, 1142, Bulgaria

Location

MC Ophta-Nevro

Sofia, 1172, Bulgaria

Location

Specialized Eye Hospital Pentagram

Sofia, 1319, Bulgaria

Location

DCC Alexandrovska, EOOD

Sofia, 1431, Bulgaria

Location

Military Medical Academy - MHAT

Sofia, 1606, Bulgaria

Location

Specialized Hospital for Active Treatment of Ophthalmologic Diseases Zora, OOD

Sofia, 1784, Bulgaria

Location

MHAT Trakia, EOOD

Stara Zagora, 6000, Bulgaria

Location

Medical Center Vereya EOOD

Stara Zagora, 6008, Bulgaria

Location

Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz

Győr, 9024, Hungary

Location

The Eye Care Center

Guwahati, Assam, 781003, India

Location

Drishtipunj Eye Hospital Pvt Ltd

Patna, Bihar, 801503, India

Location

Advance Retina Care

Ahmedabad, Gujarat, 380005, India

Location

Sadguru Netra Chikitsalaya

Ahmedabad, Gujarat, 380005, India

Location

Netralaya - Super Speciality Eye Hospital

Ahmedabad, Gujarat, 380006, India

Location

Rising Retina Clinic

Ahmedabad, Gujarat, 380015, India

Location

Government Eye Hospital M & J Institute of Ophthalmology

Ahmedabad, Gujarat, 380016, India

Location

M & J Western Regional Institute of Ophthalmology

Ahmedabad, Gujarat, 380016, India

Location

P N Desai Eye Hospital

Ahmedabad, Gujarat, 380052, India

Location

Kanoria Hospital and Research Center

Gandhinagar, Gujarat, 382428, India

Location

Shivam Retina Clinic and Eye Hospital

Surat, Gujarat, 395001, India

Location

Kiran Hospital Multi Super Speciality Hospital & Research Centre

Surat, Gujarat, 395004, India

Location

Kashyap Memorial Eye Hospital Pvt. Ltd.

Ranchi, Jharkhand, 834001, India

Location

Nethra Eye Hospital

Bangalore, Karnataka, 560094, India

Location

Mysore Medical College and Research Institute

Mysore, Karnataka, 570001, India

Location

JSS Hospital

Mysore, Karnataka, 570004, India

Location

Regional Institute of Opthalmology

Trivandrum, Kerala, 695035, India

Location

Deshmukh Eye Hospital

Amravati, Maharashtra, 444601, India

Location

Kamalnayan Bajaj Hospital

Aurangabad, Maharashtra, 431010, India

Location

Aditya Jyot Eye Hospital Pvt. Ltd.

Mumbai, Maharashtra, 400031, India

Location

Shroff Eye Hospital & Vision Research Centre

Mumbai, Maharashtra, 400050, India

Location

Kenia Eye Hospital

Mumbai, Maharashtra, 400054, India

Location

Anideep Eye Hospital

Mumbai, Maharashtra, 400056, India

Location

Topiwala National Medical College & B. Y. L. Nair Charitable Hospital

Mumbai, Maharashtra, 400056, India

Location

Ambade Eye Hospital

Nagpur, Maharashtra, 440017, India

Location

Dhadiwal Hospital in Coalition with Shreeji Healthcare

Nashik, Maharashtra, 422002, India

Location

Vijay Vallabh Hospital and Medical Research Center

Pālghar, Maharashtra, 401303, India

Location

Dr. D. Y. Patil Medical College

Pune, Maharashtra, 411018, India

Location

Insight Institute of Ophthalmology

Pune, Maharashtra, 411039, India

Location

Sri Guru Ram Das Institute of Medical Sciences & Research

Amritsar, Punjab, 143501, India

Location

Advanced Eye Centre Post Graduate Institute of Medical Education & Research

Chandigarh, Punjab, 160012, India

Location

Dr.Agarwal's Eye Hospital

Tirunelveli, Tamil Nadu, 627003, India

Location

Dr. J L Rohatgi Memorial Eye Hospital

Kanpur, Uttar Pradesh, 208005, India

Location

King George's Medical University

Lucknow, Uttar Pradesh, 226003, India

Location

Sam Eye Hospital

Lucknow, Uttar Pradesh, Sam Eye Hospital, India

Location

R.K.Netralaya Eye Hospital (P) Ltd.

Varanasi, Uttar Pradesh, 221010, India

Location

Regional Institute of Ophthalmology

Kolkata, West Bengal, 700073, India

Location

Dr. Shroff's Charity Eye Hospital

New Delhi, 110002, India

Location

Sir Ganga Ram Hosptial

New Delhi, 110060, India

Location

Aakash Healthcare Super Specialty Hospital

New Delhi, 110075, India

Location

Szpital Świętego Łukasza S. A.

Bielsko-Biala, 43309, Poland

Location

Specjalistyczny Osrodek Okulistyczny Oculomedica

Bydgoszcz, 85-157, Poland

Location

Prywatna Klinika Okulistyczna OFTALMIKA

Bydgoszcz, 85-631, Poland

Location

Provisus Badania Kliniczne Sp. z o.o.

Częstochowa, 42-209, Poland

Location

Clinical Medical Research Sp. z o.o.

Katowice, 40-156, Poland

Location

Gabinet Okulistyczny prof. Edward Wylegala

Katowice, 40-594, Poland

Location

ETG Lodz

Lodz, 90-302, Poland

Location

CaminoMed - Specjalistyczne Gabinety Lekarskie

Tarnowskie Góry, 42-600, Poland

Location

LLC HI Optic-Center

Chelyabinsk, 454007, Russia

Location

RSHI State Novosibirsk Regional Clinical Hospital

Novosibirsk, 630087, Russia

Location

BHI of Omsk region Clinical Ophthalmology Hospital n.a V.P. Vykhodtsev

Omsk, 644024, Russia

Location

Standard Clinic Penza LLC

Penza, 440026, Russia

Location

LLC X7 Clinical research

Saint Petersburg, 194156, Russia

Location

Fakultna nemocnica s poliklinikou F.D. Roosevelta

Banská Bystrica, 97517, Slovakia

Location

Nemocnica svateho Michala

Bratislava, 81108, Slovakia

Location

Univerzitna nemocnica Bratislava, Nemocnica Ruzinov

Bratislava, 82601, Slovakia

Location

Fakultna nemocnica s poliklinikou Nove Zamky

Nové Zámky, 94001, Slovakia

Location

Nemocnica Poprad a.s.

Poprad, 05801, Slovakia

Location

Nemocnica s poliklinikou Trebisov a.s.

Trebišov, 07501, Slovakia

Location

Fakultna nemocnica Trencin

Trenčín, 91101, Slovakia

Location

Fakultna nemocnica s poliklinikou Zilina

Žilina, 01001, Slovakia

Location

MeSH Terms

Interventions

Ranibizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

\[Not Applicable\]

Results Point of Contact

• Title: Study Director: Lupin
• Organization: Lupin

chiragshah@lupin.com

020-66749100

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 30, 2020
• Study Start: September 14, 2020
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: January 29, 2026
• Results First Posted: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BU (10); HU (1); US (6); PL (8); IN (40); RU (5); SL (8)