Study to Compare Efficacy, Safety, and Immunogenicity of LUBT010 (Proposed Ranibizumab Biosimilar) and Lucentis® in Patients With Neovascular AMD
NCT ID: NCT04690556
Last Updated: 2026-01-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
600 participants
INTERVENTIONAL
2020-09-14
2024-05-31
Brief Summary
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Detailed Description
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Eligible patients will be randomly assigned in 1:1 ratio to receive once monthly intravitreal injection of LUBT010 or Lucentis® for 12 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Drug: LUBT010 (proposed ranibizumab biosimilar)
LUBT010 (proposed ranibizumab biosimilar)
LUBT010 (proposed ranibizumab biosimilar) 0.5 mg via intravitreal injection once monthly
Drug: Lucentis (ranibizumab)
Lucentis (ranibizumab)
Lucentis® 0.5 mg via intravitreal injection once monthly
Interventions
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LUBT010 (proposed ranibizumab biosimilar)
LUBT010 (proposed ranibizumab biosimilar) 0.5 mg via intravitreal injection once monthly
Lucentis (ranibizumab)
Lucentis® 0.5 mg via intravitreal injection once monthly
Eligibility Criteria
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Inclusion Criteria
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
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
50 Years
ALL
No
Sponsors
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Lupin Ltd.
INDUSTRY
Responsible Party
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Locations
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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
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
P N Desai Eye Hospital
Ahmedabad, Gujarat, India
Kanoria Hospital and Research Center
Gandhinagar, Gujarat, India
Shivam Retina Clinic and Eye Hospital
Surat, Gujarat, India
Kiran Hospital Multi Super Speciality Hospital & Research Centre
Surat, Gujarat, India
Kashyap Memorial Eye Hospital Pvt. Ltd.
Ranchi, Jharkhand, India
Nethra Eye Hospital
Bangalore, Karnataka, India
Mysore Medical College and Research Institute
Mysore, Karnataka, India
JSS Hospital
Mysore, Karnataka, India
Regional Institute of Opthalmology
Trivandrum, Kerala, India
Deshmukh Eye Hospital
Amravati, Maharashtra, India
Kamalnayan Bajaj Hospital
Aurangabad, Maharashtra, India
Aditya Jyot Eye Hospital Pvt. Ltd.
Mumbai, Maharashtra, India
Shroff Eye Hospital & Vision Research Centre
Mumbai, Maharashtra, India
Kenia Eye Hospital
Mumbai, Maharashtra, India
Anideep Eye Hospital
Mumbai, Maharashtra, India
Topiwala National Medical College & B. Y. L. Nair Charitable Hospital
Mumbai, Maharashtra, India
Ambade Eye Hospital
Nagpur, Maharashtra, India
Dhadiwal Hospital in Coalition with Shreeji Healthcare
Nashik, Maharashtra, India
Vijay Vallabh Hospital and Medical Research Center
Pālghar, Maharashtra, India
Dr. D. Y. Patil Medical College
Pune, Maharashtra, India
Insight Institute of Ophthalmology
Pune, Maharashtra, India
Sri Guru Ram Das Institute of Medical Sciences & Research
Amritsar, Punjab, India
Advanced Eye Centre Post Graduate Institute of Medical Education & Research
Chandigarh, Punjab, India
Dr.Agarwal's Eye Hospital
Tirunelveli, Tamil Nadu, India
Dr. J L Rohatgi Memorial Eye Hospital
Kanpur, Uttar Pradesh, India
King George's Medical University
Lucknow, Uttar Pradesh, India
Sam Eye Hospital
Lucknow, Uttar Pradesh, India
R.K.Netralaya Eye Hospital (P) Ltd.
Varanasi, Uttar Pradesh, India
Regional Institute of Ophthalmology
Kolkata, West Bengal, India
Dr. Shroff's Charity Eye Hospital
New Delhi, , India
Sir Ganga Ram Hosptial
New Delhi, , India
Aakash Healthcare Super Specialty Hospital
New Delhi, , India
Szpital Świętego Łukasza S. A.
Bielsko-Biala, , Poland
Specjalistyczny Osrodek Okulistyczny Oculomedica
Bydgoszcz, , Poland
Prywatna Klinika Okulistyczna OFTALMIKA
Bydgoszcz, , Poland
Provisus Badania Kliniczne Sp. z o.o.
Częstochowa, , Poland
Clinical Medical Research Sp. z o.o.
Katowice, , Poland
Gabinet Okulistyczny prof. Edward Wylegala
Katowice, , Poland
ETG Lodz
Lodz, , Poland
CaminoMed - Specjalistyczne Gabinety Lekarskie
Tarnowskie Góry, , Poland
LLC HI Optic-Center
Chelyabinsk, , Russia
RSHI State Novosibirsk Regional Clinical Hospital
Novosibirsk, , Russia
BHI of Omsk region Clinical Ophthalmology Hospital n.a V.P. Vykhodtsev
Omsk, , Russia
Standard Clinic Penza LLC
Penza, , Russia
LLC X7 Clinical research
Saint Petersburg, , Russia
Fakultna nemocnica s poliklinikou F.D. Roosevelta
Banská Bystrica, , Slovakia
Nemocnica svateho Michala
Bratislava, , Slovakia
Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
Bratislava, , Slovakia
Fakultna nemocnica s poliklinikou Nove Zamky
Nové Zámky, , Slovakia
Nemocnica Poprad a.s.
Poprad, , Slovakia
Nemocnica s poliklinikou Trebisov a.s.
Trebišov, , Slovakia
Fakultna nemocnica Trencin
Trenčín, , Slovakia
Fakultna nemocnica s poliklinikou Zilina
Žilina, , Slovakia
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2017-004409-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
LRP/LUBT010/2016/008
Identifier Type: -
Identifier Source: org_study_id
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