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NCT04690556CompletedPhase 3

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

Source: ClinicalTrials.gov · Last updated 29 Jan 2026

Brief summary (registry, in English)

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).

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
600 (actual)
First submitted
23 Nov 2020
Start date
14 Sept 2020
Primary completion date
31 May 2024
Lead sponsor
Lupin Ltd.
NCT number
NCT04690556
EudraCT number
2017-004409-42

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 600
  • From 14 Sept 2020 to the primary completion date, 31 May 2024
  • 78 sites in 7 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Known hypersensitivity to ranibizumab or any of the components of study medication
  • Known history of allergy to fluorescein dye
  • Subretinal hemorrhage in the study eye that involves the center of the fovea

Other

  • Scar, fibrosis, or atrophy involving the center of the fovea in the study eye
  • Uncontrolled glaucoma
  • Use of prohibited treatments
    • Other In-/Exclusion criteria may apply

Who the study is looking for

  • 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

Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (78)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medical Center Oxycom EOOD
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BurgasBulgariaUnknown status
Eye medical center - Visus
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Gorna OryahovitsaBulgariaUnknown status
DCC Alexandrovska EOOD
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SofiaBulgariaUnknown status
Specialized Eye Hospital Pentagram
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SofiaBulgariaUnknown status
MC Ophta-Nevro
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SofiaBulgariaUnknown status
Military Medical Academy MHAT
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SofiaBulgariaUnknown status
University First MHAT-Sofia St. Joan Krastitel EAD
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SofiaBulgariaUnknown status
Specialized Hospital for Active Treatment of Ophthalmologic Diseases ?Zora?, OOD
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SofiaBulgariaUnknown status
MHAT Trakia, EOOD
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Stara ZagoraBulgariaUnknown status
Medical Center Vereya EOOD
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Stara ZagoraBulgariaUnknown status
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
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GyőrHungaryUnknown status
Advance Retina Care
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AhmedabadIndiaUnknown status
P N Desai Eye Hospital
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AhmedabadIndiaUnknown status
Government Eye Hospital M & J Institute of Ophthalmology
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AhmedabadIndiaUnknown status
Rising Retina Clinic
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AhmedabadIndiaUnknown status
Netralaya - Super Speciality Eye Hospital
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AhmedabadIndiaUnknown status
Sadguru Netra Chikitsalaya
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AhmedabadIndiaUnknown status
M&J western regional institute of ophthalmology
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AhmedabadIndiaUnknown status
Deshmukh Eye Hospital
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AmravatiIndiaUnknown status
Sri Guru Ram Das Institute of Medical Sciences & Research
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AmritsarIndiaUnknown status
Nethra Eye Hospital
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BangaloreIndiaUnknown status
Advanced Eye Centre Post Graduate Institute of Medical Education & Research
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ChandigarhIndiaUnknown status
Kamalnayan Bajaj Hospital
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Chhatrapati SambhajinagarIndiaUnknown status
Kanoria Hospital and Research Center
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GandhinagarIndiaUnknown status
The Eye Care Center
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GuwahatiIndiaUnknown status
Dr. J L Rohatgi Memorial Eye Hospital
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KanpurIndiaUnknown status
Regional institute of ophthalmology
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KolkataIndiaUnknown status
Sam Eye Hospital
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LucknowIndiaUnknown status
King George's Medical University
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LucknowIndiaUnknown status
Topiwala National Medical College & B. Y. L. Nair Charitable Hospital
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MumbaiIndiaUnknown status
Kenia Eye Hospital
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MumbaiIndiaUnknown status
Anideep Eye Hospital
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MumbaiIndiaUnknown status
Shroff Eye Hospital & Vision Research Centre
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MumbaiIndiaUnknown status
Aditya Jyot Eye Hospital Pvt. Ltd.
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MumbaiIndiaUnknown status
Mysore Medical College and Research Institute
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MysoreIndiaUnknown status
JSS Hospital
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MysoreIndiaUnknown status
Ambade eye hospital
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NagpurIndiaUnknown status
Dhadiwal Hospital in coalition with Shreeji Healthcare
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NashikIndiaUnknown status
Aakash Healthcare Super Specialty Hospital
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New DelhiIndiaUnknown status
Dr. Shroff's Charity Eye Hospital
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New DelhiIndiaUnknown status
Sir Ganga Ram Hosptial
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New DelhiIndiaUnknown status
Vijay Vallabh Hospital and Medical Research Center
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PālgharIndiaUnknown status
Drishtipunj Eye Hospital Pvt Ltd
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PatnaIndiaUnknown status
Insight Institute of Ophthalmology
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PuneIndiaUnknown status
Dr. D. Y. Patil Medical College
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PuneIndiaUnknown status
Kashyap Memorial Eye Hospital Pvt. Ltd.
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RanchiIndiaUnknown status
Kiran Hospital Multi Super Speciality Hospital & Research Centre
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SuratIndiaUnknown status
Shivam Retina Clinic and Eye Hospital
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SuratIndiaUnknown status
Dr.Agarwal's Eye Hospital
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TirunelveliIndiaUnknown status
Regional Institute of Opthalmology
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TrivandrumIndiaUnknown status
R.K.Netralaya Eye Hospital (P) Ltd.
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VaranasiIndiaUnknown status
Szpital Świętego Łukasza S. A.
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Bielsko-BialaPolandUnknown status
Prywatna Klinika Okulistyczna OFTALMIKA
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BydgoszczPolandUnknown status
Specjalistyczny Osrodek Okulistyczny Oculomedica
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BydgoszczPolandUnknown status
Provisus Badania Kliniczne Sp. z o.o.
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CzęstochowaPolandUnknown status
Clinical Medical Research Sp. z o.o.
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KatowicePolandUnknown status
Gabinet Okulistyczny Prof Edward Wylegala
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KatowicePolandUnknown status
ETG Lodz
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LodzPolandUnknown status
CaminoMed - Specjalistyczne Gabinety Lekarskie
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Tarnowskie GóryPolandUnknown status
LLC HI Optic-Center
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ChelyabinskRussiaUnknown status
RSHI State Novosibirsk Regional Clinical Hospital
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NovosibirskRussiaUnknown status
BHI of Omsk region Clinical Ophthalmology Hospital n.a V.P. Vykhodtsev
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OmskRussiaUnknown status
Standard Clinic Penza LLC
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PenzaRussiaUnknown status
LLC X7 Clinical research
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Saint PetersburgRussiaUnknown status
Fakultna nemocnica s poliklinikou F.D.Roosevelta
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Banská BystricaSlovakiaUnknown status
Univerzitná nemocnica Bratislava - Nemocnica Ružinov
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BratislavaSlovakiaUnknown status
Nemocnica svateho Michala
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BratislavaSlovakiaUnknown status
Fakultna nemocnica s poliklinikou Nove Zamky
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Nové ZámkySlovakiaUnknown status
Nemocnica Poprad, a.s.
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PopradSlovakiaUnknown status
Nemocnica s poliklinikou Trebisov a.s.
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TrebišovSlovakiaUnknown status
Fakultna nemocnica Trencin
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TrenčínSlovakiaUnknown status
Fakultna nemocnica s poliklinikou Zilina
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ŽilinaSlovakiaUnknown status
Retina-Vitreous Associates Medical Group
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Beverly HillsUnited StatesUnknown status
Bruce A. Segal, MD, PA
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Delray BeachUnited StatesUnknown status
Cumberland Valley Retina Consultants,P.C.
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HagerstownUnited StatesUnknown status
Valley Retina Institute
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McAllenUnited StatesUnknown status
UPMC Eye Center, Eye and Ear Institute
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PittsburghUnited StatesUnknown status
Black Hills Regional Eye Institute
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Rapid CityUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.