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.
- Diseases
- Macular degeneration
- 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
Sites (78)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical Center Oxycom EOOD Coordinator of this site? Confirm its status | Burgas | Bulgaria | Unknown status |
| Eye medical center - Visus Coordinator of this site? Confirm its status | Gorna Oryahovitsa | Bulgaria | Unknown status |
| DCC Alexandrovska EOOD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Unknown status |
| Specialized Eye Hospital Pentagram Coordinator of this site? Confirm its status | Sofia | Bulgaria | Unknown status |
| MC Ophta-Nevro Coordinator of this site? Confirm its status | Sofia | Bulgaria | Unknown status |
| Military Medical Academy MHAT Coordinator of this site? Confirm its status | Sofia | Bulgaria | Unknown status |
| University First MHAT-Sofia St. Joan Krastitel EAD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Unknown status |
| Specialized Hospital for Active Treatment of Ophthalmologic Diseases ?Zora?, OOD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Unknown status |
| MHAT Trakia, EOOD Coordinator of this site? Confirm its status | Stara Zagora | Bulgaria | Unknown status |
| Medical Center Vereya EOOD Coordinator of this site? Confirm its status | Stara Zagora | Bulgaria | Unknown status |
| Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz Coordinator of this site? Confirm its status | Győr | Hungary | Unknown status |
| Advance Retina Care Coordinator of this site? Confirm its status | Ahmedabad | India | Unknown status |
| P N Desai Eye Hospital Coordinator of this site? Confirm its status | Ahmedabad | India | Unknown status |
| Government Eye Hospital M & J Institute of Ophthalmology Coordinator of this site? Confirm its status | Ahmedabad | India | Unknown status |
| Rising Retina Clinic Coordinator of this site? Confirm its status | Ahmedabad | India | Unknown status |
| Netralaya - Super Speciality Eye Hospital Coordinator of this site? Confirm its status | Ahmedabad | India | Unknown status |
| Sadguru Netra Chikitsalaya Coordinator of this site? Confirm its status | Ahmedabad | India | Unknown status |
| M&J western regional institute of ophthalmology Coordinator of this site? Confirm its status | Ahmedabad | India | Unknown status |
| Deshmukh Eye Hospital Coordinator of this site? Confirm its status | Amravati | India | Unknown status |
| Sri Guru Ram Das Institute of Medical Sciences & Research Coordinator of this site? Confirm its status | Amritsar | India | Unknown status |
| Nethra Eye Hospital Coordinator of this site? Confirm its status | Bangalore | India | Unknown status |
| Advanced Eye Centre Post Graduate Institute of Medical Education & Research Coordinator of this site? Confirm its status | Chandigarh | India | Unknown status |
| Kamalnayan Bajaj Hospital Coordinator of this site? Confirm its status | Chhatrapati Sambhajinagar | India | Unknown status |
| Kanoria Hospital and Research Center Coordinator of this site? Confirm its status | Gandhinagar | India | Unknown status |
| The Eye Care Center Coordinator of this site? Confirm its status | Guwahati | India | Unknown status |
| Dr. J L Rohatgi Memorial Eye Hospital Coordinator of this site? Confirm its status | Kanpur | India | Unknown status |
| Regional institute of ophthalmology Coordinator of this site? Confirm its status | Kolkata | India | Unknown status |
| Sam Eye Hospital Coordinator of this site? Confirm its status | Lucknow | India | Unknown status |
| King George's Medical University Coordinator of this site? Confirm its status | Lucknow | India | Unknown status |
| Topiwala National Medical College & B. Y. L. Nair Charitable Hospital Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
| Kenia Eye Hospital Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
| Anideep Eye Hospital Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
| Shroff Eye Hospital & Vision Research Centre Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
| Aditya Jyot Eye Hospital Pvt. Ltd. Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
| Mysore Medical College and Research Institute Coordinator of this site? Confirm its status | Mysore | India | Unknown status |
| JSS Hospital Coordinator of this site? Confirm its status | Mysore | India | Unknown status |
| Ambade eye hospital Coordinator of this site? Confirm its status | Nagpur | India | Unknown status |
| Dhadiwal Hospital in coalition with Shreeji Healthcare Coordinator of this site? Confirm its status | Nashik | India | Unknown status |
| Aakash Healthcare Super Specialty Hospital Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
| Dr. Shroff's Charity Eye Hospital Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
| Sir Ganga Ram Hosptial Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
| Vijay Vallabh Hospital and Medical Research Center Coordinator of this site? Confirm its status | Pālghar | India | Unknown status |
| Drishtipunj Eye Hospital Pvt Ltd Coordinator of this site? Confirm its status | Patna | India | Unknown status |
| Insight Institute of Ophthalmology Coordinator of this site? Confirm its status | Pune | India | Unknown status |
| Dr. D. Y. Patil Medical College Coordinator of this site? Confirm its status | Pune | India | Unknown status |
| Kashyap Memorial Eye Hospital Pvt. Ltd. Coordinator of this site? Confirm its status | Ranchi | India | Unknown status |
| Kiran Hospital Multi Super Speciality Hospital & Research Centre Coordinator of this site? Confirm its status | Surat | India | Unknown status |
| Shivam Retina Clinic and Eye Hospital Coordinator of this site? Confirm its status | Surat | India | Unknown status |
| Dr.Agarwal's Eye Hospital Coordinator of this site? Confirm its status | Tirunelveli | India | Unknown status |
| Regional Institute of Opthalmology Coordinator of this site? Confirm its status | Trivandrum | India | Unknown status |
| R.K.Netralaya Eye Hospital (P) Ltd. Coordinator of this site? Confirm its status | Varanasi | India | Unknown status |
| Szpital Świętego Łukasza S. A. Coordinator of this site? Confirm its status | Bielsko-Biala | Poland | Unknown status |
| Prywatna Klinika Okulistyczna OFTALMIKA Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Unknown status |
| Specjalistyczny Osrodek Okulistyczny Oculomedica Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Unknown status |
| Provisus Badania Kliniczne Sp. z o.o. Coordinator of this site? Confirm its status | Częstochowa | Poland | Unknown status |
| Clinical Medical Research Sp. z o.o. Coordinator of this site? Confirm its status | Katowice | Poland | Unknown status |
| Gabinet Okulistyczny Prof Edward Wylegala Coordinator of this site? Confirm its status | Katowice | Poland | Unknown status |
| ETG Lodz Coordinator of this site? Confirm its status | Lodz | Poland | Unknown status |
| CaminoMed - Specjalistyczne Gabinety Lekarskie Coordinator of this site? Confirm its status | Tarnowskie Góry | Poland | Unknown status |
| LLC HI Optic-Center Coordinator of this site? Confirm its status | Chelyabinsk | Russia | Unknown status |
| RSHI State Novosibirsk Regional Clinical Hospital Coordinator of this site? Confirm its status | Novosibirsk | Russia | Unknown status |
| BHI of Omsk region Clinical Ophthalmology Hospital n.a V.P. Vykhodtsev Coordinator of this site? Confirm its status | Omsk | Russia | Unknown status |
| Standard Clinic Penza LLC Coordinator of this site? Confirm its status | Penza | Russia | Unknown status |
| LLC X7 Clinical research Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Fakultna nemocnica s poliklinikou F.D.Roosevelta Coordinator of this site? Confirm its status | Banská Bystrica | Slovakia | Unknown status |
| Univerzitná nemocnica Bratislava - Nemocnica Ružinov Coordinator of this site? Confirm its status | Bratislava | Slovakia | Unknown status |
| Nemocnica svateho Michala Coordinator of this site? Confirm its status | Bratislava | Slovakia | Unknown status |
| Fakultna nemocnica s poliklinikou Nove Zamky Coordinator of this site? Confirm its status | Nové Zámky | Slovakia | Unknown status |
| Nemocnica Poprad, a.s. Coordinator of this site? Confirm its status | Poprad | Slovakia | Unknown status |
| Nemocnica s poliklinikou Trebisov a.s. Coordinator of this site? Confirm its status | Trebišov | Slovakia | Unknown status |
| Fakultna nemocnica Trencin Coordinator of this site? Confirm its status | Trenčín | Slovakia | Unknown status |
| Fakultna nemocnica s poliklinikou Zilina Coordinator of this site? Confirm its status | Žilina | Slovakia | Unknown status |
| Retina-Vitreous Associates Medical Group Coordinator of this site? Confirm its status | Beverly Hills | United States | Unknown status |
| Bruce A. Segal, MD, PA Coordinator of this site? Confirm its status | Delray Beach | United States | Unknown status |
| Cumberland Valley Retina Consultants,P.C. Coordinator of this site? Confirm its status | Hagerstown | United States | Unknown status |
| Valley Retina Institute Coordinator of this site? Confirm its status | McAllen | United States | Unknown status |
| UPMC Eye Center, Eye and Ear Institute Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Black Hills Regional Eye Institute Coordinator of this site? Confirm its status | Rapid City | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.