Neovascular Age-related Macular DegenerationPhase 3NCT04690556
Study to Compare Efficacy, Safety, and Immunogenicity of LUBT010 (Proposed Ranibizumab Biosimilar) and Lucentis® in Patients With Neovascular AMD
A Phase 3 study testing LUBT010 (proposed ranibizumab biosimilar) and Lucentis (ranibizumab) in people with Neovascular Age-related Macular Degeneration, run by Lupin Ltd. at 78 sites in 7 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular Age-related Macular Degeneration
- What is being tested?
- LUBT010 (proposed ranibizumab biosimilar) and Lucentis (ranibizumab)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 78 sitesin 7 countries
- Study dates
- 14 Sep 2020to 31 May 2024
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- Other In-/Exclusion criteria may apply
Trial locations and contacts
78 sites in 7 countries.
78 sites in 7 countries
India40 sites
Advance Retina Care
Ahmedabad, Gujarat, 380005
Sadguru Netra Chikitsalaya
Ahmedabad, Gujarat, 380005
Netralaya - Super Speciality Eye Hospital
Ahmedabad, Gujarat, 380006
Rising Retina Clinic
Ahmedabad, Gujarat, 380015
Government Eye Hospital M & J Institute of Ophthalmology
Ahmedabad, Gujarat, 380016
M & J Western Regional Institute of Ophthalmology
Ahmedabad, Gujarat, 380016
P N Desai Eye Hospital
Ahmedabad, Gujarat, 380052
Deshmukh Eye Hospital
Amravati, Maharashtra, 444601
Sri Guru Ram Das Institute of Medical Sciences & Research
Amritsar, Punjab, 143501
Kamalnayan Bajaj Hospital
Aurangabad, Maharashtra, 431010
Nethra Eye Hospital
Bangalore, Karnataka, 560094
Advanced Eye Centre Post Graduate Institute of Medical Education & Research
Chandigarh, Punjab, 160012
Kanoria Hospital and Research Center
Gandhinagar, Gujarat, 382428
The Eye Care Center
Guwahati, Assam, 781003
Dr. J L Rohatgi Memorial Eye Hospital
Kanpur, Uttar Pradesh, 208005
Regional Institute of Ophthalmology
Kolkata, West Bengal, 700073
King George's Medical University
Lucknow, Uttar Pradesh, 226003
Sam Eye Hospital
Lucknow, Uttar Pradesh, Sam Eye Hospital
Aditya Jyot Eye Hospital Pvt. Ltd.
Mumbai, Maharashtra, 400031
Shroff Eye Hospital & Vision Research Centre
Mumbai, Maharashtra, 400050
Kenia Eye Hospital
Mumbai, Maharashtra, 400054
Anideep Eye Hospital
Mumbai, Maharashtra, 400056
Topiwala National Medical College & B. Y. L. Nair Charitable Hospital
Mumbai, Maharashtra, 400056
Mysore Medical College and Research Institute
Mysore, Karnataka, 570001
JSS Hospital
Mysore, Karnataka, 570004
Ambade Eye Hospital
Nagpur, Maharashtra, 440017
Dhadiwal Hospital in Coalition with Shreeji Healthcare
Nashik, Maharashtra, 422002
Dr. Shroff's Charity Eye Hospital
New Delhi, 110002
Sir Ganga Ram Hosptial
New Delhi, 110060
Aakash Healthcare Super Specialty Hospital
New Delhi, 110075
Vijay Vallabh Hospital and Medical Research Center
Pālghar, Maharashtra, 401303
Drishtipunj Eye Hospital Pvt Ltd
Patna, Bihar, 801503
Dr. D. Y. Patil Medical College
Pune, Maharashtra, 411018
Insight Institute of Ophthalmology
Pune, Maharashtra, 411039
Kashyap Memorial Eye Hospital Pvt. Ltd.
Ranchi, Jharkhand, 834001
Shivam Retina Clinic and Eye Hospital
Surat, Gujarat, 395001
Kiran Hospital Multi Super Speciality Hospital & Research Centre
Surat, Gujarat, 395004
Dr.Agarwal's Eye Hospital
Tirunelveli, Tamil Nadu, 627003
Regional Institute of Opthalmology
Trivandrum, Kerala, 695035
R.K.Netralaya Eye Hospital (P) Ltd.
Varanasi, Uttar Pradesh, 221010
Bulgaria10 sites
Medical Center Oxycom EOOD
Burgas, 8000
Eye medical center - Visus
Gorna Oryahovitsa, 5100
University First MHAT-Sofia, St. Joan Krastitel EAD
Sofia, 1142
MC Ophta-Nevro
Sofia, 1172
Specialized Eye Hospital Pentagram
Sofia, 1319
DCC Alexandrovska, EOOD
Sofia, 1431
Military Medical Academy - MHAT
Sofia, 1606
Specialized Hospital for Active Treatment of Ophthalmologic Diseases Zora, OOD
Sofia, 1784
MHAT Trakia, EOOD
Stara Zagora, 6000
Medical Center Vereya EOOD
Stara Zagora, 6008
Poland8 sites
Szpital Świętego Łukasza S. A.
Bielsko-Biala, 43309
Specjalistyczny Osrodek Okulistyczny Oculomedica
Bydgoszcz, 85-157
Prywatna Klinika Okulistyczna OFTALMIKA
Bydgoszcz, 85-631
Provisus Badania Kliniczne Sp. z o.o.
Częstochowa, 42-209
Clinical Medical Research Sp. z o.o.
Katowice, 40-156
Gabinet Okulistyczny prof. Edward Wylegala
Katowice, 40-594
ETG Lodz
Lodz, 90-302
CaminoMed - Specjalistyczne Gabinety Lekarskie
Tarnowskie Góry, 42-600
Slovakia8 sites
Fakultna nemocnica s poliklinikou F.D. Roosevelta
Banská Bystrica, 97517
Nemocnica svateho Michala
Bratislava, 81108
Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
Bratislava, 82601
Fakultna nemocnica s poliklinikou Nove Zamky
Nové Zámky, 94001
Nemocnica Poprad a.s.
Poprad, 05801
Nemocnica s poliklinikou Trebisov a.s.
Trebišov, 07501
Fakultna nemocnica Trencin
Trenčín, 91101
Fakultna nemocnica s poliklinikou Zilina
Žilina, 01001
United States6 sites
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211
Bruce A. Segal, MD, PA
Delray Beach, Florida, 33484
Cumberland Valley Retina Consultants, P.C.
Hagerstown, Maryland, 21740
Valley Retina Institute
McAllen, Texas, 78503
UPMC Eye Center - Eye and Ear Institute
Pittsburgh, Pennsylvania, 15213
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701
Russia5 sites
LLC HI Optic-Center
Chelyabinsk, 454007
RSHI State Novosibirsk Regional Clinical Hospital
Novosibirsk, 630087
BHI of Omsk region Clinical Ophthalmology Hospital n.a V.P. Vykhodtsev
Omsk, 644024
Standard Clinic Penza LLC
Penza, 440026
LLC X7 Clinical research
Saint Petersburg, 194156
Hungary1 site
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Győr, 9024
About this study
Official title: 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
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).
Read the 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.
- Being tested
- LUBT010 (proposed ranibizumab biosimilar), Lucentis (ranibizumab)
- Keywords
- Neovascular age-related macular degeneration, Ranibizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LUBT010 (proposed ranibizumab biosimilar)Drug
LUBT010 (proposed ranibizumab biosimilar) 0.5 mg via intravitreal injection once monthly
Lucentis (ranibizumab)Drug
Lucentis® 0.5 mg via intravitreal injection once monthly
| Study group | Role | What they receive |
|---|---|---|
| Drug: LUBT010 (proposed ranibizumab biosimilar) | Experimental | Not described Receives: Drug: LUBT010 (proposed ranibizumab biosimilar) |
| Drug: Lucentis (ranibizumab) | Active comparator | Not described Receives: Drug: Lucentis (ranibizumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and 12 Months
Secondary outcomes (3)
Mean Change in BCVA From Baseline in the Study Eye at the End of 3 Months
ETDRS charts were used for visual acuity measurement summarized descriptively by treatment arm and time point
Measured: Baseline and 3 Months
Mean Change in BCVA From Baseline in the Study Eye at the End of 6 Months
ETDRS charts were used for visual acuity measurement summarized descriptively by treatment arm and time point
Measured: Baseline and 6 Months
Mean Change in BCVA From Baseline in the Study Eye at the End of 9 Months
ETDRS charts were used for visual acuity measurement summarized descriptively by treatment arm and time point
Measured: Baseline and 9 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start14 Sep 2020
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neovascular Age-related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lupin Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04690556
- Sponsor's protocol ID
- LRP/LUBT010/2016/008
- Other IDs
- 2017-004409-42, 2017
- Status last verified
- Jan 2026
- First submitted
- 23 Nov 2020
- Last updated
- 29 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make Individual Participant Data (IPD) available.