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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
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
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Nethra Eye Hospital

    Bangalore, Karnataka, 560094

  • Advanced Eye Centre Post Graduate Institute of Medical Education & Research

    Chandigarh, Punjab, 160012

  • Kamalnayan Bajaj Hospital

    Chhatrapati Sambhajinagar, Maharashtra, 431010

  • 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

Other trials in India

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

Other trials in Bulgaria

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

Other trials in Poland

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

Other trials in Slovakia

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

Other trials in United States

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

Other trials in Russia

Hungary1 site

  • Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz

    Győr, 9024

Other trials in Hungary

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 groups in NCT04690556
Study groupRoleWhat they receive
Drug: LUBT010 (proposed ranibizumab biosimilar)ExperimentalNot described
Receives: Drug: LUBT010 (proposed ranibizumab biosimilar)
Drug: Lucentis (ranibizumab)Active comparatorNot described
Receives: Drug: Lucentis (ranibizumab)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline and 12 Months

Secondary outcomes (3)

  1. 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

  2. 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

  3. 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.

  1. First posted30 Dec 2020
  2. Study start14 Sep 2020
  3. Primary completion31 May 2024
  4. Study completion31 May 2024

Resources

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)
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
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.

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in India, Bulgaria, Poland, Slovakia, United States and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change in BCVA From Baseline in the Study Eye at the End of 12 Months (time frame: Baseline and 12 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04690556.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.

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