Study to Compare Efficacy, Safety, and Immunogenicity of LUBT010 (Proposed Ranibizumab Biosimilar) and Lucentis® in Patients With Neovascular AMD

January 21, 2026 updated by: Lupin Ltd.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Burgas, Bulgaria, 8000
        • Medical Center Oxycom EOOD
      • Gorna Oryahovitsa, Bulgaria, 5100
        • Eye medical center - Visus
      • Sofia, Bulgaria, 1606
        • Military Medical Academy - MHAT
      • Sofia, Bulgaria, 1431
        • DCC Alexandrovska, EOOD
      • Sofia, Bulgaria, 1319
        • Specialized Eye Hospital Pentagram
      • Sofia, Bulgaria, 1142
        • University First MHAT-Sofia, St. Joan Krastitel EAD
      • Sofia, Bulgaria, 1172
        • MC Ophta-Nevro
      • Sofia, Bulgaria, 1784
        • Specialized Hospital for Active Treatment of Ophthalmologic Diseases Zora, OOD
      • Stara Zagora, Bulgaria, 6000
        • MHAT Trakia, EOOD
      • Stara Zagora, Bulgaria, 6008
        • Medical Center Vereya EOOD
  • Hungary
      • Győr, Hungary, 9024
        • Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
  • India
      • New Delhi, India, 110002
        • Dr. Shroff's Charity Eye Hospital
      • New Delhi, India, 110060
        • Sir Ganga Ram Hosptial
      • New Delhi, India, 110075
        • Aakash Healthcare Super Specialty Hospital
    • Assam
      • Guwahati, Assam, India, 781003
        • The Eye Care Center
    • Bihar
      • Patna, Bihar, India, 801503
        • Drishtipunj Eye Hospital Pvt Ltd
    • Gujarat
      • Ahmedabad, Gujarat, India, 380015
        • Rising Retina Clinic
      • Ahmedabad, Gujarat, India, 380016
        • M & J Western Regional Institute of Ophthalmology
      • Ahmedabad, Gujarat, India, 380016
        • Government Eye Hospital M & J Institute of Ophthalmology
      • Ahmedabad, Gujarat, India, 380005
        • Advance Retina Care
      • Ahmedabad, Gujarat, India, 380005
        • Sadguru Netra Chikitsalaya
      • Ahmedabad, Gujarat, India, 380006
        • Netralaya - Super Speciality Eye Hospital
      • Ahmedabad, Gujarat, India, 380052
        • P N Desai Eye Hospital
      • Gandhinagar, Gujarat, India, 382428
        • Kanoria Hospital and Research Center
      • Surat, Gujarat, India, 395001
        • Shivam Retina Clinic and Eye Hospital
      • Surat, Gujarat, India, 395004
        • Kiran Hospital Multi Super Speciality Hospital & Research Centre
    • Jharkhand
      • Ranchi, Jharkhand, India, 834001
        • Kashyap Memorial Eye Hospital Pvt. Ltd.
    • Karnataka
      • Bangalore, Karnataka, India, 560094
        • Nethra Eye Hospital
      • Mysore, Karnataka, India, 570001
        • Mysore Medical College and Research Institute
      • Mysore, Karnataka, India, 570004
        • JSS Hospital
    • Kerala
      • Trivandrum, Kerala, India, 695035
        • Regional Institute of Opthalmology
    • Maharashtra
      • Amravati, Maharashtra, India, 444601
        • Deshmukh Eye Hospital
      • Aurangabad, Maharashtra, India, 431010
        • Kamalnayan Bajaj Hospital
      • Mumbai, Maharashtra, India, 400031
        • Aditya Jyot Eye Hospital Pvt. Ltd.
      • Mumbai, Maharashtra, India, 400050
        • Shroff Eye Hospital & Vision Research Centre
      • Mumbai, Maharashtra, India, 400056
        • Anideep Eye Hospital
      • Mumbai, Maharashtra, India, 400056
        • Topiwala National Medical College & B. Y. L. Nair Charitable Hospital
      • Mumbai, Maharashtra, India, 400054
        • Kenia Eye Hospital
      • Nagpur, Maharashtra, India, 440017
        • Ambade Eye Hospital
      • Nashik, Maharashtra, India, 422002
        • Dhadiwal Hospital in coalition with Shreeji Healthcare
      • Pune, Maharashtra, India, 411039
        • Insight Institute of Ophthalmology
      • Pune, Maharashtra, India, 411018
        • Dr. D. Y. Patil Medical College
      • Pālghar, Maharashtra, India, 401303
        • Vijay Vallabh Hospital and Medical Research Center
    • Punjab
      • Amritsar, Punjab, India, 143501
        • Sri Guru Ram Das Institute of Medical Sciences & Research
      • Chandigarh, Punjab, India, 160012
        • Advanced Eye Centre Post Graduate Institute of Medical Education & Research
    • Tamil Nadu
      • Tirunelveli, Tamil Nadu, India, 627003
        • Dr.Agarwal's Eye Hospital
    • Uttar Pradesh
      • Kanpur, Uttar Pradesh, India, 208005
        • Dr. J L Rohatgi Memorial Eye Hospital
      • Lucknow, Uttar Pradesh, India, 226003
        • King George's Medical University
      • Lucknow, Uttar Pradesh, India, Sam Eye Hospital
        • Sam Eye Hospital
      • Varanasi, Uttar Pradesh, India, 221010
        • R.K.Netralaya Eye Hospital (P) Ltd.
    • West Bengal
      • Kolkata, West Bengal, India, 700073
        • Regional Institute of Ophthalmology
  • Poland
      • Bielsko-Biala, Poland, 43309
        • Szpital Świętego Łukasza S. A.
      • Bydgoszcz, Poland, 85-631
        • Prywatna Klinika Okulistyczna OFTALMIKA
      • Bydgoszcz, Poland, 85-157
        • Specjalistyczny Osrodek Okulistyczny Oculomedica
      • Częstochowa, Poland, 42-209
        • Provisus Badania Kliniczne Sp. z o.o.
      • Katowice, Poland, 40-156
        • Clinical Medical Research Sp. z o.o.
      • Katowice, Poland, 40-594
        • Gabinet Okulistyczny Prof. Edward Wylegala
      • Lodz, Poland, 90-302
        • ETG Lodz
      • Tarnowskie Góry, Poland, 42-600
        • CaminoMed - Specjalistyczne Gabinety Lekarskie
  • Russia
      • Chelyabinsk, Russia, 454007
        • LLC HI Optic-Center
      • Novosibirsk, Russia, 630087
        • RSHI State Novosibirsk Regional Clinical Hospital
      • Omsk, Russia, 644024
        • BHI of Omsk region Clinical Ophthalmology Hospital n.a V.P. Vykhodtsev
      • Penza, Russia, 440026
        • Standard Clinic Penza LLC
      • Saint Petersburg, Russia, 194156
        • LLC X7 Clinical research
  • Slovakia
      • Banská Bystrica, Slovakia, 97517
        • Fakultna nemocnica s poliklinikou F.D. Roosevelta
      • Bratislava, Slovakia, 81108
        • Nemocnica svateho Michala
      • Bratislava, Slovakia, 82601
        • Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
      • Nové Zámky, Slovakia, 94001
        • Fakultna nemocnica s poliklinikou Nove Zamky
      • Poprad, Slovakia, 05801
        • Nemocnica Poprad a.s.
      • Trebišov, Slovakia, 07501
        • Nemocnica s poliklinikou Trebisov a.s.
      • Trenčín, Slovakia, 91101
        • Fakultna nemocnica Trencin
      • Žilina, Slovakia, 01001
        • Fakultna nemocnica s poliklinikou Zilina
  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • Retina-Vitreous Associates Medical Group
    • Florida
      • Delray Beach, Florida, United States, 33484
        • Bruce A. Segal, MD, PA
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Cumberland Valley Retina Consultants, P.C.
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Eye Center - Eye and Ear Institute
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Black Hills Regional Eye Institute
    • Texas
      • McAllen, Texas, United States, 78503
        • Valley Retina Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Ambulatory male or female participants with age ≥ 50 years at the time of screening
  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:

  1. Known hypersensitivity to ranibizumab or any of the components of study medication
  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

Other In-/Exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Drug: LUBT010 (proposed ranibizumab biosimilar)
Drug: LUBT010 (proposed ranibizumab biosimilar)
LUBT010 (proposed ranibizumab biosimilar) 0.5 mg via intravitreal injection once monthly
Active Comparator: Drug: Lucentis (ranibizumab)
Drug: Lucentis (ranibizumab)
Lucentis® 0.5 mg via intravitreal injection once monthly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change in BCVA From Baseline in the Study Eye at the End of 12 Months
Time Frame: Baseline and 12 Months
Early treatment diabetic retinopathy study (ETDRS) charts were used for visual acuity measurement
Baseline and 12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change in BCVA From Baseline in the Study Eye at the End of 3 Months
Time Frame: Baseline and 3 Months
ETDRS charts were used for visual acuity measurement summarized descriptively by treatment arm and time point
Baseline and 3 Months
Mean Change in BCVA From Baseline in the Study Eye at the End of 6 Months
Time Frame: Baseline and 6 Months
ETDRS charts were used for visual acuity measurement summarized descriptively by treatment arm and time point
Baseline and 6 Months
Mean Change in BCVA From Baseline in the Study Eye at the End of 9 Months
Time Frame: Baseline and 9 Months
ETDRS charts were used for visual acuity measurement summarized descriptively by treatment arm and time point
Baseline and 9 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lupin Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2020

Primary Completion (Actual)

May 31, 2024

Study Completion (Actual)

May 31, 2024

Study Registration Dates

First Submitted

November 23, 2020

First Submitted That Met QC Criteria

December 29, 2020

First Posted (Actual)

December 30, 2020

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 21, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LRP/LUBT010/2016/008
  • 2017-004409-42 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make Individual Participant Data (IPD) available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neovascular Age-related Macular Degeneration

Clinical Trials on Lucentis (ranibizumab)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe