Study to Compare Efficacy and Safety of LUBT010 and Lucentis® in Patients With Neovascular AMD
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ClinicalTrials.gov Identifier: NCT04690556 |
Recruitment Status :
Recruiting
First Posted : December 30, 2020
Last Update Posted : March 5, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Neovascular Age-related Macular Degeneration | Drug: Lucentis (ranibizumab) Drug: LUBT010 (proposed ranibizumab biosimilar) | Phase 3 |
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 (Clinical Trial) |
Estimated Enrollment : | 600 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | September 14, 2020 |
Estimated Primary Completion Date : | October 2022 |
Estimated Study Completion Date : | October 2022 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Lucentis (ranibizumab)
Intravitreal injection
|
Drug: Lucentis (ranibizumab)
Lucentis® 0.5 mg via intravitreal injection once monthly |
Experimental: LUBT010 (proposed ranibizumab biosimilar)
Intravitreal injection
|
Drug: LUBT010 (proposed ranibizumab biosimilar)
LUBT010 (proposed ranibizumab biosimilar) 0.5 mg via intravitreal injection once monthly |
- Mean change in BCVA from baseline in the study eye at the end of 12, months assessed with the ETDRS chart [ Time Frame: 12 months ]
- Mean change in BCVA from baseline in the study eye accessed with the ETDRS chart [ Time Frame: 3 months, 6 months and 9 months ]
- Proportion of patients with anti-drug antibodies [ Time Frame: 1, 3, 6, 9, and 12 months ]
- Adverse Events (AEs) [ Time Frame: Baseline to 12 months ]Number of patients with treatment-emergent adverse events
- Ophthalmic examination [ Time Frame: Baseline to 12 months ]Number of patients with clinically significant ophthalmic examination findings
- Physical & systemic examination [ Time Frame: Baseline to 12 months ]Number of patients with clinically significant physical & systemic examination findings.
- Vital Signs [ Time Frame: Baseline to 12 months ]Number of patients with clinically significant vital signs findings
- ECGs [ Time Frame: Baseline to 12 months ]Number of patients with clinically significant ECG findings
- Clinical Laboratory Tests [ Time Frame: Baseline to 12 months ]Number of patients with clinically significant laboratory test findings

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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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-VEGF naïve) active CNV lesions involving the foveal center secondary to AMD
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04690556
Contact: Dhananjay Bakhle, M.B.B.S, M.D | 91-20-66749000 ext 49054 | dhananjaybakhle@lupin.com |

Responsible Party: | Lupin Ltd. |
ClinicalTrials.gov Identifier: | NCT04690556 |
Other Study ID Numbers: |
LRP/LUBT010/2016/008 2017-004409-42 ( EudraCT Number ) |
First Posted: | December 30, 2020 Key Record Dates |
Last Update Posted: | March 5, 2021 |
Last Verified: | March 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | There is not a plan to make IPD available. |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Neovascular age-related macular degeneration, Ranibizumab |
Ranibizumab Macular Degeneration Wet Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases |
Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents |