Phase 3
N=600
Study to Compare Efficacy, Safety, and Immunogenicity of LUBT010 (Proposed Ranibizumab Biosimilar) and Lucentis® in Patients With Neovascular AMD
Neovascular Age-related Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT04690556 ↗Enrolled (actual)
600
Serious AEs
8.2%
Results posted
Jan 2026
Primary outcome: Primary: Mean Change in BCVA From Baseline in the Study Eye at the End of 12 Months — 11.17; 11.14 Letters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- LUBT010 (proposed ranibizumab biosimilar) (Drug); Lucentis (ranibizumab) (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Lupin Ltd.
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in BCVA From Baseline in the Study Eye at the End of 12 Months |
11.17; 11.14 | — |
| SECONDARY Mean Change in BCVA From Baseline in the Study Eye at the End of 3 Months |
7.3; 6.6 | — |
| SECONDARY Mean Change in BCVA From Baseline in the Study Eye at the End of 6 Months |
9.5; 8.7 | — |
| SECONDARY Mean Change in BCVA From Baseline in the Study Eye at the End of 9 Months |
10.6; 10.4 | — |
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).
Eligibility Criteria
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-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
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
Data sourced from ClinicalTrials.gov (NCT04690556). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.