Neovascular Age-related Macular Degeneration
Conditions
Keywords
Neovascular age-related macular degeneration, Ranibizumab
Brief 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).
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.
Interventions
DRUGLUBT010 (proposed ranibizumab biosimilar)
LUBT010 (proposed ranibizumab biosimilar) 0.5 mg via intravitreal injection once monthly
Lucentis® 0.5 mg via intravitreal injection once monthly
Sponsors
Lupin Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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-/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in BCVA From Baseline in the Study Eye at the End of 12 Months | Baseline and 12 Months | Early treatment diabetic retinopathy study (ETDRS) charts were used for visual acuity measurement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in BCVA From Baseline in the Study Eye at the End of 3 Months | Baseline and 3 Months | ETDRS charts were used for visual acuity measurement summarized descriptively by treatment arm and time point |
| Mean Change in BCVA From Baseline in the Study Eye at the End of 6 Months | Baseline and 6 Months | ETDRS charts were used for visual acuity measurement summarized descriptively by treatment arm and time point |
| Mean Change in BCVA From Baseline in the Study Eye at the End of 9 Months | Baseline and 9 Months | ETDRS charts were used for visual acuity measurement summarized descriptively by treatment arm and time point |
Countries
Bulgaria, Hungary, India, Poland, Russia, Slovakia, United States
Participant flow
Recruitment details
\[Not Specified\]
Pre-assignment details
\[Not Specified\]
Participants by arm
| Arm | Count |
|---|---|
| LUBT010 (Proposed Ranibizumab Biosimilar) 0.5 mg via intravitreal injection once monthly | 299 |
| Lucentis (Ranibizumab) 0.5 mg via intravitreal injection once monthly | 301 |
| Total | 600 |
Baseline characteristics
| Characteristic | Lucentis (Ranibizumab) | Total | LUBT010 (Proposed Ranibizumab Biosimilar) |
|---|---|---|---|
| Age, Continuous | 73.5 years STANDARD_DEVIATION 7.9 | 73.3 years STANDARD_DEVIATION 8.33 | 73.2 years STANDARD_DEVIATION 8.75 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 147 Participants | 305 Participants | 158 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 153 Participants | 294 Participants | 141 Participants |
| Sex: Female, Male Female | 146 Participants | 297 Participants | 151 Participants |
| Sex: Female, Male Male | 155 Participants | 303 Participants | 148 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 299 | 4 / 301 |
| other Total, other adverse events | 21 / 299 | 26 / 301 |
| serious Total, serious adverse events | 26 / 299 | 23 / 301 |
Outcome results
Primary
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
Time frame: Baseline and 12 Months
Population: Full Analysis Set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| LUBT010 (Proposed Ranibizumab Biosimilar) | Mean Change in BCVA From Baseline in the Study Eye at the End of 12 Months | 11.17 Letters | Standard Error 0.689 |
| Lucentis (Ranibizumab) | Mean Change in BCVA From Baseline in the Study Eye at the End of 12 Months | 11.14 Letters | Standard Error 0.68 |
Comparison: LUBT010 (Proposed Ranibizumab Biosimilar) - Lucentis90% CI: [-1.52, 1.58]
Secondary
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
Time frame: Baseline and 3 Months
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LUBT010 (Proposed Ranibizumab Biosimilar) | Mean Change in BCVA From Baseline in the Study Eye at the End of 3 Months | 7.3 Letters | Standard Deviation 8.38 |
| Lucentis (Ranibizumab) | Mean Change in BCVA From Baseline in the Study Eye at the End of 3 Months | 6.6 Letters | Standard Deviation 7.97 |
Secondary
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
Time frame: Baseline and 6 Months
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LUBT010 (Proposed Ranibizumab Biosimilar) | Mean Change in BCVA From Baseline in the Study Eye at the End of 6 Months | 9.5 Letters | Standard Deviation 9.67 |
| Lucentis (Ranibizumab) | Mean Change in BCVA From Baseline in the Study Eye at the End of 6 Months | 8.7 Letters | Standard Deviation 10.35 |
Secondary
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
Time frame: Baseline and 9 Months
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LUBT010 (Proposed Ranibizumab Biosimilar) | Mean Change in BCVA From Baseline in the Study Eye at the End of 9 Months | 10.6 Letters | Standard Deviation 11.36 |
| Lucentis (Ranibizumab) | Mean Change in BCVA From Baseline in the Study Eye at the End of 9 Months | 10.4 Letters | Standard Deviation 10.62 |