Age-Related Macular Degeneration
Conditions
Brief summary
This is a randomised, double-masked, parallel group, multicentre study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of SB11 compared to Lucentis® in subjects with neovascular AMD.
Detailed description
Subjects will be randomised in a 1:1 ratio to receive either SB11 or Lucentis® (administered via intravitreal (ITV) 0.5 mg every 4 weeks). Investigational Products (IP) (SB11 or Lucentis®) will be administered up to Week 48, and the last assessment will be done at Week 52.
Interventions
DRUGSB11 (Proposed ranibizumab biosimilar)
SB11 (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every 4 weeks
Lucentis (ranibizumab) 0.5mg via intravitreal injection every 4 weeks
Sponsors
Samsung Bioepis Co., 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. Age ≥ 50 years 2. Newly diagnosed, active subfoveal choroid neovascularisation (CNV) lesion secondary to AMD in the study eye 3. BCVA of 20/40 to 20/200 in the study eye 4. Written informed consent form
Exclusion criteria
1. Any previous ITV anti-vascular endothelial growth factor (anti-VEGF) treatment to treat neovascular AMD in either eye 2. Presence of CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture or pathologic myopia 3. Any concurrent macular abnormality other than AMD in the study eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Best Corrected Visual Acuity (BCVA) | Baseline and Week 8 | The VA was assessed using original series ETDRS charts or 2702 series number charts. |
| Change From Baseline in Central Subfield Thickness (CST) | Baseline and Week 4 | The average retinal thickness in the central 1-mm area in the ETDRS grid (CST) was evaluated using (Optical Coherence Tomography) OCT |
Countries
Czechia, Germany, Hungary, India, Poland, Russia, South Korea, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SB11 (Proposed Ranibizumab Biosimilar) SB11 (Proposed ranibizumab biosimilar): SB11 (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every 4 weeks | 351 |
| Lucentis (Ranibizumab) Lucentis (ranibizumab): Lucentis (ranibizumab) 0.5mg via intravitreal injection every 4 weeks | 354 |
| Total | 705 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 7 | 6 |
| Overall Study | Death | 2 | 3 |
| Overall Study | IP non-compliance and other reasons | 12 | 3 |
| Overall Study | Lost to Follow-up | 3 | 3 |
| Overall Study | Protocol Violation | 4 | 3 |
| Overall Study | Withdrawal by Subject | 16 | 9 |
Baseline characteristics
| Characteristic | Lucentis (Ranibizumab) | Total | SB11 (Proposed Ranibizumab Biosimilar) |
|---|---|---|---|
| Age, Continuous | 73.8 years STANDARD_DEVIATION 8.92 | 74.1 years STANDARD_DEVIATION 8.48 | 74.4 years STANDARD_DEVIATION 8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 52 Participants | 103 Participants | 51 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) White | 300 Participants | 597 Participants | 297 Participants |
| Sex: Female, Male Female | 201 Participants | 403 Participants | 202 Participants |
| Sex: Female, Male Male | 153 Participants | 302 Participants | 149 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 350 | 0 / 354 |
| other Total, other adverse events | 111 / 350 | 126 / 354 |
| serious Total, serious adverse events | 52 / 350 | 52 / 354 |
Outcome results
Primary
Change From Baseline in Best Corrected Visual Acuity (BCVA)
The VA was assessed using original series ETDRS charts or 2702 series number charts.
Time frame: Baseline and Week 8
Population: Full Analysis Set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| SB11 (Proposed Ranibizumab Biosimilar) | Change From Baseline in Best Corrected Visual Acuity (BCVA) | 6.26 letters | Standard Error 0.51 |
| Lucentis (Ranibizumab) | Change From Baseline in Best Corrected Visual Acuity (BCVA) | 7.08 letters | Standard Error 0.51 |
Primary
Change From Baseline in Central Subfield Thickness (CST)
The average retinal thickness in the central 1-mm area in the ETDRS grid (CST) was evaluated using (Optical Coherence Tomography) OCT
Time frame: Baseline and Week 4
Population: Per-Protocol Set for CST
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| SB11 (Proposed Ranibizumab Biosimilar) | Change From Baseline in Central Subfield Thickness (CST) | -108.40 μm | Standard Error 4.65 |
| Lucentis (Ranibizumab) | Change From Baseline in Central Subfield Thickness (CST) | -100.05 μm | Standard Error 4.64 |