A Phase III Randomised, Double-masked, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB15 (Proposed Aflibercept Biosimilar) and Eylea® in Subjects With Neovascular Age-related Macular Degeneration
Overview
- Phase
- Phase 3
- Intervention
- SB15 (Proposed aflibercept biosimilar)
- Conditions
- Neovascular Age-related Macular Degeneration
- Sponsor
- Samsung Bioepis Co., Ltd.
- Enrollment
- 449
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Best Corrected Visual Acuity (BCVA)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This is a randomised, double-masked, parallel group, multicentre study to evaluate the efficacy, safety, Pharmacokinetics (PK), and immunogenicity of SB15 compared to Eylea® in subjects with neovascular AMD.
Detailed Description
Subjects will be randomised in a 1:1 ratio to receive either SB15 or Eylea® (administered via intravitreal \[IVT\] injection 2 mg \[0.05 mL\] every 4 weeks for the first 3 months (i.e., at Weeks 0, 4, and 8), followed by 2 mg \[0.05 mL\] once every 8 weeks). At Week 32, subjects in Eylea® treatment group will be randomised again in a 1:1 ratio to either continue on Eylea® treatment or be transitioned to SB15 treatment. In the 8-week treatment cycle, IPs (SB15 or Eylea®) will be administered up to Week 48, and the last assessment will be done at Week 56, corresponding to the end of follow-up for all subjects.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 50 years at Screening
- •Treatment naïve, \*active subfoveal choroidal neovascularisation (CNV) lesion secondary to AMD in the study eye
- •The area of CNV must occupy at least 50% of total lesion in the study eye
- •Total lesion area ≤ 9.0 Disc Areas (DA) in size (including blood, scars, and neovascularisation) in the study eye
- •BCVA of 20/40 to 20/200 (letter score of 73 to 34, inclusive) using ETDRS charts or 2702 series Number charts in the study eye at Screening and at Week 0 (Day 1) prior to randomisation
- •Non-childbearing potential female, OR childbearing potential female subjects or male subjects with their (respectively male or female) partners who agree to use at least two forms of appropriate contraception method that can achieve a failure rate of less than 1% per year from Screening until 3 months after the last IVT injection of IP
- •Written informed consent form (ICF) must be obtained from the subject prior to any study related procedure
- •Willingness and ability to undertake all scheduled visits and assessments
Exclusion Criteria
- •Study eye: Sub- or intra-retinal haemorrhage that comprises more than 50% of the entire lesion or presence of blood with the size of 1 DA or more involving the centre of fovea
- •Study eye: Scar, fibrosis, or atrophy involving the centre of the fovea
- •Study eye: Presence of CNV due to other causes, such as ocular histoplasmosis, trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture, or pathologic myopia
- •Study eye: Presence of retinal pigment epithelial tears or rips involving the macula
- •Study eye: Presence of macular hole at any stage
- •Study eye: Any concurrent macular abnormality other than AMD which could affect central vision or the efficacy of IP
- •Study eye: Any concurrent ocular condition which, in the opinion of the Investigator, could either confound the interpretation of efficacy and safety of IP or require medical or surgical intervention during the study period
- •Either eye: History or clinical evidence of diabetic retinopathy (except for mild non-proliferative diabetic retinopathy) or diabetic macular oedema (DME)
- •Study eye: Current vitreous haemorrhage
- •Either eye: Any previous IVT anti-vascular endothelial growth factor (VEGF) treatment
Arms & Interventions
SB15 (Proposed aflibercept biosimilar)
Subjects randomized into SB15 group will receive SB15 2 mg (0.05 mL) via intravitreal injection every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) once every 8 weeks until Week 48.
Intervention: SB15 (Proposed aflibercept biosimilar)
Eylea (Aflibercept)
Subjects randomized into Eylea group will receive Eylea 2 mg (0.05 mL) via intravitreal injection every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) once every 8 weeks until Week 48. At Week 32, subjects in Eylea group will re-randomized into SB15 or Eylea group. After re-randomization, subjects transited to SB15 group will receive SB15 2 mg (0.05 mL) once every 8 weeks until Week 48 and subjects remaining in Eylea group will continue to receive Eylea 2 mg (0.05 mL) once every 8 weeks until Week 48.
Intervention: SB15 (Proposed aflibercept biosimilar)
Eylea (Aflibercept)
Subjects randomized into Eylea group will receive Eylea 2 mg (0.05 mL) via intravitreal injection every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) once every 8 weeks until Week 48. At Week 32, subjects in Eylea group will re-randomized into SB15 or Eylea group. After re-randomization, subjects transited to SB15 group will receive SB15 2 mg (0.05 mL) once every 8 weeks until Week 48 and subjects remaining in Eylea group will continue to receive Eylea 2 mg (0.05 mL) once every 8 weeks until Week 48.
Intervention: Eylea (Aflibercept)
Outcomes
Primary Outcomes
Change From Baseline in Best Corrected Visual Acuity (BCVA)
Time Frame: Baseline and Week 8
The VA was assessed using original series ETDRS charts or 2702 series number charts.