A Study to Compare SB15 (Proposed Aflibercept Biosimilar) to Eylea in Subjects With Neovascular A… (NCT04450329) | Clinical Trial Compass
CompletedPhase 3
A Study to Compare SB15 (Proposed Aflibercept Biosimilar) to Eylea in Subjects With Neovascular Age-related Macular Degeneration (AMD)
United States, Croatia449 participantsStarted 2020-06-23
Plain-language 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.
Who can participate
Age range50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Change From Baseline in Best Corrected Visual Acuity (BCVA)
. 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)