Neovascular age-related macular degeneration MedDRA version: 20.0 Level: PT Classification code 10071129 Term: Neovascular age-related macular degeneration System Organ Class: 10015919 - Eye disorders
Conditions
Sponsors
Samsung Bioepis Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 50 years at Screening 2. Treatment naïve, *active subfoveal choroidal neovascularisation (CNV) lesion secondary to AMD in the study eye * Active CNV indicates presence of leakage and intra- or sub-retinal fluid which should be confirmed by the central reading centre during Screening. 3. The area of CNV must occupy at least 50% of total lesion in the study eye (confirmed by the central reading centre during Screening) 4. Total lesion area = 9.0 Disc Areas (DA) in size (including blood, scars, and neovascularisation) in the study eye (confirmed by the central reading centre during Screening) 5. BCVA of 20/40 to 20/200 (letter score of 73 to 34, inclusive) using original series Early Treatment Diabetic Retinopathy Study (ETDRS) charts or 2702 series Number charts in the study eye at Screening and at Week 0 (Day 1) prior to randomisation 6. Non-childbearing potential female (e.g., permanently sterilized, postmenopausal [defined as 12 months with no menses without an alternative medical cause prior to Screening]), 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 (e.g., established use of oral, injected, intravaginal, transdermal, or implanted hormonal contraceptive, placement of an intrauterine device or intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner, physical barrier, sexual abstinence) from Screening until 3 months after the last IVT injection of IP 7. Written informed consent form (ICF) must be obtained from the subject prior to any study related procedure (if the subject is legal blindness or illiterate, an impartial witness should be present during the entire informed consent discussion) 8. Willingness and ability to undertake all scheduled visits and assessments Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 96 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 591
Exclusion criteria
Exclusion criteria: 1. 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 2. Study eye: Scar, fibrosis, or atrophy involving the centre of the fovea 3. 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 4. Study eye: Presence of retinal pigment epithelial tears or rips involving the macula 5. Study eye: Presence of macular hole at any stage 6. Study eye: Any concurrent macular abnormality other than AMD which could affect central vision or the efficacy of IP including but not limited to epiretinal membrane, vitreomacular traction, macular telangiectasia, retinal vascular abnormality, etc. 7. 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 8. Either eye: History or clinical evidence of diabetic retinopathy or diabetic macular oedema (DME) 9. Study eye: Current vitreous haemorrhage 10. Either eye: Any previous IVT anti-vascular endothelial growth factor (VEGF) treatment 11. Any previous systemic anti-VEGF treatment 12. Study eye: History of treatment involving macula such as macular laser photocoagulation, photodynamic therapy (PDT), transpupillary thermotherapy (TTT), radiation therapy, or any ocular treatment for neovascular AMD 13. Any systemic treatment or therapy to treat neovascular AMD within 30 days prior to randomisation, and such treatment or therapy will not be allowed during the study period. 14. Study eye: History of vitrectomy, scleral bucking (encircling), glaucoma filtration surgery, corneal transplantation, or pan-retinal photocoagulation 15. Study eye: Previous ocular (intraocular and peribulbar) corticosteroids injection/implant within 1 year prior to randomisation 16. Study eye: Topical ocular corticosteroids administered for = 30 consecutive days or for = 60 non-consecutive days within 90 days prior to randomisation 17. Use of systemic corticosteroids for 30 or more consecutive days within 90 days prior to randomisation. 18. Study eye: Any other intraocular surgery or periocular surgery within 90 days prior to randomisation, except for lid surgery, which may not have taken place within 30 days prior to randomisation. 19. Current use of medications known to be toxic to the lens, retina, or optic nerve, including at Screening and such medications will not be allowed during the study period. 20. Study eye: Previous radiation therapy near the region of the study eye 21. Previous participation in clinical studies with IP to treat neovascular AMD in either eye. 22. Previous participation in clinical studies with IP to treat disease other than neovascular AMD within 90 days prior to randomisation. 23. Subject with only one functional eye 24. Study eye: Spherical equivalent of the refractive error demonstrating more than 6 diopters of myopia. For subjects who have undergone previous refractive or cataract surgery in the study eye, the preoperative refractive error in the study eye cannot exceed 6 diopters of myopia. 25. Study eye: Aphakia or absence of the posterior capsule 26. Either eye: Active or suspected ocular and periocular infection at Screening or at randomisation 27. Either eye: Active intraocular inflammati
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to demonstrate the equivalence in efficacy of SB15 compared to Eylea® in subjects with neovascular age-related macular degeneration (AMD).;Secondary Objective: • To evaluate the safety of SB15 compared to Eylea® • To evaluate the systemic exposure of SB15 compared to Eylea® in subjects participating in pharmacokinetics (PK) evaluation • To evaluate the immunogenicity of SB15 compared to Eylea®;Primary end point(s): Change from baseline in BCVA at Week 8;Timepoint(s) of evaluation of this end point: At Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change from baseline in BCVA over time up to Week 32 and up to Week 56 • Proportion of subjects who lost fewer than 15 letters in BCVA compared to baseline at Week 32 and Week 56 (proportion of subjects who maintained BCVA) • Proportion of subjects who gained 15 letters or more in BCVA compared to baseline at Week 32 and Week 56 • Change from baseline in central subfield thickness (CST) and total retinal thickness (TRT) at Week 4, and over time up to Week 32 and up to Week 56 (based on assessment by the central reading centre) - CST measured from internal limiting membrane (ILM) to retinal pigment epithelium (RPE) in 1-mm central subfield - TRT measured from ILM to Bruch’s membrane (BM) in 1-mm central subfield • Proportion of subjects with intra- or sub-retinal fluid on optical coherence tomography (OCT) at Week 32 and Week 56 (based on assessment by the central reading centre) • Change from baseline in CNV area at Week 32 and Week 56 (based on assessment by the central reading centre) • Proportion of subjects with active CNV leakage at Week 32 and Week 56 (based on assessment by the central reading centre);Timepoint(s) of evaluation of this end point: Please refer to section E.5.2 | — |
Countries
China, Croatia, Czech Republic, Estonia, Hungary, Japan, Korea, Republic of, Latvia, Poland, Russian Federation, United States
Contacts
Public ContactInformation Desk
Samsung Bioepis Co., Ltd.
Outcome results
None listed