A phase III clinical study to compare SB15 and Eylea in patients with neovascular age-related macular degeneratio
- Conditions
- eovascular age-related macular degeneration
- Registration Number
- JPRN-jRCT2080225300
- Lead Sponsor
- Samsung Bioepis Co., Ltd.
- Brief Summary
Therapeutic equivalence was demonstrated between SB15 and Eylea based on change from baseline in BCVA at Week 8 in this study. Comparable efficacy between SB15 and Eylea was well maintained up to Week 56 in patients with neovascular AMD. Types and characteristics of adverse events in SB15 were comparable to and in line with the known safety profiles of reference aflibercept. Eylea+SB15 had similar efficacy and safety compared to the continuing groups (SB15+SB15, Eylea+Eylea) without treatment-emergent issues.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 21
1. Age >= 50 years at Screening
2. Treatment naive, active subfoveal choroidal neovascularisation (CNV) lesion secondary to AMD in the study eye
3. The area of CNV must occupy at least 50% of total lesion in the study eye
4. Total lesion area <= 9.0 Disc Areas (DA) in size (including blood, scars, and neovascularisation) in the study eye
5. 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
6. 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
7. Written informed consent form (ICF) must be obtained from the subject prior to any study related procedure
8. Willingness and ability to undertake all scheduled visits and assessments
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
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 (except for mild non-proliferative 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 (including prescribed herbal medication) to treat neovascular AMD within 30 days prior to randomisation. However, dietary supplements, vitamins, or minerals will be allowed.
14. Study eye: History of vitrectomy, scleral buckling (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 nonconsecutive days within 90 days prior to randomisation
17. Use of systemic corticosteroids for 30 or more consecutive days within 90 days prior to randomization (inhaled steroid is permitted).
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 at Screening.
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 (excluding dietary supplementary, vitamins, and minerals).
23. Subject having BCVA of worse than or equal to 20/200 in the fellow 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 (unless it occurred as a result of a YAG laser posterior capsulotomy in association with prior posterior chamber IOL implantation)
26. Either e
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Change from baseline in BCVA at Week 8
- Secondary Outcome Measures
Name Time Method