A Phase 3 Randomized, Double-masked, Multicenter Study to Compare the Efficacy and Safety of the Proposed Aflibercept FYB203 Biosimilar in Comparison to Eylea in Patients with Neovascular Age-Related Macular Degeneration (MAGELLAN-AMD)
Efficacy and Safety of the Aflibercept FYB203 Biosimilar in Comparison to Eylea in Patients with Neovascular Age-Related Macular Degeneration (MAGELLAN-AMD)
IQVIA Services Japan G.K. jRCT Inquiry Contact
IQVIA Services Japan G.K.
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+81-3-6859-9500
FYB203.Japan@iqvia.com
IQVIA Services Japan G.K. jRCT Inquiry Contact
IQVIA Services Japan G.K.
-
+81-3-6859-9500
FYB203.Japan@iqvia.com
completed
Aug. 03, 2020
400
Interventional
This study is a Phase 3 parallel-group, 1:1 randomized, active-controlled, double-masked, multicenter study to demonstrate clinical equivalence in terms of clinical efficacy, safety, and immunogenicity of FYB203 with EU-approved Eylea over 48 weeks of treatment in patients with subfoveal nAMD or wet AMD.
treatment purpose
3
1. Age >= 50 years at Screening.
2. Male or female:
[Male]:
- A male patient must agree to use contraception as defined in this protocol during the treatment period (48 weeks) and for at least 4 weeks after the last dose of study treatment.
[Female]:
- A female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
i) Not a woman of childbearing potential (WOCBP) OR ii) A WOCBP who agrees to follow the contraceptive guidance during the treatment period (48 weeks) and for at least 4 weeks after the last dose of study treatment
3. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
4. Willingness and ability to undertake all scheduled visits and assessments.
5. Newly diagnosed (within 6 months of Screening Visit), angiographically documented, treatment-naive choroidal neovascularization (CNV) lesion secondary to wet AMD
1.Employees of clinical study sites, individuals directly involved with the conduct of the study or immediate family members thereof, prisoners, and persons who are legally institutionalized.
2.Study eye requiring immediate treatment.
3.Any prior treatment with VEGF agent or any investigational products to treat AMD in either eye.
4.Uncontrolled ocular hypertension or glaucoma in the SE (defined as intraocular pressure [IOP] >= 30 mmHg, despite treatment with anti-glaucomatous medication).
5.Ocular disorders in the SE (i.e. retinal detachment, pre-retinal membrane of the macula or cataract with significant impact on VA) at the time of screening that may confound interpretation of study results and compromise VA.
6.Any concurrent intraocular condition in the SE (e.g. glaucoma, cataract, or diabetic retinopathy) that, in the opinion of the Investigator, would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of study results.
7.Use of other investigational drugs (excluding vitamins, minerals) within 30 days or 5 half lives from randomization, whichever is longer.
8.Any type of advanced, severe, or unstable disease, including any medical condition (controlled or uncontrolled) that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk.
9.Stroke or myocardial infarction within 6 months prior to randomization.
10.Known hypersensitivity to the IMP (aflibercept or any component of the aflibercept formulation) or to drugs of similar chemical class or to fluorescein or any other component of fluorescein formulation.
50age old over
100age old under
Both
Neovascular Age-Related Macular Degeneration
investigational material(s)
Generic name etc : FYB203
INN of investigational material : aflibercept
Therapeutic category code : 131 Agents for ophthalmic use
Dosage and Administration for Investigational material : 2 mg administered every 4 weeks for the first 3 months, followed by a 2 mg dose once every 8 weeks (2 months)
control material(s)
Generic name etc : Eylea
INN of investigational material : aflibercept
Therapeutic category code : 131 Agents for ophthalmic use
Dosage and Administration for Investigational material : 2 mg administered every 4 weeks for the first 3 months, followed by a 2 mg dose once every 8 weeks (2 months)
safety
efficacy
Changes from Baseline Visit in BCVA by ETDRS letters to Week 8
safety
efficacy
-Changes of retinal thickness
-Change of BCVA by ETDRS letters over the whole study
-Proportion of patients who gain or lose >= 5, 10, or 15 ETDRS letters from Baseline
-Percentage of patients with fluid-free macula at each Visit
-Systemic concentrations of aflibercept in a subgroup at selected sites
-Number of patients with ADAs over time
-Frequency of local and systemic AEs and SAEs
bioeq GmbH
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All Tohoku Clinical Trial Review and Audit Organization Institutional Review Board
