Efficacy and Safety of the Aflibercept FYB203 Biosimilar in Comparison to Eylea® in Patients With Neovascular Age-Related Macular Degeneration

Study Overview
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Brief Summary
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This is a randomized, double-masked, multicenter study to evaluate the efficacy and safety of FYB203 compared to Eylea® in patients with neovascular age related macular degeneration.

Official Title
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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

Conditions
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Neovascular Age-related Macular Degeneration

Intervention / Treatment
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* Drug: FYB203 (Proposed aflibercept biosimilar)
* Drug: Eylea® (Aflibercept)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 50 years at Screening. Male or female: Male: A male patient must agree to use contraception as defined in this protocol during the treatment period 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: Not a woman of childbearing potential (WOCBP), OR A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 4 weeks after the last dose of study treatment. 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. Willingness and ability to undertake all scheduled visits and assessments. Newly diagnosed choroidal neovascularization (CNV) lesion secondary to wet AMD Exclusion Criteria: Patients are not eligible for the study if any of the following criteria apply: 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. Study eye requiring immediate treatment. Any prior treatment with VEGF agent or any investigational products to treat AMD in either eye. Uncontrolled ocular hypertension or glaucoma in the SE (defined as intraocular pressure [IOP] ≥ 30 mmHg, despite treatment with anti-glaucomatous medication). 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. 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. Use of other investigational drugs (excluding vitamins, minerals) within 30 days or 5 half lives from randomization, whichever is longer. 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. Stroke or myocardial infarction within 6 months prior to randomization. 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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FYB203 (Proposed aflibercept biosimilar)<br>Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol. | Drug: FYB203 (Proposed aflibercept biosimilar)<br>* Patients will receive 1 IVT injection of FYB203 every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.<br>|
| Active Comparator: Eylea® (Aflibercept)<br>Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol. | Drug: Eylea® (Aflibercept)<br>* Patients will receive 1 IVT injection of Eylea® every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Best Corrected Visual Acuity (BCVA) |  | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in retinal thickness |  | Through study completion, approximately 1 year | 
| Functional changes of the retina |  | Through study completion, approximately 1 year | 
| Proportion of patients who gain or lose pre-specified number of Early Treatment Diabetic Retinopathy Study (ETDRS) letters |  | Through study completion, approximately 1 year | 
| Absence of disease activity |  | Through study completion, approximately 1 year | 
| Concentration of aflibercept in blood |  | Through study completion, approximately 1 year | 
| Change in vision related functioning and wellbeing measured by National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25) |  | Through study completion, approximately 1 year | 
| Number of patients with anti-drug antibodies (ADAs) |  | Through study completion, approximately 1 year | 
| Frequency of local and systemic adverse events (AEs) and serious adverse events (SAEs) |  | Through study completion, approximately 1 year |