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

• Status: Recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bioeq GmbH
• Treatments: Aflibercept

Criteria

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:

1. Not a woman of childbearing potential (WOCBP), OR

2. 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.