Efficacy and Safety of the Aflibercept FYB203 Biosimilar in Comparison to Eylea® in Patients With Neovascular Age-Related Macular Degeneration
NCT ID: NCT04522167
Last Updated: 2025-11-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
434 participants
INTERVENTIONAL
2020-07-21
2023-05-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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FYB203 (Proposed aflibercept biosimilar)
Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.
FYB203 (Proposed aflibercept biosimilar)
Patients will receive 1 IVT injection of FYB203 in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
Eylea® (Aflibercept)
Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.
Eylea® (Aflibercept)
Patients will receive 1 IVT injection of Eylea® in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
Interventions
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FYB203 (Proposed aflibercept biosimilar)
Patients will receive 1 IVT injection of FYB203 in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
Eylea® (Aflibercept)
Patients will receive 1 IVT injection of Eylea® in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
50 Years
ALL
No
Sponsors
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Bioeq GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Study Official
Role: STUDY_DIRECTOR
Bioeq GmbH
Locations
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Research Site
Sofia, , Bulgaria
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Stara Zagora, , Bulgaria
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Hradec Králové, , Czechia
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Ostrava, , Czechia
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Pardubice, , Czechia
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Prague, , Czechia
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Sokolov, , Czechia
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Budapest, , Hungary
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Debrecen, , Hungary
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Pécs, , Hungary
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Szeged, , Hungary
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Székesfehérvár, , Hungary
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Tatabánya, , Hungary
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Zalaegerszeg, , Hungary
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Haifa, , Israel
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Jerusalem, , Israel
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Kfar Saba, , Israel
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Petah Tikva, , Israel
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Rehovot, , Israel
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Rishon LeZiyyon, , Israel
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Tel Aviv, , Israel
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Bologna, , Italy
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Florence, , Italy
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Milan, , Italy
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Roma, , Italy
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Rozzano, , Italy
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Udine, , Italy
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Akita, , Japan
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Amagasaki, , Japan
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Asahikawa, , Japan
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Chiyoda City, , Japan
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Chūō, , Japan
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Fukuoka, , Japan
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Fukushima, , Japan
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Hamamatsu, , Japan
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Himeji, , Japan
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Hirakata, , Japan
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Kita-ku, , Japan
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Kurume, , Japan
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Meguro City, , Japan
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Nagasaki, , Japan
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Nagoya, , Japan
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Sapporo, , Japan
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Shinjuku-Ku, , Japan
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Suita, , Japan
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Toride, , Japan
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Yokosuka, , Japan
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Bielsko-Biala, , Poland
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Bydgoszcz, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Olsztyn, , Poland
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Tarnów, , Poland
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Warsaw, , Poland
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Chelyabinsk, , Russia
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Kazan', , Russia
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Moscow, , Russia
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Novosibirsk, , Russia
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Saint Petersburg, , Russia
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Kharkiv, , Ukraine
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Kherson, , Ukraine
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Kropyvnytskyi, , Ukraine
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Lutsk, , Ukraine
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Odesa, , Ukraine
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Poltava, , Ukraine
Research Site
Zaporizhzhya, , Ukraine
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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FYB203-03-01
Identifier Type: -
Identifier Source: org_study_id