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

Neovascular Age-related Macular Degeneration Clinical Trial

— MAGELLAN-AMD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04522167
• Other study ID #: FYB203-03-01
• Status: Completed
• Phase: Phase 3
• Start date: July 21, 2020
• Est. completion date: May 18, 2023

Study information

• Verified date: June 2023
• Source: Bioeq GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 434
• Est. completion date: May 18, 2023
• Est. primary completion date: June 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• FYB203 (Proposed aflibercept biosimilar)
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.
• Eylea® (Aflibercept)
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.

Locations

Country	Name	City	State
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Stara Zagora
Czechia	Research Site	Hradec Králové
Czechia	Research Site	Ostrava
Czechia	Research Site	Pardubice
Czechia	Research Site	Praha
Czechia	Research Site	Sokolov
Hungary	Research Site	Budapest
Hungary	Research Site	Debrecen
Hungary	Research Site	Pécs
Hungary	Research Site	Szeged
Hungary	Research Site	Szekesfehervar
Hungary	Research Site	Tatabánya
Hungary	Research Site	Zalaegerszeg
Israel	Research Site	Haifa
Israel	Research Site	Jerusalem
Israel	Research Site	Kfar Saba
Israel	Research Site	Petah tikva
Israel	Research Site	Rechovot
Israel	Research Site	Rishon LeZion
Israel	Research Site	Tel Aviv
Italy	Research Site	Bologna
Italy	Research Site	Firenze
Italy	Research Site	Milan
Italy	Research Site	Roma
Italy	Research Site	Rozzano
Italy	Research Site	Udine
Japan	Research Site	Akita
Japan	Research Site	Amagasaki
Japan	Research Site	Asahikawa
Japan	Research Site	Chiyoda
Japan	Research Site	Chuo
Japan	Research Site	Fukuoka
Japan	Research Site	Fukushima
Japan	Research Site	Hamamatsu
Japan	Research Site	Himeji
Japan	Research Site	Hirakata
Japan	Research Site	Kita
Japan	Research Site	Kurume
Japan	Research Site	Meguro
Japan	Research Site	Nagasaki
Japan	Research Site	Nagoya
Japan	Research Site	Sapporo
Japan	Research Site	Shinjuku-Ku
Japan	Research Site	Suita
Japan	Research Site	Toride
Japan	Research Site	Yokosuka
Poland	Research Site	Bielsko-Biala
Poland	Research Site	Bydgoszcz
Poland	Research Site	Kraków
Poland	Research Site	Lódz
Poland	Research Site	Olsztyn
Poland	Research Site	Tarnów
Poland	Research Site	Warsaw
Russian Federation	Research Site	Chelyabinsk
Russian Federation	Research Site	Kazan
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Novosibirsk
Russian Federation	Research Site	Saint Petersburg
Ukraine	Research Site	Kharkiv
Ukraine	Research Site	Kherson
Ukraine	Research Site	Kropyvnytskyi
Ukraine	Research Site	Luts'k
Ukraine	Research Site	Odesa
Ukraine	Research Site	Poltava
Ukraine	Research Site	Zaporizhzhya

Sponsors (1)

Lead Sponsor	Collaborator
Bioeq GmbH

Countries where clinical trial is conducted

Bulgaria,  Czechia,  Hungary,  Israel,  Italy,  Japan,  Poland,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Best Corrected Visual Acuity (BCVA)		Week 8
Secondary	Change in retinal thickness		Through study completion, approximately 1 year
Secondary	Functional changes of the retina		Through study completion, approximately 1 year
Secondary	Proportion of patients who gain or lose pre-specified number of Early Treatment Diabetic Retinopathy Study (ETDRS) letters		Through study completion, approximately 1 year
Secondary	Absence of disease activity		Through study completion, approximately 1 year
Secondary	Concentration of aflibercept in blood		Through study completion, approximately 1 year
Secondary	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
Secondary	Number of patients with anti-drug antibodies (ADAs)		Through study completion, approximately 1 year
Secondary	Frequency of local and systemic adverse events (AEs) and serious adverse events (SAEs)		Through study completion, approximately 1 year