Clinical trial NCT04522167: Efficacy and Safety of the Aflibercept FYB203 Biosimilar in Comparison to Eylea® in Patients With Neovascular Age-Related Macular Degeneration
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neovascular Age-related Macular Degeneration
Lead sponsor: Bioeq GmbH
Sponsor class: INDUSTRY
First posted: 2020-08-21
Enrollment: 434
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Change from baseline in Best Corrected Visual Acuity (BCVA)
timeFrame: Week 8
Secondary outcomes:
measure: Change in retinal thickness
timeFrame: Through study completion, approximately 1 year
measure: Functional changes of the retina
timeFrame: Through study completion, approximately 1 year
measure: Proportion of patients who gain or lose pre-specified number of Early Treatment Diabetic Retinopathy Study (ETDRS) letters
timeFrame: Through study completion, approximately 1 year
measure: Absence of disease activity
timeFrame: Through study completion, approximately 1 year
measure: Concentration of aflibercept in blood
timeFrame: Through study completion, approximately 1 year
measure: Change in vision related functioning and wellbeing measured by National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25)
timeFrame: Through study completion, approximately 1 year
measure: Number of patients with anti-drug antibodies (ADAs)
timeFrame: Through study completion, approximately 1 year
measure: Frequency of local and systemic adverse events (AEs) and serious adverse events (SAEs)
timeFrame: Through study completion, approximately 1 year
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Research Site
city: Stara Zagora
country: Bulgaria
facility: Research Site
city: Hradec Králové
country: Czechia
facility: Research Site
city: Ostrava
country: Czechia
facility: Research Site
city: Pardubice
country: Czechia
facility: Research Site
city: Praha
country: Czechia
facility: Research Site
city: Sokolov
country: Czechia
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Pécs
country: Hungary
facility: Research Site
city: Szeged
country: Hungary
facility: Research Site
city: Szekesfehervar
country: Hungary
facility: Research Site
city: Tatabánya
country: Hungary
facility: Research Site
city: Zalaegerszeg
country: Hungary
facility: Research Site
city: Haifa
country: Israel
facility: Research Site
city: Jerusalem
country: Israel
facility: Research Site
city: Kfar Saba
country: Israel
facility: Research Site
city: Petah tikva
country: Israel
facility: Research Site
city: Rechovot
country: Israel
facility: Research Site
city: Rishon LeZion
country: Israel
facility: Research Site
city: Tel Aviv
country: Israel
facility: Research Site
city: Bologna
country: Italy
facility: Research Site
city: Firenze
country: Italy
facility: Research Site
city: Milan
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Rozzano
country: Italy
facility: Research Site
city: Udine
country: Italy
facility: Research Site
city: Akita
country: Japan
facility: Research Site
city: Amagasaki
country: Japan
facility: Research Site
city: Asahikawa
country: Japan
facility: Research Site
city: Chiyoda
country: Japan
facility: Research Site
city: Chuo
country: Japan
facility: Research Site
city: Fukuoka
country: Japan
facility: Research Site
city: Fukushima
country: Japan
facility: Research Site
city: Hamamatsu
country: Japan
facility: Research Site
city: Himeji
country: Japan
facility: Research Site
city: Hirakata
country: Japan
facility: Research Site
city: Kita
country: Japan
facility: Research Site
city: Kurume
country: Japan
facility: Research Site
city: Meguro
country: Japan
facility: Research Site
city: Nagasaki
country: Japan
facility: Research Site
city: Nagoya
country: Japan
facility: Research Site
city: Sapporo
country: Japan
facility: Research Site
city: Shinjuku-Ku
country: Japan
facility: Research Site
city: Suita
country: Japan
facility: Research Site
city: Toride
country: Japan
facility: Research Site
city: Yokosuka
country: Japan
facility: Research Site
city: Bielsko-Biala
country: Poland
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Kraków
country: Poland
facility: Research Site
city: Olsztyn
country: Poland
facility: Research Site
city: Tarnów
country: Poland
facility: Research Site
city: Warsaw
country: Poland
facility: Research Site
city: Łódź
country: Poland
facility: Research Site
city: Chelyabinsk
country: Russian Federation
facility: Research Site
city: Kazan
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kherson
country: Ukraine
facility: Research Site
city: Kropyvnytskyi
country: Ukraine
facility: Research Site
city: Luts'k
country: Ukraine
facility: Research Site
city: Odesa
country: Ukraine
facility: Research Site
city: Poltava
country: Ukraine
facility: Research Site
city: Zaporizhzhya
country: Ukraine
facility: Research Site
Study officials:
affiliation: Bioeq GmbH
name: Study Official
role: STUDY_DIRECTOR
References: