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Trial record 1 of 1 for:    FYB203
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Efficacy and Safety of the Aflibercept FYB203 Biosimilar in Comparison to Eylea® in Patients With Neovascular Age-Related Macular Degeneration (MAGELLAN-AMD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04522167
Recruitment Status : Recruiting
First Posted : August 21, 2020
Last Update Posted : August 21, 2020
Sponsor:
Information provided by (Responsible Party):
Bioeq GmbH

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.

Condition or disease Intervention/treatment Phase
Neovascular Age-related Macular Degeneration Drug: FYB203 (Proposed aflibercept biosimilar) Drug: Eylea® (Aflibercept) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : July 21, 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FYB203 (Proposed aflibercept biosimilar)
Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.
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.

Active Comparator: Eylea® (Aflibercept)
Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.
Drug: 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.




Primary Outcome Measures :
  1. Change from baseline in Best Corrected Visual Acuity (BCVA) [ Time Frame: Week 8 ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04522167


Contacts
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Contact: bioeq GmbH +49802446333299 magellan@bioeq.com

Locations
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Bulgaria
Research Site Recruiting
Sofia, Bulgaria
Research Site Recruiting
Stara Zagora, Bulgaria
Czechia
Research Site Recruiting
Praha, Czechia
Poland
Research Site Recruiting
Bydgoszcz, Poland
Research Site Recruiting
Olsztyn, Poland
Research Site Recruiting
Warsaw, Poland
Sponsors and Collaborators
Bioeq GmbH
Investigators
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Study Director: Study Official Bioeq GmbH
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Responsible Party: Bioeq GmbH
ClinicalTrials.gov Identifier: NCT04522167    
Other Study ID Numbers: FYB203-03-01
First Posted: August 21, 2020    Key Record Dates
Last Update Posted: August 21, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases