Neovascular Age-Related Macular Degeneration MedDRA version: 20.0 Level: PT Classification code 10071129 Term: Neovascular age-related macular degeneration System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Product Name: FYB203
Product Code: FYB203
Pharmaceutical Form: Solution for injection
INN or Proposed INN: aflibercept
CAS Number: 862111-32-8
Current Sponsor code: FYB203
Concentration unit: mg/ml mi
Sponsors
Bioeq GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Age = 50 years at Screening. 2.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: i)Not a woman of childbearing potential (WOCBP) OR ii)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 3.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. 4.Willingness and ability to undertake all scheduled visits and assessments. 5.Newly diagnosed choroidal neovascularization (CNV) lesion secondary to wet AMD Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 34 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 400
Exclusion criteria
Exclusion criteria: Patients are not eligible for the study if any of the following criteria apply: 1.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. 2.Study eye requiring immediate treatment. 3.Any prior treatment with VEGF agent or any investigational products to treat AMD in either eye. 4.Uncontrolled ocular hypertension or glaucoma in the SE (defined as intraocular pressure [IOP] = 30 mmHg, despite treatment with anti-glaucomatous medication). 5.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. 6.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. 7.Use of other investigational drugs (excluding vitamins, minerals) within 30 days or 5 half lives from randomization, whichever is longer. 8.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. 9.Stroke or myocardial infarction within 6 months prior to randomization. 10.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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate and compare functional changes in best corrected visual acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letters at Week 8 of treatment with FYB203 or Eylea compared to baseline ;Secondary Objective: •Evaluate and compare changes in retinal thickness over time •Evaluate and compare functional changes of the retina by BCVA over time •Evaluate and compare the proportion of patients who gain or lose = 5, 10, and 15 ETDRS letters compared to baseline •Evaluate and compare the absence of disease activity (fluid-free macula) over time •Evaluate and compare systemic aflibercept concentrations in a subgroup of patients •Evaluate and compare change in vision related functioning and well-being measured by National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25) •Evaluate and compare immunogenicity and safety ;Primary end point(s): •Changes from Baseline Visit in BCVA by ETDRS letters to Week 8 ;Timepoint(s) of evaluation of this end point: week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Changes of retinal thickness •Evaluate and compare change in total lesion size •Change of BCVA by ETDRS letters over the whole study •Proportion of patients who gain or lose = 5, 10, or 15 ETDRS letters from Baseline •Percentage of patients with fluid-free macula at each Visit •Systemic concentrations of aflibercept in a subgroup at selected sites •Number of patients with ADAs over time •Frequency of local and systemic AEs and SAEs;Timepoint(s) of evaluation of this end point: Various timepoints as detailed in the protocol | — |
Countries
Bulgaria, Czechia, Czech Republic, Hungary, Italy, Japan, Poland, Russian Federation, Ukraine
Contacts
Public ContactClinical Trial Information Desk
Bioeq GmbH
Outcome results
None listed