Neovascular Age-Related Macular Degeneration
Conditions
Interventions
investigational material(s)
Generic name etc : FYB203
INN of investigational material : aflibercept
Therapeutic category code : 131 Agents for ophthalmic use
Dosage and Administration for Investigatio
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 (48 weeks) 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 (48 weeks) 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 (within 6 months of Screening Visit), angiographically documented, treatment-naive choroidal neovascularization (CNV) lesion secondary to wet AMD
Exclusion criteria
Exclusion criteria: 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 |
|---|---|
| safety efficacy Changes from Baseline Visit in BCVA by ETDRS letters to Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy -Changes of retinal thickness -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 | — |
Countries
Europe, Japan
Contacts
Public ContactjRCT Inquiry Contact IQVIA Services Japan G.K.
IQVIA Services Japan G.K.
Outcome results
None listed