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The objective of the study is to assess the ocular safety of the FYB203 pre-filled syringe in terms of preparation and administration by Retina Specialists in the clinical setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FYB203 2 mg (0.05 mL of 40 mg/mL) | Experimental | FYB203 provided in a pre-filled syringe (PFS), containing 2 mg of 40 mg/mL aflibercept in 0.05 mL for intravitreal (IVT) administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FYB203 2 mg (0.05 mL of 40 mg/mL) | Drug | IVT administration of FYB203 in a PFS |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and occurrence of ocular and non-ocular Adverse Events (AEs) and Serious Adverse Events (SAEs) occurring after IVT injection | To assess the ocular safety of the FYB203 PFS in terms of preparation and administration by Retina Specialists. | 2 days |
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Inclusion Criteria:
Study eye deemed to be indicated for aflibercept IVT injection therapy at the discretion of the Investigator.
Written and signed informed consent form (ICF) obtained before any study-related procedures.
Had a confirmed diagnosis in one or both eyes of neovascular (wet) AMD or macular edema following RVO or DME or DR.
Qualified for treatment with aflibercept according to the United States Prescribing Information.
Aged ≥18 years at the time of signing ICF.
If a subject was already on an aflibercept regimen, timing of study participation was correlated with the regimen.
Male study subject (if his female spouse/partner was of childbearing potential) must have confirmed that he was using two acceptable methods for contraception (one of which must be a barrier method) starting at signing ICF and throughout the clinical study period and for 3 months after IP administration. Male study subject must have agreed to inform his partner of participation in the study and the need to avoid pregnancy. Surgically sterilized and non sexually active male subjects did not require any additional use of contraception.
Male study subject agreed not to donate sperm starting from screening and throughout the clinical study period and for 3 months after IP administration.
Female study subject was categorized by at least one of the following:
Female study subject must not be lactating and must not be breastfeeding at screening until 3 months after IP administration.
Female study subject must not donate ova starting at signing ICF and throughout the clinical study period and for 3 months after IP administration.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Campbell | California | 95008 | United States | ||
| Research Site |
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| Long Beach |
| California |
| 90807 |
| United States |
| Research Site | Redlands | California | 92374 | United States |
| Research Site | Eugene | Oregon | 97401 | United States |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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