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The objective of the study is to assess the ocular safety of the FYB201 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 |
|---|---|---|---|
| FYB201 0.5 mg (0.05 mL of 10 mg/mL) | Experimental | FYB201 provided in a pre-filled syringe (PFS), containing 0.5 mg of 10 mg/mL ranibizumab in 0.05 mL for intravitreal (IVT) administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FYB201 0.5 mg (0.05 mL of 10 mg/mL) | Drug | IVT administration of FYB201 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 FYB201 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 ranibizumab intravitreal injection therapy at the discretion of the Investigator.
Written and signed informed consent form (ICF) obtained before any study-related procedures are performed.
Have a confirmed diagnosis in one or both eyes of Neovascular (Wet) Age-Related Macular Degeneration (AMD) or Macular Edema Following Retinal Vein Occlusion (RVO).
Qualifies for treatment with ranibizumab-eqrn according to the USPI.
Aged ≥18 years at the time of signing ICF.
If a subject is already on a ranibizumab regimen, timing of study participation should correlate with the regimen.
Male study subject (if his female spouse/partner is of childbearing potential) must confirm that he is 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 study drug administration. Male study subject should agree to inform his partner of participation in the study and the need to avoid pregnancy. Surgically sterilized and non-sexually active male subjects do not require additional use of contraception.
Male study subject agrees not to donate sperm starting from screening and throughout the clinical study period and for 3 months after study drug administration.
Female study subject must be 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 study drug administration.
Female study subject must not donate ova starting at signing ICF and throughout the clinical study period and for 3 months after study drug 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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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| Long Beach |
| California |
| 90807 |
| United States |
| Research Site | Hagerstown | Maryland | 21740 | United States |
| Research Site | Eugene | Oregon | 97477 | United States |