Clinical trial NCT06708624: Ocular Safety and Usability Study for FYB201 PFS
Official title: An Open-Label, Multi-Center, Single-Arm Study to Evaluate the Ocular Safety and Usability of FYB201 Pre-filled Syringe (PFS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Age-Related Macular Degeneration
Branch Retinal Vein Occlusion with Macular Edema
Central Retinal Vein Occlusion with Macular Edema
Lead sponsor: Formycon AG
Sponsor class: INDUSTRY
First posted: 2024-11-27
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Study eye deemed to be indicated for ranibizumab intravitreal injection therapy at the discretion of the Investigator.
2. Written and signed informed consent form (ICF) obtained before any study-related procedures are performed.
3. 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).
4. Qualifies for treatment with ranibizumab-eqrn according to the USPI.
5. Aged ≥18 years at the time of signing ICF.
6. If a subject is already on a ranibizumab regimen, timing of study participation should correlate with the regimen.
7. 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.
8. 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.
9. Female study subject must be categorized by at least one of the following:

   * Not a Woman of Child-bearing Potential as described in Appendix 3 prior to signing ICF; or
   * Surgically sterile or having undergone a hysterectomy as categorized in Appendix 3 at least 1 month prior to signing ICF; or
   * Is using a highly effective contraception. All females of childbearing potential will be required to use highly effective contraception (as described in Appendix 3) starting at signing ICF and throughout the clinical study period and for 3 months after study drug administration.
10. Female study subject must not be lactating and must not be breastfeeding at screening until 3 months after study drug administration.
11. 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:

1. Have received IVT injection in the study eye within 3 months prior to Day 1 with any anti-VEGF therapy other than ranibizumab products (e.g. Lucentis®, Cimerli®, Byooviz®).
2. Intraocular corticosteroid administration in the study eye within 30 day prior to Day 1.
3. The study subject has/had fever or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to Day 1.
4. The study subjects with a history or evidence of SARS-CoV-2 infection in the last month prior to signing ICF or having been in confirmed contact with SARS-CoV-2 positive patients in the last 2 weeks before dosing.

Primary outcomes:
measure: Incidence and occurrence of ocular and non-ocular Adverse Events (AEs) and Serious Adverse Events (SAEs) occurring after IVT injection
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Campbell
country: United States
facility: Research Site
state: California
city: Long Beach
country: United States
facility: Research Site
state: California
city: Hagerstown
country: United States
facility: Research Site
state: Maryland
city: Eugene
country: United States
facility: Research Site
state: Oregon
Study officials:
References: