Ocular Safety and Usability Study for FYB203 PFS

An Open-Label, Multi-Center, Single-Arm Study to Evaluate the Ocular Safety and Usability of FYB203 Pre-filled Syringe (PFS)

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.

Study Overview

• Status: Completed
• Conditions: Age-Related Macular Degeneration; Diabetic Retinopathy; Diabetic Macular Edema; Branch Retinal Vein Occlusion with Macular Edema; Central Retinal Vein Occlusion with Macular Edema
• Intervention / Treatment: Drug: FYB203 2 mg (0.05 mL of 40 mg/mL)

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Campbell, California, United States, 95008
      • Research Site
    • Long Beach, California, United States, 90807
      • Research Site
    • Redlands, California, United States, 92374
      • Research Site
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Study eye deemed to be indicated for aflibercept IVT injection therapy at the discretion of the Investigator.
2. Written and signed informed consent form (ICF) obtained before any study-related procedures.
3. Had a confirmed diagnosis in one or both eyes of neovascular (wet) AMD or macular edema following RVO or DME or DR.
4. Qualified for treatment with aflibercept according to the United States Prescribing Information.
5. Aged ≥18 years at the time of signing ICF.
6. If a subject was already on an aflibercept regimen, timing of study participation was correlated with the regimen.
7. 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.
8. Male study subject agreed not to donate sperm starting from screening and throughout the clinical study period and for 3 months after IP administration.

9. Female study subject was categorized by at least one of the following:

   • Not a woman of childbearing potential as described in Appendix 3 of the study protocol prior to signing ICF, or
   • Surgically sterile or had undergone a hysterectomy as categorized in Appendix 3 of the study protocol at least 1 month prior to signing ICF, or
   • Was using a highly effective contraception. All females of childbearing potential were required to use highly effective contraception (as described in Appendix 3 of the study protocol) starting at signing ICF and throughout the clinical study period and for 3 months after IP administration.
10. Female study subject must not be lactating and must not be breastfeeding at screening until 3 months after IP administration.
11. 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:

1. Had received IVT injection in the study eye within 3 months prior to Day 1 with any anti vascular endothelial growth factor therapy other than aflibercept products (ege.g., Eylea).
2. Intraocular corticosteroid administration in the study eye within 30 days prior to Day 1.
3. Had fever or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non cutaneous) infection within 1 week prior to Day 1.
4. History or evidence of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection in the last month prior to signing ICF or had been in confirmed contact with SARS-CoV-2 positive subjects in the last 2 weeks before dosing.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FYB203 2 mg (0.05 mL of 40 mg/mL); FYB203 provided in a pre-filled syringe (PFS), containing 2 mg of 40 mg/mL aflibercept in 0.05 mL for intravitreal (IVT) administration	Drug: FYB203 2 mg (0.05 mL of 40 mg/mL); IVT administration of FYB203 in a PFS; Other Names: aflibercept-mrbb

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Formycon AG

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2024
• Primary Completion (Actual): October 8, 2024
• Study Completion (Actual): October 8, 2024

Study Registration Dates

• First Submitted: November 25, 2024
• First Submitted That Met QC Criteria: November 25, 2024
• First Posted (Estimated): November 27, 2024

Study Record Updates

• Last Update Posted (Estimated): November 27, 2024
• Last Update Submitted That Met QC Criteria: November 25, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Eye Diseases; Diabetic Angiopathies; Diabetes Complications; Embolism and Thrombosis; Retinal Diseases; Retinal Degeneration; Venous Thrombosis; Thrombosis; Diabetic Retinopathy; Edema; Macular Degeneration; Macular Edema; Retinal Vein Occlusion; Antineoplastic Agents; Physiological Effects of Drugs; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Aflibercept
• Other Study ID Numbers: FYB203-04-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No