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CompletedNCT06708624Updated Nov 27, 2024

Ocular Safety and Usability Study for FYB201 PFS

A Phase 4 interventional study of FYB201 0.5 mg (0.05 mL of 10 mg/mL) in Age-Related Macular Degeneration, Branch Retinal Vein Occlusion with Macular Edema and Central Retinal Vein Occlusion with Macular Edema, sponsored by Formycon AG. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-27.

Sponsored by Formycon AG · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Aug 2024, 2 years 2 months ago, and no results have been posted to the registry.
  • Registered 5 months after the study started (first participant enrolled Jun 2024, registered Nov 2024).
Phase
Phase 4
Study type
Interventional
Enrollment
31
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Age-Related Macular Degeneration
  • Branch Retinal Vein Occlusion with Macular Edema
  • Central Retinal Vein Occlusion with Macular Edema
03

In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's enrollment of 31 is below the median of 51 across 985 interventional studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Formycon AG is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    FYB201 0.5 mg (0.05 mL of 10 mg/mL)

    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

    Drug: FYB201 0.5 mg (0.05 mL of 10 mg/mL)

Interventions

  • DrugFYB201 0.5 mg (0.05 mL of 10 mg/mL)

    IVT administration of FYB201 in a PFS

    Also known as: ranibizumab-eqrn

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 days

07

Study locations

4 sites
  • Research Site
    Campbell, California 95008, United States
  • Research Site
    Long Beach, California 90807, United States
  • Research Site
    Hagerstown, Maryland 21740, United States
  • Research Site
    Eugene, Oregon 97477, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06708624
Lead sponsor
Formycon AG
Responsible party
Sponsor
First posted
Nov 27, 2024
Start date
Jun 11, 2024
Primary completion
Aug 8, 2024
Completion
Aug 8, 2024
Last update
Nov 27, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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