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Ocular Safety and Usability Study for FYB203 PFS | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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)

NCT06708637•Formycon AG

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+4 more criteria

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.

Locations (4)

Research Site

Campbell, California, United States

Research Site

Long Beach, California, United States

Research Site

Redlands, California, United States

Research Site

Eugene, Oregon, United States

Key Dates

Start Date

September 20, 2024

Primary Completion Date

October 8, 2024

Completion Date

October 8, 2024

Last Updated

November 27, 2024

Enrollment

ACTUAL participants

Conditions

Age-Related Macular DegenerationBranch Retinal Vein Occlusion with Macular EdemaCentral Retinal Vein Occlusion with Macular EdemaDiabetic Macular EdemaDiabetic Retinopathy

Interventions

FYB203 2 mg (0.05 mL of 40 mg/mL)

DRUG

Direct Discrimination of Quantum States by the Human Eye

NCT05913063

Age-Related Macular Degeneration

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 27, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Ocular Safety and Usability Study for FYB203 PFS

Inclusion Criteria

Exclusion Criteria

Direct Discrimination of Quantum States by the Human Eye

Phase 2 Study of ADX-038 in Participants With Geographic Atrophy

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