CompletedPhase 4

Ocular Safety and Usability Study for FYB203 PFS

United States30 participantsStarted 2024-09-20

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence and occurrence of ocular and non-ocular Adverse Events (AEs) and Serious Adverse Events (SAEs) occurring after IVT injection

Timeframe: 2 days

Trial details

NCT IDNCT06708637

SponsorFormycon AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-08

View on ClinicalTrials.gov More Age-Related Macular Degeneration trials