Age-Related Macular DegenerationPhase 4NCT06708624
Ocular Safety and Usability Study for FYB201 PFS
A Phase 4 study testing FYB201 0.5 mg (0.05 mL of 10 mg/mL) in people with Age-Related Macular Degeneration and Branch Retinal Vein Occlusion with Macular Edema, run by Formycon AG at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Age-Related Macular Degeneration, Branch Retinal Vein Occlusion with Macular Edema, Central Retinal Vein Occlusion with Macular Edema
- What is being tested?
- FYB201 0.5 mg (0.05 mL of 10 mg/mL)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 4 sitesUnited States
- Study dates
- 11 Jun 2024to 8 Aug 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Study eye deemed to be indicated for ranibizumab intravitreal injection therapy at the discretion of the Investigator.
- Written and signed informed consent form (ICF) obtained before any study-related procedures are performed.
- 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).
- Qualifies for treatment with ranibizumab-eqrn according to the USPI.
- Aged ≥18 years at the time of signing ICF.
- If a subject is already on a ranibizumab regimen, timing of study participation should correlate with the regimen.
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- 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.
- 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.
- 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.
- Female study subject must not be lactating and must not be breastfeeding at screening until 3 months after study drug administration.
- 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.
Who cannot join
- 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®).
- Intraocular corticosteroid administration in the study eye within 30 day prior to Day 1.
- 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.
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Research Site
Campbell, California, 95008
Research Site
Eugene, Oregon, 97477
Research Site
Hagerstown, Maryland, 21740
Research Site
Long Beach, California, 90807
About this study
Official title: An Open-Label, Multi-Center, Single-Arm Study to Evaluate the Ocular Safety and Usability of FYB201 Pre-filled Syringe (PFS)
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.
- Conditions
- Age-Related Macular Degeneration, Branch Retinal Vein Occlusion with Macular Edema, Central Retinal Vein Occlusion with Macular Edema
- Being tested
- FYB201 0.5 mg (0.05 mL of 10 mg/mL)
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FYB201 0.5 mg (0.05 mL of 10 mg/mL)Drug
Also called ranibizumab-eqrn
IVT administration of FYB201 in a PFS
| Study group | Role | What they receive |
|---|---|---|
| FYB201 0.5 mg (0.05 mL of 10 mg/mL) | Experimental | 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 Receives: Drug: FYB201 0.5 mg (0.05 mL of 10 mg/mL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start11 Jun 2024
- Primary completion8 Aug 2024
- Study completion8 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Formycon AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06708624
- Sponsor's protocol ID
- FYB201-C3-02
- Status last verified
- Nov 2024
- First submitted
- 25 Nov 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multi-Center, Single-Arm Study to Evaluate the Ocular Safety and Usability of FYB201 Pre-filled Syringe (PFS)
- ClinicalTrials.gov ID
- NCT06708624
- Acronym / sponsor ID
- FYB201-C3-02
- Conditions
- Age-Related Macular Degeneration, Branch Retinal Vein Occlusion with Macular Edema, Central Retinal Vein Occlusion with Macular Edema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Formycon AGIndustry (pharma, biotech, devices)
- Study start
- 11 Jun 2024 (actual)
- Primary completion
- 8 Aug 2024 (actual)
- Study completion
- 8 Aug 2024 (actual)
- First posted
- 27 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FYB201 0.5 mg (0.05 mL of 10 mg/mL) | Experimental | Drug: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Study eye deemed to be indicated for ranibizumab intravitreal injection therapy at the discretion of the Investigator.
- Written and signed informed consent form (ICF) obtained before any study-related procedures are performed.
- 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).
- Qualifies for treatment with ranibizumab-eqrn according to the USPI.
- Aged ≥18 years at the time of signing ICF.
Key exclusion criteria (4 listed)
- 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®).
- Intraocular corticosteroid administration in the study eye within 30 day prior to Day 1.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FYB201 0.5 mg (0.05 mL of 10 mg/mL)Also: ranibizumab-eqrnIVT administration of FYB201 in a PFS | Drug | FYB201 0.5 mg (0.05 mL of 10 mg/mL) |
Primary outcome
Incidence and occurrence of ocular and non-ocular Adverse Events (AEs) and Serious Adverse Events (SAEs) occurring after IVT injection
Time frame: 2 days
To assess the ocular safety of the FYB201 PFS in terms of preparation and administration by Retina Specialists.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing FYB201 0.5 mg (0.05 mL of 10 mg/mL) in people with Age-Related Macular Degeneration and Branch Retinal Vein Occlusion with Macular Edema, run by Formycon AG at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and occurrence of ocular and non-ocular Adverse Events (AEs) and Serious Adverse Events (SAEs) occurring after IVT injection (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.