Non-infectious Uveitis Affecting the Posterior Segment of the EyePhase 4NCT06539481
Open Label Trial Studying the Safety and Effectiveness of ILUVIEN® (190μg) in Children and Adolescents, Who Have Recurrent Non-infectious Uveitis Affecting the Posterior Segment of the Eye.
A Phase 4 study testing fluocinolone acetonide 190 micrograms in people with Non-infectious Uveitis Affecting the Posterior Segment of the Eye, run by Alimera Sciences at 6 sites in 3 countries.
Trial summary
The main aim is to test how safe and effective the medicine ILUVIEN® (190μg) is for children and adolescents, who have non-infectious uveitis that keeps coming back and affects the back of the eye. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Non-infectious Uveitis Affecting the Posterior Segment of the Eye
- What is being tested?
- fluocinolone acetonide 190 micrograms
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 31 Aug 2024to 31 Oct 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Males and females of ≥6 and <18 years of age at time of consent
- Non-infectious posterior, intermediate or panuveitis in the study eye with a history of recurrence ≥1 per year as assessed by the Investigator
- Uveitis in the study eye not adequately controlled by the preferred standard of care due to intolerable adverse effects or poor response, in the judgment of the Investigator
- Treatment with systemic corticosteroid or other systemic therapies given for at least 3 months within the previous 12 months prior to Day 1
Who cannot join
- History of intraocular surgery in the study eye within 90 days of the screening visit.
- Hypersensitivity to FA or any component of ILUVIEN®
- History of any form of glaucoma or ocular hypertension in study eye, unless study eye has been previously treated with an incisional IOP-lowering surgical procedure at least 90 days prior to the screening visit and that procedure has resulted in stable IOP in the normal range (10-21 mmHg)
- Increased intraocular pressure >25 mmHg or that required treatment including increases in medications, surgery (other than drainage surgery), or hospitalisations, within 4 weeks prior to baseline that, in the opinion of the Investigator, would pose an unacceptable risk to the patient participating in the study
Trial locations and contacts
6 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 3 countries
Germany2 sites, 2 recruiting
- Not yet recruiting
Charité - Universitätsmedizin Berlin Institute of Health Department of Ophthalmology
Berlin
clinicaltrials@alimerasciences.com
- Recruiting
Augenzentrum am St. Franziskus-Hospital Münster
Münster
clinicaltrials@alimerasciences.com
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitario Cruces
Bilbao
clinicaltrials@alimerasciences.com
- Recruiting
Fundación Jiménez Díaz
Madrid
clinicaltrials@alimerasciences.com
United Kingdom2 sites, 2 recruiting
- Recruiting
University of Bristol Bristol Medical School
Bristol
clinicaltrials@alimerasciences.com
- Recruiting
Sheffield Teaching Hospitals NHS Foundation Trust and Sheffield Children NHS Foundation Trust
Sheffield
clinicaltrials@alimerasciences.com
About this study
Official title: A Non-randomised, Open-label, Uncontrolled, Multi-centre, Phase IIIb Study Evaluating the Safety and Efficacy of Fluocinolone Acetonide 190 Micrograms Intravitreal Implant in Paediatric Subjects From 6 Years to Less Than 18 Years With Recurrent Non-infectious Uveitis Affecting the Posterior Segment of the Eye
The main aim is to test how safe and effective the medicine ILUVIEN® (190μg) is for children and adolescents, who have non-infectious uveitis that keeps coming back and affects the back of the eye.
The main thing Alimera wants to find out is how well the implant works for treating non-infectious uveitis in the back of the eye. Treatment success will be measured after 6 months of using the implant.
Read more
The treatment will be considered successful if two things happen:
- No swelling in the back of the eye called cystoid macular oedema;
- A decrease in the cloudiness inside the eye, called vitreous haze, by at least two levels compared to how it was before the treatment, or the vitreous haze is completely gone.
Participants will:
- Receive a single treatment with ILUVIEN®, which is a tiny tube that is to be implanted in the eye and releases low levels of the corticosteroid (fluocinolone acetonide) in the eye for up to 36 months.
- Be followed for 36 months for checkups and tests
- Being tested
- fluocinolone acetonide 190 micrograms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluocinolone acetonide 190 microgramsDrug
ILUVIEN®, is a tiny tube that is to be implanted in the eye and releases low levels of the corticosteroid (fluocinolone acetonide) in the eye. ILUVIEN® delivers corticosteroid directly to the intended site of action for up to 36 months.
| Study group | Role | What they receive |
|---|---|---|
| ILUVIEN® 190μg | Experimental | Not described Receives: Drug: fluocinolone acetonide 190 micrograms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of cystoid macular oedema on Optical Coherence Tomography and a decrease from baseline in vitreous haze grade of ≥2 steps, or absence of vitreous haze.
The primary endpoint for evaluating the effect of the implant on non-infectious uveitis affecting the posterior segment of the eye will be based on treatment success, determined at 6 months after administration. Treatment success will be determined based on a composite variable defined as Absence of cystoid macular oedema on Optical Coherence Tomography and a decrease from baseline in vitreous haze grade of ≥2 steps, or absence of vitreous haze.
Measured: 6 months after administration
Rate of cataract formation and Rate of IOP elevation
The primary endpoint for evaluating the safety of the implant on non-infectious uveitis affecting the posterior segment of the eye will be determined.
- Rate of cataract formation
- Rate of IOP elevation (Change from baseline in IOP and incidence of significant changes in IOP, including: IOP>21 mmHg, IOP>25 mmHg, IOP>30 mmHg, increases from baseline of 10 mmHg or more).
Measured: 6 months after administration
Secondary outcomes (2)
Changes in vision and incidence of increase in IOP, AE, and uveitis recurrence
- Absence of CMO and decrease from baseline in vitreous haze grade of ≥2 steps, or absence of vitreous haze at end of the study
- Uveitis recurrence rate following treatment, compared to the uveitis recurrence rate over the 12 months prior to enrolment
- Incidence of recurrence of non-infectious uveitis affecting the posterior segment in the SE and in the FE after receiving study treatment
- Time to recurrence of non-infectious uveitis affecting the posterior segment
- Change in macular oedema,
- Change in BCVA
- Change in vitreous haze
- Change in AC cell grade
- Incidence of secondary increase in IOP and secondary increase in IOP requiring surgical intervention
- Incidence and onset of secondary lens opacity and extraction
- Number of adjunctive treatments required to treat recurrences of uveitis
- Presence of active chorioretinal
- Presence of retinal vascular lesions
- Incidence of ocular infection
- Incidence of AEs
- Change from baseline in cup-to-disc ratio
Measured: Every 6 months over 3 years
Incidence of secondary increase in IOP, secondary increase in IOP requiring surgical intervention, and ocular and non-ocular AEs.
Mandatory safety measures including IOP checks will be performed every 3 months.
The following secondary safety endpoints will be assessed at 6 months, 12 months or 36 months
- Incidence of secondary increase in IOP
- Incidence of secondary increase in IOP requiring surgical intervention
- Incidence of ocular and non-ocular AEs.
Measured: 3, 6, 12, and 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start31 Aug 2024 (estimated)
- Primary completion15 Jul 2026 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-infectious Uveitis Affecting the Posterior Segment of the EyeStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alimera Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539481
- Sponsor's protocol ID
- ALI-P01-21-006
- Status last verified
- Jul 2024
- First submitted
- 30 Jul 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-randomised, Open-label, Uncontrolled, Multi-centre, Phase IIIb Study Evaluating the Safety and Efficacy of Fluocinolone Acetonide 190 Micrograms Intravitreal Implant in Paediatric Subjects From 6 Years to Less Than 18 Years With Recurrent Non-infectious Uveitis Affecting the Posterior Segment of the Eye
- ClinicalTrials.gov ID
- NCT06539481
- Acronym / sponsor ID
- ALI-P01-21-006
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Alimera SciencesIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2024 (estimated)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 6 Aug 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 main aim is to test how safe and effective the medicine ILUVIEN® (190μg) is for children and adolescents, who have non-infectious uveitis that keeps coming back and affects the back of the eye.
The main thing Alimera wants to find out is how well the implant works for treating non-infectious uveitis in the back of the eye. Treatment success will be measured after 6 months of using the implant.
The treatment will be considered successful if two things happen:
- No swelling in the back of the eye called cystoid macular oedema;
- A decrease in the cloudiness inside the eye, called vitreous haze, by at least two levels compared to how it was before the treatment, or the vitreous haze is completely gone.
Participants will:
- Receive a single treatment with ILUVIEN®, which is a tiny tube that is to be implanted in the eye and releases low levels of the corticosteroid (fluocinolone acetonide) in the eye for up to 36 months.
- Be followed for 36 months for checkups and tests
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ILUVIEN® 190μg | Experimental | Drug: fluocinolone acetonide 190 micrograms |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Males and females of ≥6 and <18 years of age at time of consent
- Non-infectious posterior, intermediate or panuveitis in the study eye with a history of recurrence ≥1 per year as assessed by the Investigator
- Uveitis in the study eye not adequately controlled by the preferred standard of care due to intolerable adverse effects or poor response, in the judgment of the Investigator
- Treatment with systemic corticosteroid or other systemic therapies given for at least 3 months within the previous 12 months prior to Day 1
Key exclusion criteria (4 listed)
- History of intraocular surgery in the study eye within 90 days of the screening visit.
- Hypersensitivity to FA or any component of ILUVIEN®
- History of any form of glaucoma or ocular hypertension in study eye, unless study eye has been previously treated with an incisional IOP-lowering surgical procedure at least 90 days prior to the screening visit and that procedure has resulted in stable IOP in the normal range (10-21 mmHg)
- Increased intraocular pressure >25 mmHg or that required treatment including increases in medications, surgery (other than drainage surgery), or hospitalisations, within 4 weeks prior to baseline that, in the opinion of the Investigator, would pose an unacceptable risk to the patient participating in the study
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 |
|---|---|---|
| fluocinolone acetonide 190 microgramsILUVIEN®, is a tiny tube that is to be implanted in the eye and releases low levels of the corticosteroid (fluocinolone acetonide) in the eye. ILUVIEN® delivers corticosteroid directly to the intended site of action for up to 36 months. | Drug | ILUVIEN® 190μg |
Primary outcome
Absence of cystoid macular oedema on Optical Coherence Tomography and a decrease from baseline in vitreous haze grade of ≥2 steps, or absence of vitreous haze.
Time frame: 6 months after administration
The primary endpoint for evaluating the effect of the implant on non-infectious uveitis affecting the posterior segment of the eye will be based on treatment success, determined at 6 months after administration. Treatment success will be determined based on a composite variable defined as Absence of cystoid macular oedema on Optical Coherence Tomography and a decrease from baseline in vitreous haze grade of ≥2 steps, or absence of vitreous haze.
Rate of cataract formation and Rate of IOP elevation
Time frame: 6 months after administration
The primary endpoint for evaluating the safety of the implant on non-infectious uveitis affecting the posterior segment of the eye will be determined. * Rate of cataract formation * Rate of IOP elevation (Change from baseline in IOP and incidence of significant changes in IOP, including: IOP>21 mmHg, IOP>25 mmHg, IOP>30 mmHg, increases from baseline of 10 mmHg or more).
2 secondary outcomes
Changes in vision and incidence of increase in IOP, AE, and uveitis recurrence
Time frame: Every 6 months over 3 years
Incidence of secondary increase in IOP, secondary increase in IOP requiring surgical intervention, and ocular and non-ocular AEs.
Time frame: 3, 6, 12, and 36 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: No
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.
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing fluocinolone acetonide 190 micrograms in people with Non-infectious Uveitis Affecting the Posterior Segment of the Eye, run by Alimera Sciences at 6 sites in 3 countries.
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 4 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: looking for participants now, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Spain, United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Operations (353 (0) 1 553 0215, clinicaltrials@alimerasciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absence of cystoid macular oedema on Optical Coherence Tomography and a decrease from baseline in vitreous haze grade of ≥2 steps, or absence of vitreous haze. (time frame: 6 months after administration). The study lists 2 primary outcomes in all. 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 6 Aug 2024.