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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ILUVIEN® 190μg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluocinolone acetonide 190 micrograms | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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.
| 6 months after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in vision and incidence of increase in IOP, AE, and uveitis recurrence |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Contact | 353 (0) 1 553 0215 | clinicaltrials@alimerasciences.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité - Universitätsmedizin Berlin Institute of Health Department of Ophthalmology | Not yet recruiting | Berlin | Germany |
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|
| 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
| 3, 6, 12, and 36 months. |
| Augenzentrum am St. Franziskus-Hospital Münster | Recruiting | Münster | Germany |
|
| Hospital Universitario Cruces | Recruiting | Bilbao | Spain |
|
| Fundación Jiménez Díaz | Recruiting | Madrid | Spain |
|
| University of Bristol Bristol Medical School | Recruiting | Bristol | United Kingdom |
|
| Sheffield Teaching Hospitals NHS Foundation Trust and Sheffield Children NHS Foundation Trust | Recruiting | Sheffield | United Kingdom |
|