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.

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• Uveitis 299

Uveitis

299 studies on the registry are indexed under Uveitis; 32 are open to participants now.

This study's planned enrollment of 25 is below the median of 30 across 175 interventional studies indexed under Uveitis.

Lead sponsor

Alimera Sciences is the lead sponsor of 12 studies on the registry; 1 is open to participants now.

Study arms

• Experimental
  ILUVIEN® 190μg

  Drug: fluocinolone acetonide 190 micrograms

Interventions

• Drugfluocinolone acetonide 190 micrograms

  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.

Primary outcomes

1. 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.

   Time frame: 6 months after administration

2. 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).

   Time frame: 6 months after administration

Secondary outcomes

1. 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

   Time frame: Every 6 months over 3 years

2. 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.

   Time frame: 3, 6, 12, and 36 months.

Individual participant data

Plan to share: No