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. The treatment will be considered successful if two things happen: 1. No swelling in the back of the eye called cystoid macular oedema; 2. 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: 1. 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. 2. Be followed for 36 months for checkups and tests
• 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