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.

Alimera Sciences

Status and phase: Enrolling; Phase 4

Conditions: Non-infectious Uveitis Affecting the Posterior Segment of the Eye

Treatments: Drug: fluocinolone acetonide 190 micrograms

Study type: Interventional

Funder types: Industry

Identifiers

NCT06539481

ALI-P01-21-006

Details and patient eligibility

About

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

Enrollment: 25 estimated patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

ILUVIEN® 190μg

Experimental group

Treatment:

Drug: fluocinolone acetonide 190 micrograms