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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.

NCT06539481 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-08-06

No results posted yet for this study

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.

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

Conditions

  • Non-infectious Uveitis Affecting the Posterior Segment of the Eye

Interventions

DRUG

fluocinolone 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.

Sponsors & Collaborators

  • Alimera Sciences

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-31
Primary Completion
2026-07-15
Completion
2028-10-31

Countries

  • Germany
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06539481 on ClinicalTrials.gov