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.

August 1, 2024 updated by: Alimera Sciences

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ILUVIEN® 190μg
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: 6 months after administration
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
Time Frame: 6 months after administration

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).
6 months after administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in vision and incidence of increase in IOP, AE, and uveitis recurrence
Time Frame: Every 6 months over 3 years
  • 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
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.
Time Frame: 3, 6, 12, and 36 months.

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.
3, 6, 12, and 36 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alimera Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 31, 2024

Primary Completion (Estimated)

July 15, 2026

Study Completion (Estimated)

October 31, 2028

Study Registration Dates

First Submitted

July 30, 2024

First Submitted That Met QC Criteria

August 1, 2024

First Posted (Actual)

August 6, 2024

Study Record Updates

Last Update Posted (Actual)

August 6, 2024

Last Update Submitted That Met QC Criteria

August 1, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALI-P01-21-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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