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A Multicentre Study to Evaluate the Safety and Efficacy of the Eye Implant ILUVIEN® in Children with non-infectious uveitis affecting the posterior segment of the eye
EU CTIS ID: 2023-509469-19-00
What this study is testing
To evaluate safety and efficacy of ILUVIEN® 190μg in paediatric subjects with recurrent non-infectious uveitis affecting the posterior segment of the eye
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Males and females of ≥6 and <18 years of age at time of consent
- Subject is not planning to undergo elective ocular surgery during the trial
- Presence of a signed written informed consent form from the subject or subject's legal representative, and/or a signed info assent from subject in accordance with local legal requirements.
- Non-infectious uveitis affecting the posterior segment of 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
You likely can't join if
- History of intraocular surgery in the study eye within 90 days of the screening visit
- Vitreous haemorrhage
- Intraocular inflammation associated with a condition other than non-infectious uveitis (e.g., intraocular lymphoma)
- Ocular malignancy in either eye, including choroidal melanoma
- Toxoplasmosis scar in study eye; or scar related to previous viral retinitis
- Previous viral retinitis
See the full eligibility criteria
Who can join
- Males and females of ≥6 and <18 years of age at time of consent
- Subject is not planning to undergo elective ocular surgery during the trial
- Presence of a signed written informed consent form from the subject or subject's legal representative, and/or a signed info assent from subject in accordance with local legal requirements.
- Non-infectious uveitis affecting the posterior segment of 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
- The degree of inflammation with anterior chamber cells ≥ Grade 1 and/or vitreous haze of ≥ Grade 1 and/or evidence of macular oedema in the study eye considered to be caused by recurrent uveitis
- Visual acuity of study eye is at least 35 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart
- No evidence of medically unstable systemic disease defined as any systemic disease requiring a change (increase or decrease) in systemic treatment in the 90 days prior to Day 1
- Ability and willingness to comply with the treatment and follow-up procedures
- No expectation that the subject will be moving out of the area of the clinical centre to an area not covered by another clinical centre during the next 36 months
What rules you out
- History of intraocular surgery in the study eye within 90 days of the screening visit
- Vitreous haemorrhage
- Intraocular inflammation associated with a condition other than non-infectious uveitis (e.g., intraocular lymphoma)
- Ocular malignancy in either eye, including choroidal melanoma
- Toxoplasmosis scar in study eye; or scar related to previous viral retinitis
- Previous viral retinitis
- Current viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and mycobacterial infections of the eye or fungal diseases of ocular structure
- Media opacity precluding evaluation of retina and vitreous
- Peripheral retinal detachment and/or vitreoretinal traction in area of area of insertion
- Prior administration of intravitreal Ozurdex within 6 months of the screening visit
- Prior administration of fluocinolone intravitreal implant within 3 years of the screening visit in the study eye
- Hypersensitivity to FA or any component of ILUVIEN
- Viral corneal pathology in the study eye
- Moderate to severe dry eye in the study eye
- Ocular or adnexal infections or infectious uveitis in the study eye
- Chronic hypotony (< 6 mmHg)
- Capsulotomy in study eye within 30 days prior to Day 1
- Subjects requiring chronic systemic or inhaled corticosteroid therapy (>0.15 mg/kg daily) or systemic immunosuppressive therapy for autoimmune conditions other than Juvenile Idiopathic Arthritis, Blau syndrome, Idiopathic Chronic Anterior Uveitis, Intermediate Uveitis, Idiopathic Panuveitis
- History of certain skin cancers (specifically, basal cell carcinoma and squamous cell carcinoma), any malignancy receiving treatment, or in remission less than 5 years prior to Day 1
- Systemic infection within 30 days prior to Day 1
- Any severe acute or chronic medical or psychiatric condition that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the Investigator, could make the subject inappropriate for entry into this study
- Any other systemic or ocular condition which, in the judgment of the Investigator, could make the subject inappropriate for entry into this study
- History of any form of glaucoma or ocular hypertension in study eye, unless study eye has been previously treated with an incisional IOPlowering 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))
- Treatment with an investigational drug or device within 3 months prior to Day 1
- Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol from at least 14 days prior to study Day 1 until the End of Study (Month 36).
- Any persons with a dependent relationship to the sponsor, the investigational site or the Investigator.
- Any persons held in an institution by a government or judicial order.
- 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
- Best corrected visual acuity (BCVA) < 20/200 in the study eye at screening and Day 1
- History of posterior uveitis only that was not accompanied by vitritis or macular oedema
- History of iritis only and no vitreous cells, anterior chamber cells (ACC), or vitreous haze
- Uveitis with infectious aetiology
- Mycobacterial uveitis or chorioretinal changes of either eye which, in the opinion of the Investigator, resulted from infectious mycobacterial uveitis
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.