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

Phase 1

• Conditions: on-Infectious Uveitis affecting the posterior segment; MedDRA version: 20.1Level: LLTClassification code 10036370Term: Posterior uveitisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2022-001622-29-DE
• Lead Sponsor: Alimera Sciences Europe Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-22
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1.Males and females of =6 and <18 years of age at time of consent
2.Non-infectious posterior, intermediate or panuveitis in the study eye with a history of recurrence =1 per year as assessed by the Investigator
3.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
4.Treatment with systemic corticosteroid or other systemic therapies given for at least 3 months within the previous 12 months prior to Day 1
5.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
6.Visual acuity of study eye is at least 35 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart
7.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
8.Ability and willingness to comply with the treatment and follow-up procedures
9.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
10.Subject is not planning to undergo elective ocular surgery during the trial
11.Presence of a signed written informed consent form from the subject or subject’s legal representative, and/or a signed informed assent from subject in accordance with local legal requirements.

Are the trial subjects under 18? yes
Number of subjects for this age range: 25
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.History of intraocular surgery in the study eye within 90 days of the screening visit
2.Hypersensitivity to FA or any component of ILUVIEN®
3.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))
4.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
5.Best corrected visual acuity (BCVA) < 20/200 in the study eye at screening and Day 1
6.History of posterior uveitis only that was not accompanied by vitritis or macular oedema
7.History of iritis only and no vitreous cells, anterior chamber cells (ACC), or vitreous haze
8.Uveitis with infectious aetiology
9.Mycobacterial uveitis or chorioretinal changes of either eye which, in the opinion of the Investigator, resulted from infectious mycobacterial uveitis
10.Vitreous haemorrhage
11.Intraocular inflammation associated with a condition other than non-infectious uveitis (e.g., intraocular lymphoma)
12.Ocular malignancy in either eye, including choroidal melanoma
13.Toxoplasmosis scar in study eye; or scar related to previous viral retinitis
14.Previous viral retinitis
15.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
16.Media opacity precluding evaluation of retina and vitreous
17.Peripheral retinal detachment and/or vitreoretinal traction in area of area of insertion
18.Prior administration of intravitreal Ozurdex within 6 months of the screening visit
19.Prior administration of fluocinolone intravitreal implant within 3 years of the screening visit in the study eye
20.Viral corneal pathology in the study eye
21.Moderate to severe dry eye in the study eye
22.Ocular or adnexal infections or infectious uveitis in the study eye
23.Chronic hypotony (< 6 mmHg)
24.Capsulotomy in study eye within 30 days prior to Day 1
25.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
26.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
27.Systemic infection within 30 days prior to Day 1
28.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
29.Any other systemic or ocular condition which, in the judgment of the Investigator, could make the subject inappropriate for entry into this study
30.Treatment with an investigational drug or device within 3 months prior to Day 1
31.Pregnant or nursing females; females of child

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified