Fluocinolone acetonide for Non-infectious uveitis affecting the posterior segment

Inclusion criteria

• {"criterion_text":"-Males and females of ≥6 and <18 years of age at time of consent"}
• {"criterion_text":"-Subject is not planning to undergo elective ocular surgery during the trial"}
• {"criterion_text":"-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."}
• {"criterion_text":"-Non-infectious uveitis affecting the posterior segment of the study eye with a history of recurrence ≥1 per year as assessed by the Investigator"}
• {"criterion_text":"-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"}
• {"criterion_text":"-Treatment with systemic corticosteroid or other systemic therapies given for at least 3 months within the previous 12 months prior to Day 1"}
• {"criterion_text":"-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"}
• {"criterion_text":"-Visual acuity of study eye is at least 35 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart"}
• {"criterion_text":"-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"}
• {"criterion_text":"-Ability and willingness to comply with the treatment and follow-up procedures"}
• {"criterion_text":"-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"}

Exclusion criteria

• {"criterion_text":"-History of intraocular surgery in the study eye within 90 days of the screening visit"}
• {"criterion_text":"-Vitreous haemorrhage"}
• {"criterion_text":"-Intraocular inflammation associated with a condition other than non-infectious uveitis (e.g., intraocular lymphoma)"}
• {"criterion_text":"-Ocular malignancy in either eye, including choroidal melanoma"}
• {"criterion_text":"-Toxoplasmosis scar in study eye; or scar related to previous viral retinitis"}
• {"criterion_text":"-Previous viral retinitis"}
• {"criterion_text":"-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"}
• {"criterion_text":"-Media opacity precluding evaluation of retina and vitreous"}
• {"criterion_text":"-Peripheral retinal detachment and/or vitreoretinal traction in area of area of insertion"}
• {"criterion_text":"-Prior administration of intravitreal Ozurdex within 6 months of the screening visit"}
• {"criterion_text":"-Prior administration of fluocinolone intravitreal implant within 3 years of the screening visit in the study eye"}
• {"criterion_text":"-Hypersensitivity to FA or any component of ILUVIEN"}
• {"criterion_text":"-Viral corneal pathology in the study eye"}
• {"criterion_text":"-Moderate to severe dry eye in the study eye"}
• {"criterion_text":"-Ocular or adnexal infections or infectious uveitis in the study eye"}
• {"criterion_text":"-Chronic hypotony (< 6 mmHg)"}
• {"criterion_text":"-Capsulotomy in study eye within 30 days prior to Day 1"}
• {"criterion_text":"-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"}
• {"criterion_text":"-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"}
• {"criterion_text":"-Systemic infection within 30 days prior to Day 1"}
• {"criterion_text":"-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"}
• {"criterion_text":"-Any other systemic or ocular condition which, in the judgment of the Investigator, could make the subject inappropriate for entry into this study"}
• {"criterion_text":"-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))"}
• {"criterion_text":"-Treatment with an investigational drug or device within 3 months prior to Day 1"}
• {"criterion_text":"-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)."}
• {"criterion_text":"-Any persons with a dependent relationship to the sponsor, the investigational site or the Investigator."}
• {"criterion_text":"-Any persons held in an institution by a government or judicial order."}
• {"criterion_text":"-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"}
• {"criterion_text":"-Best corrected visual acuity (BCVA) < 20/200 in the study eye at screening and Day 1"}
• {"criterion_text":"-History of posterior uveitis only that was not accompanied by vitritis or macular oedema"}
• {"criterion_text":"-History of iritis only and no vitreous cells, anterior chamber cells (ACC), or vitreous haze"}
• {"criterion_text":"-Uveitis with infectious aetiology"}
• {"criterion_text":"-Mycobacterial uveitis or chorioretinal changes of either eye which, in the opinion of the Investigator, resulted from infectious mycobacterial uveitis"}

Primary endpoints

• {"endpoint_text":"-Treatment success based on: 1. Absence of cystoid macular oedema on Optical Coherence Tomography AND 2. A decrease from baseline in vitreous haze grade ≥2 steps, or absence of vitreous haze","definition_or_measurement_approach":"Assessment by Optical Coherence Tomography for cystoid macular oedema; vitreous haze graded and compared to baseline (≥2 step decrease) or absence of vitreous haze"}
• {"endpoint_text":"-Rate of cataract formation","definition_or_measurement_approach":"Incidence (rate) of cataract formation assessed during study follow-up; timing/onset also captured as per study visits"}
• {"endpoint_text":"-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).","definition_or_measurement_approach":"Intraocular pressure measured and change from baseline calculated; incidence thresholds include IOP>21, >25, >30 mmHg and increases from baseline ≥10 mmHg"}

Secondary endpoints

• {"endpoint_text":"-Absence of cystoid macular oedema and decrease from baseline in vitreous haze grade of ≥2 steps, or absence of vitreous haze at completion of the study","definition_or_measurement_approach":"OCT for macular oedema; vitreous haze grading compared to baseline at study completion"}
• {"endpoint_text":"-Uveitis recurrence rate following treatment, compared to the uveitis recurrence rate over the 12 months prior to enrolment","definition_or_measurement_approach":"Compare recurrence rate post-treatment to baseline 12-month pre-enrolment recurrence rate as recorded in medical history"}
• {"endpoint_text":"-The incidence of recurrence of non-infectious uveitis affecting the posterior segment in the study eye and in the fellow eye after receiving study treatment","definition_or_measurement_approach":"Incidence of recurrence recorded for study eye and fellow eye during follow-up"}
• {"endpoint_text":"-The time to recurrence of non-infectious uveitis affecting the posterior segment in the study eye","definition_or_measurement_approach":"Time-from-treatment to first recurrence event in study eye"}
• {"endpoint_text":"-Change in macular oedema","definition_or_measurement_approach":"Change measured by OCT relative to baseline"}
• {"endpoint_text":"-Change in Best Corrected Visual Acuity","definition_or_measurement_approach":"Change in BCVA measured (e.g., ETDRS letters) from baseline"}
• {"endpoint_text":"-Change in vitreous haze","definition_or_measurement_approach":"Change in vitreous haze grade from baseline"}
• {"endpoint_text":"-Change in anterior chamber cell grade","definition_or_measurement_approach":"Change in anterior chamber cell grade from baseline"}
• {"endpoint_text":"-Incidence of secondary increase in IOP","definition_or_measurement_approach":"Incidence of IOP increases recorded during follow-up"}
• {"endpoint_text":"-Incidence of secondary increase in IOP requiring surgical intervention","definition_or_measurement_approach":"Incidence of IOP increases that necessitate surgical intervention"}
• {"endpoint_text":"-Incidence and onset of secondary lens opacity and extraction","definition_or_measurement_approach":"Incidence and timing of lens opacity/cataract and surgical extraction recorded"}
• {"endpoint_text":"-Number of adjunctive treatments required to treat recurrences of uveitis","definition_or_measurement_approach":"Count of adjunctive treatments used to manage recurrence events"}
• {"endpoint_text":"-Presence of active chorioretinal and retinal vascular lesions","definition_or_measurement_approach":"Clinical/retinal imaging assessment for active lesions"}
• {"endpoint_text":"-Incidence of ocular infection","definition_or_measurement_approach":"Incidence of ocular infections recorded as adverse events"}
• {"endpoint_text":"-Change from baseline in cup-to-disc ratio","definition_or_measurement_approach":"Change in cup-to-disc ratio measured from baseline"}
• {"endpoint_text":"-Incidence of ocular and non-ocular adverse events (AEs)","definition_or_measurement_approach":"Recording and classification of all ocular and non-ocular AEs during study"}

Germany

Earliest CTIS Part Ii Submission Date

12-04-2024

Latest Decision Or Authorization Date

29-04-2026

Processing Time Days

747

Number Of Sites

2

Number Of Participants

5

Spain

Earliest CTIS Part Ii Submission Date

12-04-2024

Latest Decision Or Authorization Date

30-04-2026

Processing Time Days

748

Number Of Sites

2

Number Of Participants

5

Primary sponsor

Full Name

Alimera Sciences Europe Limited

Organisation Type

Pharmaceutical company

Country Of Registered Address

Ireland

Contract research organisations

Name

Primevigilance Limited

Responsibilities

sponsorDuties codes: 8 (see third parties entry); contact email SafetyAlimera@primevigilance.com

Name

AMS Advanced Medical Services GmbH

Responsibilities

sponsorDuties codes: 1,10,11,12,2,6,7 (see third parties entry); contact email operations@ams-europe.com

Third parties

• {"country":"United Kingdom","full_name":"Primevigilance Limited","duties_or_roles":"codes: 8","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"AMS Advanced Medical Services GmbH","duties_or_roles":"codes: 1,10,11,12,2,6,7","organisation_type":"Pharmaceutical company"}