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    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2022-001622-29
    Sponsor's Protocol Code Number:ALI-P01-21-006
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-11-22
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2022-001622-29
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    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
    A.4.1Sponsor's protocol code numberALI-P01-21-006
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/442/2021
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAlimera Sciences Europe Limited
    B.1.3.4CountryIreland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAlimera Sciences Europe Limited
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAMS Advanced Medical Services GmbH
    B.5.2Functional name of contact pointProject Management
    B.5.3 Address:
    B.5.3.1Street AddressAm Exerzierplatz 2
    B.5.3.2Town/ cityMannheim
    B.5.3.3Post codeD-68167
    B.5.3.4CountryGermany
    B.5.4Telephone number+4962170095100
    B.5.5Fax number+4962170095140
    B.5.6E-mailoperations@ams-europe.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name ILUVIEN 190 micrograms intravitreal implant in applicator
    D.2.1.1.2Name of the Marketing Authorisation holderALIMERA SCIENCES EUROPE LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameILUVIEN 190 micrograms intravitreal implant in applicator
    D.3.4Pharmaceutical form Intravitreal implant in applicator
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravitreal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFluocinolone acetonide
    D.3.9.1CAS number 67-73-2
    D.3.9.2Current sponsor codeALI-P01-21-006
    D.3.9.3Other descriptive nameILUVIEN
    D.3.9.4EV Substance CodeSUB07714MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number190
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Non-Infectious Uveitis affecting the posterior segment
    E.1.1.1Medical condition in easily understood language
    Non-Infectious Uveitis affecting the posterior segment
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10036370
    E.1.2Term Posterior uveitis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate safety and efficacy of ILUVIEN® 190µg in paediatric subjects with recurrent non-infectious uveitis affecting the posterior segment of the eye
    E.2.2Secondary objectives of the trial
    1. To assess the incidence of recurrence of non-infectious uveitis affecting the posterior segment in the study eye
    2. To evaluate the incidence and onset of secondary lens opacity and extraction
    3. To assess the incidence of secondary intraocular pressure (IOP) elevation
    E.2.3Trial contains a sub-study No
    E.3Principal 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.
    E.4Principal 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 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).
    32. Any persons with a dependent relationship to the sponsor, the investigational site or the Investigator.
    33. Any persons held in an institution by a government or judicial order.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoints:

    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

    Primary Safety Endpoints:
    • 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).
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints
    1. 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
    2. Uveitis recurrence rate following treatment, compared to the uveitis recurrence rate over the 12 months prior to enrolment
    3. 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
    4. The time to recurrence of non-infectious uveitis affecting the posterior segment in the study eye
    5. Change in macular oedema
    6. Change in Best Corrected Visual Acuity
    7. Change in vitreous haze
    8. Change in anterior chamber cell grade
    9. Incidence of secondary increase in IOP
    10. Incidence of secondary increase in IOP requiring surgical intervention
    11. Incidence and onset of secondary lens opacity and extraction
    12. Number of adjunctive treatments required to treat recurrences of uveitis
    13. Presence of active chorioretinal and retinal vascular lesions
    14. Incidence of ocular infection
    15. Change from baseline in cup-to-disc ratio
    16. Incidence of ocular and non-ocular adverse events (AEs)

    Secondary Safety Endpoints:
    • Incidence of secondary increase in IOP
    • Incidence of secondary increase in IOP requiring surgical intervention
    • Incidence of ocular and non-ocular AEs.
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 years
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United Kingdom
    European Union
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last patient Last Visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 25
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 12
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 13
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 25
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients will remain under the care of their physician and receive the standard care treatment regime for that institution
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2023-04-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-01-24
    P. End of Trial
    P.End of Trial StatusOngoing
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