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    Summary
    EudraCT Number:2013-001810-14
    Sponsor's Protocol Code Number:PSV-FAI-001
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-08-19
    Trial results View 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 ConcernedUK - MHRA
    A.2EudraCT number2013-001810-14
    A.3Full title of the trial
    A PHASE III, MULTI-NATIONAL, MULTI-CENTER, RANDOMIZED, MASKED, CONTROLLED, SAFETY AND EFFICACY STUDY OF A FLUOCINOLONE ACETONIDE INTRAVITREAL (FAI) INSERT IN SUBJECTS WITH CHRONIC 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 clinical study of the FAI Insert in patients with uveitis in the back of the eye that is not caused by an infection
    A.4.1Sponsor's protocol code numberPSV-FAI-001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01694186
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorpSivida Corporation
    B.1.3.4CountryUnited States
    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 supportpSivida Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationpSivida Corporation
    B.5.2Functional name of contact pointClinical Information
    B.5.3 Address:
    B.5.3.1Street Address480 Pleasant Street
    B.5.3.2Town/ cityWatertown
    B.5.3.3Post codeMA 02472
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1617972-6350
    B.5.5Fax number+1617926-5050
    B.5.6E-mailclinical.info@psivida.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
    D.2.1.1.2Name of the Marketing Authorisation holderAlimera Sciences Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameFluocinolone Acetonide Intravitreal insert
    D.3.2Product code FAI insert
    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.3.9.4EV Substance CodeSUB07714MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.18
    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
    chronic non-infectious uveitis affecting the posterior segment of the eye
    E.1.1.1Medical condition in easily understood language
    Uveitis in the back of the eye that is not caused by an infection
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10046851
    E.1.2Term Uveitis
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objectives of this study are to evaluate the safety and efficacy of a FAI insert in the management of subjects with chronic non-infectious uveitis affecting the posterior segment of the eye.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or non-pregnant female at least 18 years of age at time of consent
    • One or both eyes having a history of recurrent non-infectious uveitis affecting the posterior segment of the eye with or without anterior uveitis > 1 year duration.
    • During the 12 months prior to enrollment (Day 1), the study eye has either received treatment:
    o systemic corticosteroid or other systemic therapies given for at least 3 months, and/or
    o at least 2 intra- or peri-ocular injections of corticosteroid for management of uveitis
    OR the study eye has experienced recurrence:
    o at least 2 separate recurrences of uveitis requiring systemic, intra- or peri-ocular injection of corticosteroid
    • At the time of enrollment (Day1), study eye has < 10 anterior chamber cells/HPF and a vitreous haze ≤ grade 2.
    • Visual acuity of study eye is at least 15 letters on the ETDRS chart
    • Subject is not planning to undergo elective ocular surgery during the study
    • Subject has ability to understand and sign the Informed Consent Form
    • Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
    E.4Principal exclusion criteria
    • Allergy to fluocinolone acetonide or any component of the FAI insert
    • History of posterior uveitis only that is not accompanied by vitritis or macular edema
    • History of iritis only and no vitreous cells, anterior chamber cells or vitreous haze
    • Uveitis with infectious etiology
    • Vitreous hemorrhage
    • Intraocular inflammation associated with a condition other than noninfectious 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, and varicella, mycobacterial infections of the eye or fungal diseases of ocular structure
    • Media opacity precluding evaluation of retina and vitreous
    • Peripheral retinal detachment in area of insertion
    • Diagnosis of any form of glaucoma or ocular hypertension in study eye at Screening, unless study eye has been previously treated with an incisional surgery procedure that has resulted in stable IOP in the normal range (10-20 mmHG) at Screening
    • Intraocular pressure (IOP) > 21 mmHg or concurrent therapy at screening with any IOP-lowering pharmacologic agent in the study eye
    • Chronic hypotony (< 6 mmHg)
    • Ocular surgery on the study eye within 3 months prior to study Day 1
    • Capsulotomy in study eye within 30 days prior to study Day 1
    • Prior intravitreal treatment of study eye with Retisert within 36 months prior to study Day 1
    • Prior intravitreal treatment of study eye with Ozurdex within 6 months prior to study Day 1
    • Prior intravitreal treatment of study eye with Triesence or Trivaris within 3 months prior to study Day 1
    • Prior peri-ocular or subtenon steroid treatment of study eye within 3 months prior to study Day 1
    • Subjects requiring chronic systemic or inhaled corticosteroid therapy (>15mg prednisone daily) or chronic systemic immunosuppressive therapy
    • Excluding certain skin cancers (specifically, basal cell carcinoma and squamous cell carcinoma), any malignancy receiving treatment, or in remission less than 5 years prior to study Day 1
    •Subjects who test positive for human immune deficiency virus (HIV) or syphilis during screening
    •Mycobacterial uveitis or chorio-retinal changes of either eye which, in the opinion of the Investigator, result from infectious mycobacterial uveitis
    • Systemic infection within 30 days prior to study 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
    • Treatment with an investigational drug or device within 30 days prior to study 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 Month 12 Visit
    • Subjects unlikely to comply with the study protocol or who are likely to be lost to follow-up within three years
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy:
    Proportion of subjects who have a recurrence of uveitis in the study eye within 6 months after receiving study treatment.
    Recurrence is defined as:
    • A > 2 step increase in the number of cells in the anterior chamber per high powered field (1.6 X using a 1-mm beam), compared to any visit time point prior to Month 6
    OR
    • An increase in the vitreous haze of > 2 steps, compared to any visit time point prior to Month 6
    OR
    • A deterioration in visual acuity of at least 15 letters BCVA, compared to any visit time point prior to Month 6

    Safety:
    • Systemic adverse events
    • Ocular adverse events, including IOP elevation; medications/procedures required to control elevated IOP; development or worsening of cataract; cataract-related procedures; clinically significant ocular changes; procedure related adverse events
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months after receiving study treatment
    E.5.2Secondary end point(s)
    Exploratory Efficacy Endpoints:
    • Proportion of subjects who have a recurrence of uveitis in the study eye within 12 months or 36 months
    • Proportion of subjects who have a recurrence of uveitis in the fellow eye (within 6 months, 12 months and 36 months)
    • Mean change from baseline in BCVA letter score in the study eye (at 6 months, 12 months and 36 months)
    • Number of recurrences of uveitis (within 6 months, 12 months and 36 months)
    • Time to recurrence of uveitis (within 6 months, 2 months and 36 months)
    • Number of adjunctive treatments required to treat recurrences of uveitis (within 6 months, 12 months and 36 months)
    • Resolution of macular edema, as measured by OCT imaging (at 6 months, 12 months and 36 months)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Within 6, 12 and/or 36 months after receiving study treatment
    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 Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3.1Comparator description
    Sham Injection
    E.8.2.4Number of treatment arms in the trial2
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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
    Germany
    Hungary
    India
    Israel
    Italy
    Turkey
    United Kingdom
    United States
    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
    LVLS
    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 months3
    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 months6
    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 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 120
    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)
    The sponsor is considering the possibility of offering subjects who complete PSV-FAI-001 additional treatment with the FAI insert, in the study eye, the fellow eye or both eyes, depending upon the disease status of the subject's eyes. The company will make a decision in the future concerning this possible additional study, based on many factors, including the efficacy and safety of the FAI insert observed in PSV-FAI-001
    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 Decision2013-09-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-03-26
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