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    Summary
    EudraCT Number:2016-002523-28
    Sponsor's Protocol Code Number:KHAK1001
    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:2016-07-05
    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 number2016-002523-28
    A.3Full title of the trial
    A Pilot Study Evaluating the Effect of Intravitreal Fluocinolone Acetonide (0.19mg) in Patients with Retinitis Pigmentosa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Pilot Study Evaluating the Effect of Intravitreal Fluocinolone Acetonide (0.19mg) in Patients with Retinitis Pigmentosa.
    A.3.2Name or abbreviated title of the trial where available
    Iluvien for IRD
    A.4.1Sponsor's protocol code numberKHAK1001
    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 SponsorMoorfields Eye Hospital
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAlimera Sciences
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMoorfields Eye Hospital
    B.5.2Functional name of contact pointNatasha Ajraam, R&D
    B.5.3 Address:
    B.5.3.1Street Address162 City Road
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeEC1V 2PD
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailnatasha.ajraam@moorfields.nhs.uk
    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 Ltd.
    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 nameIluvien
    D.3.2Product code n/a
    D.3.4Pharmaceutical form Implant
    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 CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number 0.19
    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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Retinitis Pigmetosa.
    E.1.1.1Medical condition in easily understood language
    Inherited form of eye disease.
    E.1.1.2Therapeutic area Body processes [G] - Genetic Phenomena [G05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10038914
    E.1.2Term Retinitis pigmentosa
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To describe the anatomical and functional changes occurring in treated and control eyes over a 36-month period.

    Technical outcome measures =
    OCT: (1) Change in area of ellipsoid zone integrity (mm2) at the macula. (2) Change in outer retinal thickness across the macula. (3) Change in subfoveal choroidal thickness (mm).
    FAF: (1) Change in area demonstrating “loss of AF” on standard 55° macula centred image (mm2). (2) Area within the ring of hyperautofluorescence (mm2).
    Visual Field: Change in size of V4e isopter area.



    E.2.2Secondary objectives of the trial
    1. To describe further anatomical and functional changes occurring in treated and control eyes over 36 months.

    Technical outcome measures =
    Retinal Oximetry: Change in oxygen saturation and vessel calibre in retinal venules and arterioles taken at predetermined retinal loci.
    ERG: Change in all ISCEV electrophysiological parameters - PERG amplitude (P50, N95), rod-specific B wave amplitude, FFERG A and B wave amplitudes and timing, 30Hz flicker amplitude and latency, extent of multifocal ERG change. The hand-held ERG (RETeval) will be used to monitor 30Hz flicker.
    Microperimetry: Change in mesopic and scotopic threshold sensitivities at predetermined retinal loci. Change in area under the “hill of vision”.
    Adaptive optics slit lamp ophthalmoscopy: Change in photoreceptor outer segment morphology (Cone density, ratio of hexagonal Voronoi domain, and average nearest neighbour distance (NND)/expected NND - mean value of two independent graders).

    2. To study the safety profile
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adult patients with retinitis pigmentosa and signs of intraocular inflammation (vitreous cells, cataract, epiretinal membrane, intraretinal oedema, clinically significant migration of pigment cells into the retina‎‎).
    E.4Principal exclusion criteria
    1. Patients in whom Fluocinolone Acetonide is contraindicated (prior infectious eye disease, glaucoma or ‎steroid induced ocular hypertension). ‎
    ‎2.‎ Patients with a clinically apparent asymmetric expression of their retinopathy (as determined by an experienced retina physician).‎
    ‎3.‎ High ametropia (greater than ±6D) to avoid complications of cataract surgery should it be ‎necessary.‎
    ‎4.‎ Patients with planned intraocular surgery within the study period.‎
    5. Patients with dense cataract precluding adequate fundus imaging.
    6. Female patients who are pregnant or breastfeeding. Female patients of child-bearing age should ensure an adequate contraceptive measure is used.
    7. Patients known to require other forms of systemic immunosuppression within the study period.

    E.5 End points
    E.5.1Primary end point(s)
    Primary Outcome measures:
    OCT: (1) Change in area of ellipsoid zone integrity (mm2) at the macula. (2) Change in outer retinal thickness across the macula. (3) Change in subfoveal choroidal thickness (mm).
    FAF: (1) Change in area demonstrating “loss of AF” on standard 55 degree macula centred image (mm2). (2) Area within the ring of hyperautofluorescence (outer edge taken as the limit if a broad band).
    Visual Field: Change in size of V4e isopter area over 36 months.





    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline (month 0)
    Week 2 (safety check of intraocular pressure)
    Month 4
    Month 8
    Month 12
    Month 24
    Month 36
    E.5.2Secondary end point(s)
    Retinal Oximetry: Change in oxygen saturation and vessel calibre in retinal venules and arterioles taken at predetermined retinal loci.
    ERG: Change in all ISCEV electrophysiological parameters - PERG amplitude (P50, N95), rod-specific B wave amplitude, FFERG A and B wave amplitudes and timing, 30Hz flicker amplitude and latency, extent of multifocal ERG change. The hand-held ERG (RETeval) will be used to monitor 30Hz flicker.
    Microperimetry: Change in mesopic and scotopic threshold sensitivities at predetermined retinal loci. Change in area under the “hill of vision”.
    Adaptive optics slit lamp ophthalmoscopy: Change in photoreceptor outer segment morphology (Cone density, ratio of hexagonal Voronoi domain, and average nearest neighbour distance (NND)/expected NND - mean value of two independent graders).

    The safety profile over 36 months of an intravitreal steroid implant (Fluocinolone Acetonide, 0.19mg) in adult patients with retinitis pigmentosa.
    Outcome measures: Number of cases requiring treatment for either (a) ocular hypertension or glaucoma, (b) cataract or (c) posterior segment disease (retinal detachment, tear or endophthalmitis).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline (month 0)
    Week 2 (safety check of intraocular pressure)
    Month 4
    Month 8
    Month 12
    Month 24
    Month 36
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 Yes
    E.8.1.7.1Other trial design description
    control is the fellow (untreated) eye
    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
    fellow (untreated) eye
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    The last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months10
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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.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)
    Until the drug is licensed for treatment of RP, the patients will not be offered Iluvien injection on the NHS.

    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-07-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-10-20
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