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    The EU Clinical Trials Register currently displays   43801   clinical trials with a EudraCT protocol, of which   7264   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:2015-003723-65
    Sponsor's Protocol Code Number:MICM1014
    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:2016-01-06
    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 number2015-003723-65
    A.3Full title of the trial
    Aflibercept (Eylea®) for macular oedema associated with underlying Retinitis Pigmentosa (AMOUR)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prospective non-randomised pilot study looking at the safety and efficacy of a drug called Eylea for patients with an eye condition called Retinitis Pigmentosa, that also have swelling at the back of the eye
    A.3.2Name or abbreviated title of the trial where available
    AMOUR
    A.4.1Sponsor's protocol code numberMICM1014
    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 supportBayer plc
    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 pointGisela Barreto
    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.5.4Telephone number02072533411
    B.5.6E-mailgisela.barreto@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 Eylea
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Pharma AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameEylea
    D.3.2Product code n/a
    D.3.4Pharmaceutical form Solution for injection
    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 INNAflibercept
    D.3.9.1CAS number 862111-32-8
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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) Yes
    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 Yes
    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 Pigmentosa associated Cystoid Macular Oedema
    E.1.1.1Medical condition in easily understood language
    Retinitis Pigmentosa in an inherited retinal degenerative eye disorder that causes progressive loss of vision. It can also cause swelling at the back of the eye that affects central vision.
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    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
    To report mean Central Macular Thickness (CMT) at 6 and 12 months as measured with SDOCT in eyes of patients with Retinitis Pigmentosa associated with cystoid macular oedema treated with three loading doses of Eylea at monthly intervals followed by a treat and extend protocol between baseline and twelve months.
    E.2.2Secondary objectives of the trial
    To report mean change in Central Macular Thickness (CMT) as measured with SDOCT in eyes of patients with Retinitis Pigmentosa associated with cystoid macular oedema treated with three loading doses of Eylea at monthly intervals followed by a treat and extend protocol at between baseline and six months, and baseline and twelve months.

    To report the mean BCVA ETDRS letter score at 6 and 12 months in eyes of patients with Retinitis Pigmentosa associated with cystoid macular oedema treated with three loading doses of Eylea at monthly intervals followed by a treat and extend protocol between baseline and twelve months.

    To report the mean change in BCVA ETDRS letter score in eyes of patients with Retinitis Pigmentosa associated with cystoid macular oedema treated with three loading doses of Eylea at monthly intervals followed by a treat and extend protocol between baseline and six months, and baseline and twelve months.

    To report mean macular volume at 6 and 12 months as measured wi
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) At least 16 years of age
    2) Unilateral or Bilateral CMO (the worse eye only will be treated – defined as the eye with a greater central macular thickness (CMT) on OCT)
    3) No previous oral treatment for CMO for last 3 months
    4) No previous peribulbar or intravitreal treatment for CMO in the study eye for last 3 months
    5) No previous topical treatment for CMO in the study eye for last 1 month
    6) Central visual impairment that in the view of the Principal Investigator is due to CMO
    7) BCVA better than 3/60.
    E.4Principal exclusion criteria
    1) Insufficient patient cooperation or media clarity to allow adequate fundus imaging
    2) Evidence of visually significant vitreo-retinal traction or epiretinal membrane on OCT that in the Principal Investigator’s opinion is highly likely to significantly limit the efficacy of intravitreal therapy
    3) History of cataract surgery within prior 3 months or cataract surgery anticipated within 6 months of starting the study
    4) Any anti-VEGF treatment to study eye within 3 months
    5) History of YAG capsulotomy performed within 3 months
    6) Uncontrolled IOP > = 24 mmHg for ocular hypertension (on topical IOP lowering medications)
    7) Advanced glaucoma (in the opinion of a glaucoma specialist)
    8) Patients with active or suspected ocular or periocular infections
    9) Patients with active severe intraocular inflammation
    10) Patients with a new, untreated retinal tear or detachment,
    11) Patients with a stage 3 or 4 macular hole
    12) Thromboembolic event (MI/CVA/Unstable Angina) within 6 months
    13) Pregnancy or family planned within 15 months
    14) Females who are breast feeding
    15) Known allergy or hypersensitivity to anti-VEGF products
    E.5 End points
    E.5.1Primary end point(s)
    To report mean Central Macular Thickness (CMT) at 12 months as measured with SDOCT in eyes of patients with Retinitis Pigmentosa associated with cystoid macular oedema treated with three loading doses of Eylea at monthly intervals followed by a treat and extend protocol between baseline and six months and baseline and twelve months.
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 days following the last visit of the last recruited patient in the study. The last visit of the last recruited patient in the study is defined as 12 months after they received their first intravitreal injection of Eylea.
    E.5.2Secondary end point(s)
    To report mean Central Macular Thickness (CMT) at 6 months as measured with SDOCT in eyes of patients with Retinitis Pigmentosa associated with cystoid macular oedema treated with three loading doses of Eylea at monthly intervals followed by a treat and extend protocol between baseline and six months, and baseline and twelve months.

    To report mean change in Central Macular Thickness (CMT) as measured with SDOCT in eyes of patients with Retinitis Pigmentosa associated with cystoid macular oedema treated with three loading doses of Eylea at monthly intervals followed by a treat and extend protocol between baseline and six months, and baseline and twelve months.

    To report the mean BCVA ETDRS letter score at 6 and 12 months in eyes of patients with Retinitis Pigmentosa associated with cystoid macular oedema treated with three loading doses of Eylea at monthly intervals followed by a treat and extend protocol between baseline and six months and baseline and twelve months.

    To report the mean change in BCVA ETDRS letter score in eyes of patients with Retinitis Pigmentosa associated with cystoid macular oedema treated with three loading doses of Eylea at monthly intervals followed by a treat and extend protocol between baseline and six months, and baseline and twelve months.

    To report mean macular volume at 6 and 12 months as measured with SDOCT in eyes of patients with Retinitis Pigmentosa associated with cystoid macular oedema treated with three loading doses of Eylea at monthly intervals followed by a treat and extend protocol between baseline and six months and baseline and twelve months.

    To report mean change in macular volume as measured with SDOCT in eyes of patients with Retinitis Pigmentosa associated with cystoid macular oedema treated with three loading doses of Eylea at monthly intervals followed by a treat and extend protocol between baseline and six months, and baseline and twelve months.

    To report all AEs and SAEs at any time point during the 12 month study of using intravitreal Eylea in eyes of patients with Retinitis Pigmentosa associated with cystoid macular oedema.

    To report the mean retinal sensitivity at 6 and 12 months using Microperimetry in eyes of patients with Retinitis Pigmentosa associated with cystoid macular oedema treated with three loading doses of Eylea at monthly intervals followed by a treat and extend protocol between baseline and six months and basleine and twelve months.

    To report the mean change in retinal sensitivity using Microperimetry in eyes of patients with Retinitis Pigmentosa associated with cystoid macular oedema treated with three loading doses of Eylea at monthly intervals followed by a treat and extend protocol between baseline and six months, and baseline and twelve months.

    To report the mean number of intravitreal injections administered in eyes of patients with Retinitis Pigmentosa associated with cystoid macular oedema treated with three loading doses of Eylea at monthly intervals followed by a treat and extend protocol between baseline and twelve months.
    E.5.2.1Timepoint(s) of evaluation of this end point
    28 days following the last visit of the last recruited patient in the study. The last visit of the last recruited patient in the study is defined as 12 months after they received their first intravitreal injection of Eylea.
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 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 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 will occur 12 months after that last patient received their first intravitreal injection of Eylea. The study will end 28 days after this visit. This is to allow time for reporting possible adverse events from the final injection.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days28
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days28
    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: 1
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 1
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 29
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 0
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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)
    Unfortunately, until the drug is licenced for RP associated CMO, the patients will not be able to receive it on the NHS. However, they will be able to receive current treatments for RP associated CMO.
    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 Decision2016-01-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-07-31
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