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    The EU Clinical Trials Register currently displays   39363   clinical trials with a EudraCT protocol, of which   6448   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2017-001172-36
    Sponsor's Protocol Code Number:DX211
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-09-13
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2017-001172-36
    A.3Full title of the trial
    Efficacy and safety of dexamethasone nanoparticles eye drops in diabetic macular edema.
    A dexametazon nanopartikulum szemcsepp hatásossága és biztonságossága diabéteszes maculaödéma esetén.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of dexamethasone nanoparticles eye drops in diabetic macular edema.
    A dexametazon nanopartikulum szemcsepp hatásossága és biztonságossága diabéteszes maculaödéma esetén.
    A.4.1Sponsor's protocol code numberDX211
    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 SponsorOculis ehf.
    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 supportOculis ehf.
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOculis ehf.
    B.5.2Functional name of contact pointGudrun Asgrimsdottir
    B.5.3 Address:
    B.5.3.1Street AddressGrandagardur 16
    B.5.3.2Town/ cityReykjavik
    B.5.3.3Post code101
    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 No
    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 nameDexNP
    D.3.4Pharmaceutical form Ear/eye drops, suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDexamethasone
    D.3.9.1CAS number 50-02-2
    D.3.9.2Current sponsor codeDexNP
    D.3.9.3Other descriptive nameDEXAMETHASONE PH. EUR.
    D.3.9.4EV Substance CodeSUB170672
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboEar/eye drops, suspension
    D.8.4Route of administration of the placeboOcular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diabaetic macular edema
    E.1.1.1Medical condition in easily understood language
    Diabetic macular edema
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10012662
    E.1.2Term Diabetic eye disease NOS
    E.1.2System Organ Class 100000014915
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this study is to evaluate the efficacy and safety of DexNP in the improvement of visual acuity in subjects with DME.
    E.2.2Secondary objectives of the trial
    Morphologic changes
    Quality of Life
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must:
    a) Have DME with presence of intraretinal and/or subretinal fluid in the study eye, with central macular thickness, CMT, of ≥ 310µm by SD-OCT at baseline (Visit 2) (as measured by the Investigator and confirmed by the Reading Center)
    b) Have definite retinal thickening in the study eye due to DME involving the central macula based on the Investigator’s clinical evaluation and by SD-OCT; Note: If the DME consists of circumscribed, focal leakage that the evaluating Investigator believes should be treated with laser and no other treatments, the eye is not eligible to be a study eye.
    c) Have an ETDRS BCVA letter score ≤ 73 (Snellen 20/40) and ≥ 24 (Snellen 20/320) in the study eye at baseline (Visit 2)
    d) Have a documented diagnosis of type 1 or type 2 diabetes mellitus and a glycosylated hemoglobin A1c (HbA1c) of ≤ 12.0% at Visit 1
    e) Have a negative urine pregnancy test at Visit 1, if female of childbearing potential those who have experienced menarche and who are not surgically sterilized [bilateral tubal ligation, hysterectomy or bilateral oophorectomy] or post-menopausal [12 months after last menses]) and must use adequate birth control throughout the study period. Adequate birth control is defined as hormonal – oral, implantable, injectable, or transdermal contraceptives; mechanical – spermicide in conjunction with a barrier such as condom or diaphragm; intrauterine device (IUD); or surgical sterilization of partner. For non- sexually active females, abstinence may be regarded as an adequate method of birth control;
    f) Agree to not participate in another interventional study after providing informed consent and until the study is completed
    g) Provide written informed consent prior to any study procedure being performed and be able and willing to follow all instructions and attend all study visits
    h) Be 18-85 years of age at baseline (Visit 2), of either sex and any race or ethnicity

    E.4Principal exclusion criteria
    Subjects must not:
    a) Have macular edema considered to be due to a cause other than DME; Note: an eye should not be considered eligible if: (1) the macular edema is considered to be related to ocular surgery such as cataract extraction;(2) clinical exam and/or OCT suggest that vitreoretinal interface abnormalities disease (e.g., a taut posterior hyaloid or epiretinal membrane) is the primary cause of the macular edema, or (3) the macular edema is considered to be related to another condition such as age-related macular degeneration, uveitis, retinal vein occlusion, or drug toxicity
    b) Have a decrease in BCVA due to causes other than DME (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, previous vitreoretinal surgery, central serous retinopathy, non-retinal condition, substantial cataract, macular ischemia) that is likely to be decreasing BCVA by three lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal)
    c) Have significant macular ischemia.
    d) Have any other ocular disease that may cause substantial reduction in BCVA, including, retinal detachment, epiretinal membrane, vitreous hemorrhage or fibrosis, ocular inflammation (uveitis), other retinal inflammatory or infectious diseases
    e) Have active peri-ocular or ocular infection (e.g., blepharitis, keratitis, scleritis, or conjunctivitis)
    f) Have a history of non-infectious uveitis
    g) Have high myopia (-8 diopter or more correction)
    h) Must NOT wear contact lenses during the 12 week active treatment study period
    i) Have a history of any ocular surgery within 3 months prior to Visit 1
    j) Have a history of YAG laser capsulotomy within 3 months prior to Visit 1;
    k) Have a history of panretinal scatter photocoagulation (PRP) or focal laser within 3 months prior to Visit 1 or an anticipated need for PRP during the course of the study
    l) Have a history of prior IVT, subtenon, or periocular, non-sustained release, steroid therapy within 3 months prior to Visit 1 (e.g., triamcinolone)
    m) Have a history of intravitreal sustained release dexamethasone therapy within six months prior to Visit 1
    n) Have a history of intravitreal sustained release fluocinolone within three years prior to Visit 1
    o) Have a history of prior treatment of intravitreal (IVT) aflibercept within 8 weeks and ranibizumab/bevacizumab within 6 weeks of Visit 1
    p) Have a history of prior treatment for DME with any other (than previously listed) approved treatment which is not labeled for DME within one year prior to Visit 1
    q) Have high-risk proliferative diabetic retinopathy (PDR), defined in the ETDRS study as at least one of the following:
    • New vessels within one disc diameter of the optic disc (NVD) ≥ 1/3 disc area;
    • Any NVD with vitreous or pre-retinal hemorrhage;
    • New vessels elsewhere in the retina (NVE) ≥ ½ disc area and pre-retinal or vitreous hemorrhage;
    r) Have uncontrolled ocular hypertension or glaucoma in either eye, defined as intraocular pressure (IOP) ≥ 22 mmHg on more than 1 IOP lowering medications at Visit 1
    s) Have poor media clarity, pupillary constriction (i.e., senile miosis), or lack cooperation that, in the opinion of the evaluating Investigator, would interfere with any study procedures, evaluations, or interpretation of data
    t) Have any ocular condition that, in the opinion of the Investigator, may require intervention, interfere with evaluations of efficacy or safety or interpretation of data collected in the study
    u) Have an estimated Glomerular Filtration Rate (eGFR) of < 15mL/min/1.73m2 as per CKD-EPI equation at Visit 1
    v) Have a systolic blood pressure < 90 or > 160 mmHg and / or a diastolic blood pressure > 100 mmHg at Visit 1 and 2
    w) Have a known or suspected hypersensitivity to any components of the test agent, the comparator drug, or to fluorescein
    x) Be a female subject who is pregnant or lactating or has a positive pregnancy test at Visit 1 or has been pregnant within 6 months before Visit 1 or breast-feeding within 3 months before Visit 1, or planning to become pregnant within 9 months from Visit 1
    y) Have participated in any interventional clinical study or been treated with any investigational drugs within 30 days or 5 half-lives of the investigational drug, whichever is longer, prior to the initiation of Visit 1
    z) Have any other condition, which in the opinion of the evaluating Investigator, precludes the subject’s participation in the trial
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint of the study is change in ETDRS BCVA from baseline at 12 weeks.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    E.5.2Secondary end point(s)
    Secondary endpoints of the study are number of patients with BCVA improvements of ≥10 or 15 letters versus baseline, central macular thickness on OCT, intraocular pressure, patient satisfaction
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 weeks
    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. 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 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 Yes
    E.8.2.3Other No
    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 EEA13
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    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.1.1.1In 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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 46
    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 96
    F.4.2.2In the whole clinical trial 96
    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)
    Standard of care
    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 Decision2017-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-03-28
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