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    The EU Clinical Trials Register currently displays   35504   clinical trials with a EudraCT protocol, of which   5838   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2017-002490-19
    Sponsor's Protocol Code Number:UKER-FECD-RIPA-01
    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:2017-06-30
    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 number2017-002490-19
    A.3Full title of the trial
    Prospective single-centre randomized observer-blind placebo-controlled parallel-group phase IIa clinical trial to investigate the safety and efficacy of ripasudil 0.4% eye drops after descemetorhexis in patients with moderate to advanced Fuchs endothelial corneal dystrophy (FECD)
    Prospektive, monozentrische, randomisierte, Untersucher-verblindete placebokontrollierte klinische Prüfung der Phase IIa in Parallelgruppen zur Untersuchung der Sicherheit und Wirksamkeit von Ripasudil 0,4% Augentropfen nach Descemetorhexis bei Patienten mit mäßiger bis fortgeschrittener Fuchs'scher Hornhautdystrophie (FECD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical Trial to investigate the safety and efficacy of ripasudil 0.4% eye drops after surgical removal of the inner layer of the cornea in patients with moderate to advanced disease of the cornea (Fuchs' cornea dystrophy)
    Klinische Studie zur Untersuchung der Sicherheit und Wirksamkeit von Ripasudil 0.4% - Augentropfen nach operativer Entfernung der Innenschicht der Hornhaut bei Patienten mit mittelgradiger bis fortgeschrittener Erkrankung der Augenhornhaut (Fuchs-Dystrophie)
    A.3.2Name or abbreviated title of the trial where available
    Ripasudil in FECD
    Ripasudil bei FECD
    A.4.1Sponsor's protocol code numberUKER-FECD-RIPA-01
    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 SponsorUniversitätsklinikum Erlangen
    B.1.3.4CountryGermany
    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 supportUniversiätsklinikum Erlangen
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinikum Erlangen
    B.5.2Functional name of contact pointAugenklinik
    B.5.3 Address:
    B.5.3.1Street AddressSchwabachanlage 6
    B.5.3.2Town/ cityErlangen
    B.5.3.3Post code91054
    B.5.3.4CountryGermany
    B.5.4Telephone number004991318534477
    B.5.6E-mailfriedrich.kruse@uk-erlangen.de
    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 Glanatec Ophthalmic Solution 0.4%
    D.2.1.1.2Name of the Marketing Authorisation holderKOWA Company Ltd., Japan
    D.2.1.2Country which granted the Marketing AuthorisationJapan
    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.3.4Pharmaceutical form Eye drops
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPConjunctival use (Noncurrent)
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboEye drops
    D.8.4Route of administration of the placeboOphthalmic use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate to advanced Fuchs endothalial corneal dystrophy (FECD)
    E.1.1.1Medical condition in easily understood language
    Moderate to advanced disease of the cornea (Fuchs' cornea dystrophy)
    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 10062973
    E.1.2Term Fuchs' endothelial dystrophy
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the safety and tolerability of ripasudil 0.4% eye drops administered 3 times daily for up to 3 months after descemetorhexis in patients with moderate to advanced FECD compared to placebo
    E.2.2Secondary objectives of the trial
    • To assess the rate of AE, AR, SAE, SAR and SUSAR within the observation period of 6 months after descemetorhexis
    • To assess the effect of ripasudil on corneal endothelial cell density (ECD) within the period of 6 months after descemetorhexis
    • To assess the effect of ripasudil on corneal thickness within the period of 6 months after descemetorhexis
    • To assess the effect of ripasudil on visual acuity (BCVA) within the period of 6 months after descemetorhexis
    • To assess the effect of ripasudil on contrast sensitivity within the period of 6 months after descemetorhexis
    • To assess the need of rescue therapy (DMEK) during the observation period
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent obtained from the subject
    2. Understanding of study procedures and willingness to abide by all procedures during the course of the study.
    3. Age range: 18-95 years
    4. Diagnosis of moderate to advanced FECD with central guttae and clinical relevant corneal endothelial cell loss of <1,000 cells/mm2 and clinical indication of surgical intervention (descemetorhexis) with or without accompanying cataract operation
    5. Reduced visual acuity, defined as BCVA <20/30
    6. Woman of childbearing potential must be using a highly effective method of birth control.
    E.4Principal exclusion criteria
    1. Clinical signs or suspicion of an acute infection
    2. Acute ophthalmic infection (bacterial, viral or fungal)
    3. Any known ophthalmic disease other than FECD and/or cataract
    4. Known contra-indications for ripasudil or comparator
    5. Use of soft lenses
    6. Known severe comorbidities which may interfere with an ophthalmic surgical procedure at the discretion of the investigator
    7. Use of any inadmissible medication, e.g. glucocorticoids (any systemic administration; if topically administered any glucocorticoid eye drops to be administered >2 times per day)
    8. Nursing mother or pregnant woman, as verified by a positive pregnancy test.
    9. Known hypersensitivity to the IMPs (ripasudil or comparator), or any of their formulation ingredients.
    10. Treatment of dry eyes, such as artificial tears or hygienic eye lid cleaning
    11. Known hypersensitivity to concomitant ophthalmic medication (e.g. antibiotic eye drops or glucocorticoid-containing eye drops)
    12. Subject who is imprisoned or is lawfully kept in an institution.
    13. Employee or direct relative of an employee of the study site or the sponsor
    14. Participation in an interventional clinical study with an IMP within the last 4 weeks
    15. Previous participation in this clinical trial
    E.5 End points
    E.5.1Primary end point(s)
    The primary safety endpoint is defined as the incidence of AR and SAR within the observation period of 3 months after descemetorhexis
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months after start of intervention
    E.5.2Secondary end point(s)
    - Resolution of corneal edema within the observation period of 6 months after descemetorhexis
    - Reestablishment of a continuous endothelial cell layer within the observation period of 6 months after descemetorhexis
    - Improvement of BCVA, defined as improvement of at least of two lines of BCVA related to the individual preoperative value within the observation period of 6 months after descemetorhexis
    - Improvement of contrast sensitivity, defined as improvement of at least two lines in Mars Charts) related to the individual preoperative value within the observation period of 6 months after descemetorhexis
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months after start of intervention
    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 Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    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 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
    LVLS
    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 months30
    E.8.9.1In the Member State concerned days
    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: 21
    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 state21
    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)
    Subjects who have prematurely terminated the study treatment will continue the individual inpatient treatment in the institution according to local hospital standard until discharge from hospital followed by outpatient treatment in the ophthalmological practice of the patient’s choice. Subjects who have regularly terminated the study treatment will continue the individual outpatient treatment in the institution or in the ophthalmological practice of the patient’s choice.
    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 Decision2017-10-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-07
    P. End of Trial
    P.End of Trial StatusOngoing
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