Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7292   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2013-004203-39
    Sponsor's Protocol Code Number:FNKV-OFT-2013-1
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-02-06
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2013-004203-39
    A.3Full title of the trial
    A randomized, 12 months, active controlled study of the efficacy of repeated doses of intravitreal aflibercept in subjects with prolipherative diabetic retinopathy
    Randomizovaná, 12 měsíční, aktivně kontrolovaná klinická studie hodnotící účinnoat afliberceptu u pacientů s proliferativní diabetickou retinopatií.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of efect of intravitreal aflibercept in subjects with prolipherative diabetic retinopathy
    A.4.1Sponsor's protocol code numberFNKV-OFT-2013-1
    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 SponsorFakultní nemocnice Královské Vinohrady
    B.1.3.4CountryCzech Republic
    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 supportFakultní nemocnice Královské Vinohrady
    B.4.2CountryCzech Republic
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFakultní nemocnice Královské Vinohrady
    B.5.2Functional name of contact pointDepartment of clinical trials
    B.5.3 Address:
    B.5.3.1Street AddressŠrobárova 50
    B.5.3.2Town/ cityPraha 10
    B.5.3.3Post code100 34
    B.5.3.4CountryCzech Republic
    B.5.6E-mailklinickehodnoceni@fnkv.cz
    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
    D.2.1.2Country which granted the Marketing AuthorisationCzech Republic
    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 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.3.9.3Other descriptive nameAFLIBERCEPT
    D.3.9.4EV Substance CodeSUB26987
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    prolipherative diabetic retinopathy
    E.1.1.1Medical condition in easily understood language
    advanced retinal changes by patients wits diabetes
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess efficacy of aflibercept for intravitreal injection in comparison to laser treatment in subjects with prolipherative diabetic retinopathy (PDR)
    E.2.2Secondary objectives of the trial
    a) To evaluate changes of electroretinography (ERG) in subjects treated with aflibercept for intravitreal injection in comparison to laser treatment in subjects with prolipherative diabetic retinopathy (PDR)
    b) To evaluate the changes of contrast sensitivity (CS) in subjects treated with aflibercept for intravitreal injection in comparison to laser treatment in subjects with prolipherative diabetic retinopathy (PDR)
    c) To evaluate patient reported outcomes by NEI VFQ-25 changes from baseline to week 52 in subjects treated with aflibercept for intravitreal injection in comparison to laser treatment in subjects with prolipherative diabetic retinopathy (PDR)
    d) To evaluate other efficacy and safety endpoints for aflibercept for intravitreal injection in comparison to laser treatment in subjects with prolipherative diabetic retinopathy (PDR)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adults ≥ 18 years with type 1 or 2 diabetes mellitus.
    2. Subjects with PDR secondary to diabetes mellitus ( confirmed on fluorescein angiography FA)
    3. BCVA ETDRS letter score of 20/20 to 20/320 in the study eye
    4. Willing and able to comply with clinic visits and study-related procedures.
    5. Provide a signed informed consent form (ICF)
    E.4Principal exclusion criteria
    A subject who meets any of the following criteria will be excluded from the study.
    1. Decrease in vision determined to be primarily the result of DME in the study eye
    2. Laser quadrant or panretinal photocoagulation in the study eye
    3. Previous treatment with anti-antiangiogenic drugs in study eye (pegaptanib sodium, bevacizumab, ranibizumab etc.) within 90 days of Baseline visit
    4. Proliferative diabetic retinopathy in the study eye, with the inactive, regressed vessels
    5. Any intraocular surgery within 28 days of Baseline visit in the study eye
    6. Presence of tractional or rhegmatogenous retinal detachment in the study eye
    7. Any active ocular or/and periocular inflammation or infection in the study eye at Screening or Baseline visits
    8. Intraocular pressure (IOP) ≥ 30 mmHg in the study eye at Screening or Baseline visits
    9. Concurrent disease in the study eye, other than PDR, that could require medical or surgical intervention during the study period, or could confound interpretation of the results (including retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause)
    10. Ocular media of insufficient quality to obtain fundus images and ERG (e.g., cataract, corneal opacity, severe vitreous haemorrhage)
    11. Uncontrolled blood pressure defined as systolic value of >160 mmHg or diastolic value >100 mmHg eye at Screening or Baseline visits
    12. Stroke or and/or myocardial infarction less than 3 months prior to Baseline visit
    13. Pregnant or breast-feeding women.
    14. Hypersensitivity to aflibercept or to fluorescein
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy of therapy will be assessed by the change of ETDRS Diabetic Retinopathy Severity Score for proliferative diabetic retinopathy.
    Disease Severity Level Derivation from ETDRS Levels

    Subjects in each arm will be divided in three groups according to their ETDRS Score Level at Week 52 compared to Baseline ETDRS Score Level:
    Group 1: worsening of ETDRS Score Level
    Group 2: maintaining the same ETDRS Score Level
    Group 3: improvement of ETDRS Score Level
    Number and percentage of subjects in each group in both arms will be determined.
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 52
    E.5.2Secondary end point(s)
    a) Changes in ERG parameters (ROD b-wave amplitude, dark-adapted Combined Response (CR) b-wave amplitude, CR a-wave, oscillatory potentials, cone single flash, and 30 Hz flicker responses) from Baseline to Week 52
    b) Changes of Contrast Sensitivity Score from Baseline to Week 52 using Pelli –Robson charts.
    c) Changes in Patient Reported Outcomes using NEI VFQ-25 subscale from Baseline to Week 52. Standard National Eye Institute Visual Function Questionnaire-25 in Czech language.
    d) Change of intraocular pressure from Baseline to Week 52.
    e) Presence of iris neovascularisation at Week 52 compared to Baseline.
    f) Number of patients who needed rescue therapy due to progression of PDR regardless given treatment during the study.
    g) Proportion of subjects with stabilisation of PDR at Week 52 compared to Baseline as measured by ETDRS Severity Score based on the level of diabetes control
    h) Change of retinal and optic nerve disc neovascularisations size from Baseline to Week 52.
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 52
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    laserové fotokogulace
    laserphotocoagulation
    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
    Study subject has the right to withdraw from the study at any time for any reason without prejudice to his/her future medical care by the physician or institution.
    The sponsor and/or investigator maintain the right to withdraw a subject from the study in the event of adverse events, treatment failure, protocol violation, or other reasons.
    A subject must be withdrawn from the study if his/her further participation in the study is no further in the best interest of the subject.
    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 months
    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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state50
    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)
    NO
    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 Decision2014-04-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-06
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Mon May 06 19:05:54 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA