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    Summary
    EudraCT Number:2014-001640-38
    Sponsor's Protocol Code Number:ATTRACT
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-06-18
    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 ConcernedFrance - ANSM
    A.2EudraCT number2014-001640-38
    A.3Full title of the trial
    Efficacy of Aflibercept (Eylea®) on Type 3 choroidal neovascularization.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of Aflibercept (Eylea®) on Type 3 choroidal neovascularization.
    A.3.2Name or abbreviated title of the trial where available
    ATTRACT
    A.4.1Sponsor's protocol code numberATTRACT
    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 SponsorCHU DE POITIERS
    B.1.3.4CountryFrance
    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
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU DE POITIERS
    B.5.2Functional name of contact pointFANNY ABRIAT
    B.5.3 Address:
    B.5.3.1Street AddressDirection de la Recherche-2 rue deMiletrie
    B.5.3.2Town/ cityPoitiers
    B.5.3.4CountryFrance
    B.5.6E-mailfanny.abriat@chu-poitiers.fr
    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 Aflibercept (EYLEA ®) 40mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderBAYER PHARMA AG
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameaflibercept
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravitreal use
    D.3.11 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
    Retinal diseases (type 3 choroidal neovascularization)
    E.1.1.1Medical condition in easily understood language
    Subjects with type 3 choroidal neovascularization
    E.1.1.2Therapeutic area Body processes [G] - Ocular Physiological Phenomena [G14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10060837
    E.1.2Term Choroidal neovascularization
    E.1.2System Organ Class 100000004853
    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 the efficacy of IVT administration of VEGF Trap-Eye in subjects with type 3 choroidal neovascular for a period of up to 52 weeks.
    E.2.2Secondary objectives of the trial
    - To assess the efficacy of IVT administration of VEGF Trap-Eye in subjects with type 3 choroidal neovascular for a period of up to 24 weeks.
    - To evaluate the following anatomical changes :subretinal fluid, intraretinal edema and intraretinal cysts and mean change in CRT from baseline to Week 12, 24 and 52
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Males or females aged more than 50 years
    -Patients with type 3 choroidal neovascularization assessed on FA, ICG and OCT
    oThe type 3 CNV will be defined by following chacteristics on ICG: early hyperfluorescence spot at the end of a branching retinal vessel in the macular area frequently associated with punctiform retinal hemorrhage and hot spot on late frames sometimes located in an area of hypofluorescence due to pigment epithelium detachment.
    oThe type 3 CNV will be defined by following chacteristics on OCT: Effraction of the RPE layer toward the neurosensory retina, associated with exudation within or under the retina. This typical lesion will be observed when OCT scans located on hot spots.
    -Best Corrected Visual Acuity at inclusion between 24 and 78 letters (ETDRS letter score) in the study eye (approximately between 20/320 and 20/32 Snellen equivalent)
    -Media clarity, pupillary dilation and patient cooperation sufficient to allow fundus photographs of adequate quality
    -Ability to read, understand the study procedures
    -Given written informed consent allowing participation to this study.

    E.4Principal exclusion criteria
    -Any contraindications as reported in the labelling of Eylea®: Ocular or periocular infection, Active intraocular inflammation or Hypersensitivity in the study eye
    -Any previous history of intravitreal injections in the study eye for exudative AMD in the study eye
    -Any secondary chorioretinal anastomosis due to retinal scar or fibrosis in the study eye
    -Any history of vitrectomy in the study eye
    -Media opacities preventing accurate imaging of the retina (cataract) in the study eye
    -Any other retinal disorder possibly associated with type 3 CNV (epiretinal membrane, macular hole) in the study eye
    -Intellectual deficiency
    -Any active infectious disease
    -Patients with a significant medical condition which may interfere with the evaluation of safety or efficacy of the study compound (e.g., myocardial infarction, unstable angina pectoris within 3 months prior to study inclusion, severe renal failure or patients with renal dialysis / renal transplant).
    -Confirmed intraocular pressure ≥25 mmHg or non-stable glaucoma in the study eye
    E.5 End points
    E.5.1Primary end point(s)
    Mean change from baseline in Best Corrected Visual Acuity (BCVA) as measured by ETDRS letter score at 4 meters to 52 weeks
    E.5.1.1Timepoint(s) of evaluation of this end point
    52 weeks
    E.5.2Secondary end point(s)
    -Proportion of patients gaining 3 ETDRS lines or more at 24 weeks.
    -Proportion of patients with stable visual acuity at 24 weeks (VA changes less than 3 ETDRS lines).
    -Proportion of patients with significant visual acuity loss of 3 ETDRS lines or more at 24 weeks.
    -Mean best-corrected visual acuity (BCVA) change from baseline to week 24.
    -Anatomical outcomes: Subretinal fluid, intraretinal edema and intraretinal cysts and mean change in CRT from baseline to weeks 12, 24 and 52.
    E.5.2.1Timepoint(s) of evaluation of this end point
    weeks 12, 24 and 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 Yes
    E.6.4Safety No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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
    prospective, non-randomized, multicentric (2 centres)
    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.8.2.4Number of treatment arms in the trial1
    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 concerned2
    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 years3
    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: 4
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 22
    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 state26
    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)
    NONE
    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 Decision2014-08-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-05-21
    P. End of Trial
    P.End of Trial StatusOngoing
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