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    Summary
    EudraCT Number:2017-002061-22
    Sponsor's Protocol Code Number:RC17_0061
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-06-27
    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 number2017-002061-22
    A.3Full title of the trial
    A phase III randomized, blind, double dummy, multicenter study assessing the efficacy and safety of IV thrombolysis (alteplase) in patients with acute central retinal artery occlusion
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase III randomized, blind, double dummy, multicenter study assessing the efficacy and safety of IV thrombolysis (alteplase) in patients with acute central retinal artery occlusion
    A.3.2Name or abbreviated title of the trial where available
    THEIA
    A.4.1Sponsor's protocol code numberRC17_0061
    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 Nantes
    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 supportDGOS-PHRCN
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Nantes
    B.5.2Functional name of contact pointDirection de la recherche
    B.5.3 Address:
    B.5.3.1Street Address5 allée de l'île Gloriette
    B.5.3.2Town/ cityNantes
    B.5.3.3Post code44093
    B.5.3.4CountryFrance
    B.5.4Telephone number0033253482813
    B.5.5Fax number0033253482836
    B.5.6E-mailjulie.lebaron@chu-nantes.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 Actilyse 50 mg
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim
    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.3.4Pharmaceutical form Powder and solvent for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Aspirine 300 mg
    D.2.1.1.2Name of the Marketing Authorisation holderBAYER HEALTHCARE SAS
    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.3.4Pharmaceutical form Gastro-resistant tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    acute central retinal artery occlusion
    E.1.1.1Medical condition in easily understood language
    acute central retinal artery occlusion
    E.1.1.2Therapeutic area Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10043568
    E.1.2Term Thrombolysis
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    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 if intravenous recombinant tissue-Plasminogen Activator (rt-PA, alteplase) therapy delivered within 4.5 hours of a severe visual loss onset related to an acute CRAO improve the visual acuity at one month.
    E.2.2Secondary objectives of the trial
    1) To assess the safety of IV tPA in acute CRAO.
    2) To assess the rate of patients who are not blind anymore after treatment at one month.
    3) To assess the rate of patients who have a functional recovery at one month.
    4) To assess the impact of treatment on visual field at 3 month.
    5) To assess time-course of VA.
    6) To assess the impact of time-to-treatment administration on VA evolution.
    7) To assess the impact of treatment in global disability at 3 month.
    8) To assess the impact of treatment in quality of life related to vision at 3 month.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    General criteria:
    • Aged from 18 years to 80 years.
    • CRAO diagnosis by fundoscopic examination or non-mydriatic retinophotography (NMR) performed by an ophthalmologist.
    • Blindness defined according to WHO classification as visual acuity <1/20 (20/400).
    • Treatment intervention should be initiated by a stroke team as quickly as possible and within 4.5 hours from symptom onset.
    • No clinical (e.g headache with jaw claudication or scalp tenderness, no temporal pulse) or laboratory evidence (elevated CRP) of giant cell arteritis
    • No clinical or radiological evidence of stroke within the last 3 months.
    • Patients covered by health care insurance (social security)
    • Written informed consent obtained.

    Criteria for use of study drugs (t-PA/Aspirin)
    • No contraindication to IV t-PA
    • No contraindication to aspirin
    E.4Principal exclusion criteria
    • Symptoms onset more than 4.5 h prior to infusion start or undetermined time of symptom onset.
    • Minor VA deficit or VA rapidly improving before start of infusion.
    • CRAO without foveal ischemia.
    • Other retinal vascular disease: occlusion of branch of the CRA without significant VA loss, occlusion of the retinal vein, proliferative diabetic retinopathy or any other severe retinopathy.
    • Past ophthalmological history with best-corrected visual acuity not quantifiable with a regular visual acuity chart, and requiring an ordinal scale : light perception, hand motion or counting fingers"
    • Clinical or laboratory evidence of temporal arteritis.
    • Evidence of ICH or ischemic stroke on the pre-administration CT scan or MRI.
    • Pregnant or lactating women
    • For women of childbearing potential: positive pregnancy test (serum or urine β human chorionic gonadotropin).
    • Minors
    • Adults under guardianship or trusteeship

    Exclusion criteria related to Altepase administration:
    • Significant head trauma or prior stroke in previous 3 months
    • Symptoms suggesting subarachnoid haemorrhage
    • Arterial puncture at non compressible site in previous 7 days
    • History of previous intracranial haemorrhage
    • History of retinopathy with haemorrhagic risk
    • Intracranial neoplasm, arteriovenous malformation, or aneurysm
    • Recent intracranial or intraspinal surgery
    • Elevated blood pressure (systolic >185 mm Hg or diastolic >110 mm Hg)
    • Active internal bleeding
    • Acute bleeding diathesis, including but not limited to : platelet count <100 000/mm3, heparin received within 48 hours, resulting in abnormally elevated aPTT greater than the upper limit of normal
    • Current use of anticoagulant with INR >1.7 or PT >15 seconds
    • Current use of direct thrombin inhibitors or direct factor Xa inhibitors with elevated sensitive laboratory tests (such as aPTT, INR, platelet count, and ECT; TT; or appropriate factor Xa activity assays)
    • Blood glucose concentration <50 mg/dL (2.7 mmol/L)
    • CT demonstrating recent infarction (hypodensity >1/3 middle cerebral artery territory)
    • Seizure at onset with postictal residual neurological impairments
    • Major surgery or serious trauma within previous 14 days
    • Recent gastrointestinal or urinary tract haemorrhage (within previous 21 days), or documented ulcerative gastrointestinal disease during the last three months, or documented oesophageal varices.
    • Recent acute myocardial infarction (within previous 3 months)
    • Severe liver disease, including hepatic failure, cirrhosis, portal hypertension.
    • Known current bacterial endocarditis or pericarditis.
    • Acute pancreatitis.
    • Documented ulcerative gastrointestinal disease during the last three months.
    • Documented oesophageal varices.

    Exclusion criteria related to Aspirin administration contraindication:
    • Known hypersensitivity to aspirin, or other ingredient in the product (excipient)
    • History of asthma (anaphylaxis, angioedema, rhinitis, urticaria) induced by other salicylates or non steroidal anti-inflammatory drugs.
    • Active peptic ulceration or a past history of ulceration or dyspepsia.
    • Haemophilia or other haemorrhagic disorder constitutional or acquired (including thrombocytopenia) as there is an increased risk of bleeding.
    • Severe hepatic impairment
    • Severe renal impairment
    • Severe cardiac failure (uncontrolled)
    • Methotrexate used at doses >20mg/week, oral anticoagulant in association with acetylsalicylic acid used at anti-inflammatory doses (≥ 1 g/tablet and/or ≥ 3 g/day), or at antalgic/antipyretic doses (≥ 500 mg/tablet and/or < 3 /day)
    E.5 End points
    E.5.1Primary end point(s)
    Improvement of the VA is defined by a gain of 15 letters (0.3 log-Mar visual acuity) or more on the ETDRS VA chart between baseline and 1 month
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 month
    E.5.2Secondary end point(s)
    1) Safety in term of number, type and grade of severity of adverse reactions, especially any bleeding and any stroke (ICH and ischemic stroke) will be collected at each visit.
    2) Proportion of blindness patients after treatment. Blindness is defined according to WHO revised categories of visual impairment, as VA < 1/20 (< 20/400 or > 1.3 Log.MAR) or visual field < 10.
    3) Functional recovery is defined as visual acuity ≤ 0.5 LogMAR (or ≥ 3.2/10) at one month.
    4) Visual field will specifically assess diffuse deficit indices (MD), focal deficit indices (LV) and the sensitivity of the center point.
    5) VA changes on ETDRS chart or ordinal scale at baseline, 24 hours, 7 days, 1 month and 3 months.
    6) Mean VA improvement according to the time between onset of sign and treatment administration: 0-3hours and 3-4.5h.
    7) Global disability is assessed with the modified Rankin scale (mRS)
    8) Quality of life related to vision is assessed with the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) 3 months.
    2) 1 months.
    3) 1 month.
    4) 3 months.
    5) 3 months.
    6) 3 months.
    7) 3 months
    8) 3 months
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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) Yes
    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 concerned18
    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 Yes
    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 months27
    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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2017-06-27. Yes
    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 state70
    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)
    At the end of the study patient will receive appropriate routine medical care related to its condition based on local procedure (preventive therapy, control ophthalmic (exam° consultation….).
    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 Decision2017-09-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-01-16
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