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    Summary
    EudraCT Number:2016-002531-15
    Sponsor's Protocol Code Number:09/0959
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-09-12
    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 ConcernedUK - MHRA
    A.2EudraCT number2016-002531-15
    A.3Full title of the trial
    A phase II, open label, non-randomised, single centre, clinical trial of ANX776 in Healthy Volunteers and patients with Glaucoma, Age-Related Macular Degeneration, and Optic Neuritis

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase II clinical trial to asses efficacy and safety of DARC methodology (Detection of Apoptosing Retinal Cells) in visualising the death of retinal cells in healthy volunteers and patients with Glaucoma, Age-Related Macular Degeneration, and Optic Neuritis.
    A.3.2Name or abbreviated title of the trial where available
    A phase II clinical trial of DARC
    A.4.1Sponsor's protocol code number09/0959
    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 SponsorUCL Comprehensive Clinical Trials Unit
    B.1.3.4CountryUnited Kingdom
    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 supportThe Wellcome Trust
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameANX776
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot assigned
    D.3.9.1CAS number Not assigned
    D.3.9.2Current sponsor codeANX776
    D.3.9.3Other descriptive namerhAnnexin V-128 Dy-776-maleimide conjugate
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.16 to 0.24
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Glaucoma, Age-related Macular Degeneration, and Optic Neuritis.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10047560
    E.1.2Term Visual field perimetric tests
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level HLGT
    E.1.2Classification code 10018307
    E.1.2Term Glaucoma and ocular hypertension
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10021948
    E.1.2Term Infiltration intravenous injection
    E.1.2System Organ Class 100000004867
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10057208
    E.1.2Term Optical coherence tomography
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10071129
    E.1.2Term Neovascular age-related macular degeneration
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10064930
    E.1.2Term Age-related macular degeneration
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10047566
    E.1.2Term Visual field tests
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10009034
    E.1.2Term Chronic open angle glaucoma
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10030942
    E.1.2Term Optic neuritis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10006027
    E.1.2Term Borderline glaucoma
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10030043
    E.1.2Term Ocular hypertension
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10006028
    E.1.2Term Borderline glaucoma (glaucoma suspect)
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10004571
    E.1.2Term Bilateral optic neuritis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10012121
    E.1.2Term Defect visual field (NOS)
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10020422
    E.1.2Term HRT
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10018304
    E.1.2Term Glaucoma
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10048541
    E.1.2Term Intravenous catheter management
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary outcome is the efficacy of the intervention ascertained by the DARC Count, which is the number of apoptosing retinal cells visualised 4 hours after the ANX776 injection in patients with Glaucoma, Age-related Macular Degeneration, Optic Neuritis and in Healthy volunteers.

    E.2.2Secondary objectives of the trial
    The secondary objective is to evaluate the response in terms of safety and tolerability of ANX776 in patients with Glaucoma, Age-related Macular Degeneration, Optic Neuritis, and in Healthy volunteers. Safety is defined as absence of an adverse event of grade 3 or above in the study groups. Safety will be measured by adverse events following the Common Terminology Criteria for Adverse Events (CTCAE) scale.

    In addition, in a subset of patients, an exploratory secondary objective is to assess if the ANX776 signal is detected in the brain using functional near-infrared spectroscopy (fNIRS).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    General Inclusion Criteria are:
    1. Age ≥ 18 years
    2. Clear optical media in the studied eye.
    3. Refractive error not higher than spherical equivalent of 10 D and best corrected visual acuity equal to 6/24 or better at qualification.
    4. Women of childbearing potential identified as not pregnant and have consented to complete a pregnancy test.
    5. Subjects who have capacity to consent, and are willing to personally sign the informed consent document indicating that they have been informed of all pertinent aspects of the study.

    Group Specific Inclusion criteria are:
    Glaucoma:
    1. Glaucoma group subjects will show progression in one or more of the parameters measured and will have at least one eye with a diagnosis of glaucoma (abnormal optic disc and/or visual field defect or both); be diagnosed as a glaucoma suspect or ocular hypertensive (elevated 10P).
    2. Subjects proven to be able to perform reliable visual field testing using the HFA 640, central 24-2 program, to yield full thresholds, and have had good fundoscopy with assessment of their optic disc.


    Age-related Macular Degeneration:
    1. Patients with AMD as defined by:
    2. Early AMD mainly characterised by drusen, retinal pigment epithelium (RPE) pigment changes.
    3. Late AMD mainly characterised as: geographic atrophy of the RPE (dry AMD).
    4. Neovascular AMD (wet AMD).

    Optic Neuritis:
    1. Clinical diagnosis of optic neuritis affecting one eye within two years.
    2. Visual acuity in affected eye ≤ 6/12 at worst point.
    3. Corrected vision in unaffected eye ≥ 6/6.
    4. No history of optic neuritis or other ocular disease in either eye prior to the episode of optic neuritis.
    5. Subjects proven to be able to perform reliable visual field testing using the HFA 640, central 24-2 program, to yield full thresholds, and have had good fundoscopy with assessment of their optic disc.

    Healthy Volunteers:
    1. Confirmation of medical history as confirmed by General Practitioner.
    2. No evidence of any eye disease

    Exploratory Optional fNIRS Inclusion Criteria:
    1. Participants who are bald, or with short (less than 3cm), fair (unpigmented) hair
    E.4Principal exclusion criteria
    General Exclusion Criteria are:
    1. Presence of severe, unstable or uncontrolled systemic disease.
    2. Known intolerance to IMP.
    3. Body weight <40kg or >150kg.
    4. Inability to comply with the study or follow-up procedures.
    5. Any subjects with a known history of clotting diseases (including DVTs), and subjects taking anticoagulants.
    6. Ocular surgery within the past 3 months or planned surgery in the study eye, during the course of the trial.
    7. Pregnant, lactating, or premenopausal.
    8. Currently being treated for cancer or any other disease likely to adversely affect participation in this study.
    9. AIDS / HIV.
    10. History of alcoholism or drug addiction.
    11. History or active uveitis
    12. History of systemic vasculitis, collagenosis or ongoing treatment of cancer.
    13. Evidence of previous retinal vascular disease.
    14. Individuals with terminal illness, or mental illness affecting their compliance with the study.
    15. Central corneal thickness <450 pm or >650pm.
    16. Currently, or within the last 3 months, enrolled in a clinical trial of an Investigational Medicinal Product.
    17. History of retinal laser photocoagulation.
    18. Media opacities or retinal pathology or amblyopia significantly limiting visual acuity, visual field test or retinal imaging.
    19. Any other disease, condition or laboratory abnormality that in the opinion of the CI may increase the risk for the participation or may interfere with the interpretation of study results and in the judgement of the Investigator would make the subject inappropriate for entry into the study.

    Group Specific Exclusion criteria are:
    Glaucoma:
    1. Uncontrolled I0P >24mmHg.
    2. Angle closure/narrow glaucoma. Mean deviation at HVF >12dB.

    Age-related Macular Degeneration:
    1. Presence of ocular conditions with increased risk of choroidal neovascularisation (CNVM).
    2. Current or past use for more than 30 days of chloroquine, hydroxychloroquine, chlorpromazine, thioridazine, quinine sulfate, clofazimine, cisplatin, carmustine, (BCNU), deferoxamine, amiodarone, isoretinoin, or gold.

    Optic Neuritis:
    1. Corticosteroid use in the past 2 months.

    Healthy Volunteers:
    1. Evidence of any historical retinal eye disease.

    Exploratory Optional fNIRS Exclusion Criteria:
    1. There are no specific exclusion criteria for the exploratory optional fNIRS.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is the DARC Count in each eye 4 hours post injection. A log(x+1) transformation will be used for the statistical analysis. Geometric means and 95% confidence intervals will be used to summarise the log(x+1) DARC counts, back transformed to the original measurement scale. A regression model will be fitted to estimate the difference between each affected group and the healthy control group. The regression model will include patient as a random effect.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During injection
    15 min post injection
    2 hours post injection
    4 hours post injection

    Retinal imaging will be utilised to visualise apoptosing retinal ganglion cells at above time intervals; corresponding DARC counts inclusive of their means and standard deviations will be reported.
    E.5.2Secondary end point(s)
    Secondary outcome is the number and severity of adverse events. The overall number of adverse events will be reported, stratified by patient group, and categorised according to their nature and severity.

    For the Near-infrared spectroscopy, the outcome measure will be the detection of the NIR fluorescent signal in the brain.
    E.5.2.1Timepoint(s) of evaluation of this end point
    During injection
    15 min post injection
    2 hours post injection
    4 hours post injection

    30 days post injection - safety telephone call (adverse events only).

    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 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 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
    Healthy Volunteers
    E.8.2.4Number of treatment arms in the trial1
    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
    The end of the trial will be defined as resolution of all data queries following the last visit by the last participant.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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.3.3.6.1Details of subjects incapable of giving consent
    Some people with Downs Syndrome may not be capable of giving consent personally.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    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)
    Study Drug is not a therapeutic agent hence it will not be available outside of the trial.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-10-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-06-07
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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