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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7312   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).

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    Summary
    EudraCT Number:2009-015681-55
    Sponsor's Protocol Code Number:C-09-023
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-11-19
    Trial results View 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 ConcernedAustria - BASG
    A.2EudraCT number2009-015681-55
    A.3Full title of the trial
    A Dose-Escalation Study of AL-39324 Suspension versus Lucentis™ for the Treatment
    of Exudative Age-Related Macular Degeneration
    A.3.2Name or abbreviated title of the trial where available
    Wet AMD AL-39324 Treatment Examination (WALTZ)
    A.4.1Sponsor's protocol code numberC-09-023
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAlcon Research, Ltd.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    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 nameAL-39324 Suspension
    D.3.2Product code AL-39324
    D.3.4Pharmaceutical form Injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNLinifanib
    D.3.9.1CAS number 796967-16-3
    D.3.9.2Current sponsor codeAL-39324
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number1.00 to 4.50
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Lucentis
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameLucentis
    D.3.2Product code Lucentis
    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 IMPIntravitreal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRANIBIZUMAB
    D.3.9.1CAS number 347396-82-1
    D.3.9.2Current sponsor codeLucentis
    D.3.9.3Other descriptive nameLucentis
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    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
    exudative age-related macular degeneration
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10067791
    E.1.2Term Wet macular degeneration
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level PT
    E.1.2Classification code 10025409
    E.1.2Term Macular degeneration
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this study is to assess the safety, tolerability and the effects of treatment on ocular outcomes following a single intravitreal administration of AL-39324 suspension in subjects with exudative AMD.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient must be willing to give written informed consent, make the required study visits and follow instructions

    2. Patient must be 50 years of age or older

    3. The study eye must have:
    • primary subfoveal choroidal neovascularization (CNV) secondary to AMD, including predominantly classic, minimally classic or occult lesions
    • a lesion area < 12 disc areas (30 mm2) of any lesion type (predominantly classic, minimally classic or occult)
    • the total area of CNV (including both classic and occult components)
    must comprise ≥ 50% of the total lesion area; total lesion area is
    defined as the area with angiographic evidence of neovascularization
    associated contiguous areas of serous elevation of the RPE, elevated
    blocked fluorescence, and/or late staining
    • a new diagnosis of exudative AMD or evidence of recent disease progression within the last 3 months; if the CNV in the study eye is minimally classic or occult, evidence of recent disease progression is defined as having experienced a loss of at least 1 line of vision (5 ETDRS letters or one Snellen line), a change in lesion size of more than 2.54 mm2 (1 disc area) or the appearance of new blood in the lesion
    • retinal edema as measured by a central retinal thickness of >340 μm using a Spectralis OCT imaging system
    • a best-corrected visual acuity (BCVA) ranging between 73 letters (20/40 Snellen equivalent) and 34 letters (20/200 Snellen equivalent), inclusive
    • clear ocular media and adequate pupil dilation to permit good quality photographic imaging

    4. Patient’s fellow eye best corrected visual acuity (BCVA) must be 34 letters (Snellen equivalent 20/200) or better
    E.4Principal exclusion criteria
    1. Patient has received any previously administered therapy, approved or investigational, for exudative AMD in the study eye

    2. Any current or history of ocular disease in the study eye that, in the opinion of the Investigator, may confound assessment of the macula or affect central vision, other than non-exudative AMD (for example: vein occlusion, diabetic retinopathy, uveitis, angioid streaks, histoplasmosis, pathological myopia, retinal detachment, epiretinal membrane, macular hole)

    3. Any active intraocular inflammation in the study eye.

    4. Any evidence in the study eye of fibrosis or scarring within the lesion

    5. Any vitreous hemorrhage or a history of rhegmatogenous retinal detachment in the study eye

    6. History or evidence of the following surgeries in the study eye:
    • penetrating keratoplasty or vitrectomy
    • cataract surgery or Lasik within the last 3 months
    • OR expected to have cataract removal surgery during the study

    7. Any active ocular infections in either eye (such as: blepharitis, infectious conjunctivitis, keratitis, scleritis, endophthalmitis)

    8. A history or medical diagnosis of uncontrolled glaucoma (defined as intraocular pressure >25 mmHg despite treatment with anti-glaucoma medication) or advanced glaucoma resulting in a cup/disc ratio >0.8 in the study eye or glaucoma filtration surgery in the study eye

    9. Aphakia in the study eye or violation of the posterior capsule in the study eye, unless it occurred as a result of a YAG laser posterior capsulotomy in association with prior, posterior intraocular lens implantation

    10. Current use or likely to require treatment with a systemic medication known to be toxic to the lens; including psoralen, risedronic acid and Tamoxifen

    11. Current use or history of chronic therapy with systemic or topical ocular corticosteroids (defined as multiple doses taken daily for 3 or more consecutive days at any time within 6 months prior to enrollment)

    12. History of a medical condition (disease, metabolic dysfunction, physical examination finding or clinical laboratory finding) that, in the opinion of the Investigator, would preclude scheduled study visits, completion of the study or a safe administration of study medication (e.g., unstable or progressive cardiovascular, pulmonary, Parkinson's, liver or renal disease, cancer or dementia)

    12. Any screening laboratory result (hematology, serum chemistry or urinalysis) that in the opinion of the Investigator is not suitable for study participation; any screening liver function test value [AST (SGOT), ALT (SPGT), alkaline phosphatase, GGT, total bilirubin, direct bilirubin, indirect bilirubin, and LDH] that is more than twice the upper limit of normal

    13. History of severe or serious hypersensitivity to any components of the test article (see Section 6.1.1. Study Medication), control article or clinically relevant sensitivity to fluorescein dye, as assessed by the Investigator

    14. Female of childbearing potential (those who are not surgically sterilized or post-menopoausal) may not participate in the study if any of the following conditions exist:
    • Pregnant (positive serum pregnancy test at screening) or intend to become pregnant
    • Nursing (lactating)
    • Do not agree to use adequate birth control methods for the duration of the study (adequate birth control methods are: hormonal –oral, implantable, transdermal or injectable contraceptives; mechanical – spermicide in conjunction with a barrier such as condom or diaphragm, IUD or surgical sterilization of partner
    Note: All females of childbearing potential must consent to a serum pregnancy test upon entering and exiting the study
    Note: Instruct each female of childbearing potential to immediately inform the investigator if she becomes pregnant during the study. Should this occur, the Investigator shall immediately contact the Sponsor as detailed in Section 12.7

    15. Participation in an investigational drug or device study within 30 days of screening

    16. Medical Monitor opinion that a person is ineligible to participate in the study for a sound medical reason prior to enrollment into the study
    E.5 End points
    E.5.1Primary end point(s)
    The objective of this study is to assess the safety, tolerability and the effects of treatment on ocular outcomes following a single intravitreal administration of AL-39324 suspension in patients with exudative AMD.

    The primary safety endpoint of the study is the incidence of targeted adverse events that occur in the study eye within 7+1 days of the intravitreal injection.

    The secondary endpoint of the study is the mean reduction from baseline through Month 1 of central foveal thickness due to exudative AMD, and mean change in BCVA from baseline through the time of patients’ escape to standard of care.
    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 Yes
    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 No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    patient and evaluating investigator are blinded
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 9
    F.4.2.2In the whole clinical trial 35
    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 Decision2010-03-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-12-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-06-20
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