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    Summary
    EudraCT Number:2009-015106-19
    Sponsor's Protocol Code Number:MD7110852
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-12-09
    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 ConcernedGermany - BfArM
    A.2EudraCT number2009-015106-19
    A.3Full title of the trial
    A Phase 2b Dose-Ranging Study of Pazopanib Eye Drops versus Ranibizumab Intravitreal Injections for the Treatment of Neovascular Age-Related Macular Degeneration
    A.4.1Sponsor's protocol code numberMD7110852
    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 SponsorGlaxoSmithKline Research and Development
    B.1.3.4CountryUnited Kingdom
    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 namePazopanib Eye Drops
    D.3.2Product code GW786034
    D.3.4Pharmaceutical form Eye drops
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPAZOPANIB
    D.3.9.1CAS number 444731-52-6
    D.3.9.2Current sponsor codeGW786034
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 Europharm Limited
    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.3.4Pharmaceutical 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 INNRANIBIZUMAB
    D.3.9.1CAS number 347396-82-1
    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 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) 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 Yes
    D.3.11.13.1Other medicinal product typeRanibizumab is a humanised monoclonal antibody fragment produced in Escherichia coli cells by recombinant DNA technology
    D.IMP: 3
    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 namePazopanib Eye Drops
    D.3.2Product code GW786034
    D.3.4Pharmaceutical form Eye drops
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPAZOPANIB
    D.3.9.1CAS number 444731-52-6
    D.3.9.2Current sponsor codeGW786034
    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 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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboEye drops
    D.8.4Route of administration of the placeboOcular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Age-Related Macular Degeneration
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate if pazopanib eye drops can maintain or possibly improve vision, while reducing the continued need for intravitreal injections.
    E.2.2Secondary objectives of the trial
    1. To compare safety and tolerability between each pazopanib arm and comparator arms.
    2. To compare retinal anatomical changes between each pazopanib arm and comparator arms.
    3. To determine the steady-state plasma pazopanib concentrations after topical ocular administration.
    4. To evaluate the response by complement factor H Y402H genotypes in each pazopanib arm and comparator arms.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Eligibility criteria 5-9 apply to the study eye only.
    1. Subject understands the procedures, agrees to participate in the study (including participation in the CFH Y402H pharmacogenetics research), and has signed and dated the informed consent form prior to the initiation of any study-related activities. If the subject is unable to read or sign the consent form due to visual impairment, then alternate approaches may be followed.
    2. Subject is a male or female adult 50 years of age or older.
    3. Female subject is of non-childbearing potential defined as being physiologically incapable of becoming pregnant.
    4. Subject is able and willing to comply with the study requirements (for example, able to open the eye drop foil-wrap packaging and eye drop vials, willing to adhere to the daily dosing schedule for the treatment duration), anticipates remaining in local vicinity for duration of trial, and is able and willing to attend all scheduled visits.
    5. At the Screening Visit, subject has an active subfoveal CNV lesion secondary to AMD that is in need of re-injection.
    6. At the Screening Visit, the total lesion area is <=12 disc areas with CNV contributing >=50% of the total lesion area. Serous retinal pigment epithelial detachment (PED), fibrosis, atrophic scar and subretinal hemorrhage combined are <50% of the total lesion area. Fibrosis alone is <=25% of the total lesion area. If the subretinal hemorrhage involves the fovea, then subfoveal hemorrhage is <=1 disc area.
    7. Subject has the following anti-VEGF intravitreal injection history:
    a. At least 3 anti-VEGF IVT injections prior to the Screening Visit. At least 2 of the pre-screening injections must have occurred in the 6 months prior to the Screening Visit. This may include subjects who were first treated as recently as 3 months prior to screening.
    b. Previous response to anti-VEGF injection therapy, which is defined as a meaningful reduction (at least 50 microns) in center point thickness or equivalent field for given OCT machine.
    c. Investigator anticipates the subject has a continued need for and is expected to benefit from anti-VEGF therapy.
    8. At the Screening Visit, subject has best corrected VA in the study eye of at least 24 letters using the Early Treatment of Diabetic Retinopathy Study (ETDRS) grading charts. This calculated letter range minimum number of letters equates to approximately at least 20/320 Snellen VA equivalents.
    9. Subject has ocular media and pupillary dilation that permits adequate quality fundus imaging.
    10. Subject has liver chemistry findings prior to randomization that are within normal limits or clinically insignificant.
    11. Subject has a QTcb or QTcf (QT interval corrected for heart rate according to Bazett’s or Friederica’s formula, respectively) value <450 msec, or <480 msec for subjects with Bundle Branch Block, based on ECG testing during the Screening Period.
    E.4Principal exclusion criteria
    1. Subject has ever been treated in the study eye with IVT steroids, investigational (i.e., unapproved) drugs for CNV (exception: bevacizumab is permitted), pazopanib, investigational devices for CNV, previous subfoveal or juxtafoveal focal laser photocoagulation, photodynamic therapy with verteporfin, radiation or transpupillary thermotherapy, history of submacular surgery or other surgical intervention for AMD.
    2. Subject has a history in the study eye of vitrectomy surgery, scleral buckle, glaucoma filtering/shunt surgery, or corneal transplant. Prior cataract surgery and prior Nd:YAG (neodymium-doped yttrium aluminium garnet) laser posterior capsulotomy for treatment of posterior capsule opacification are permitted if performed more than 3 months prior to Screening Visit and a posterior chamber intraocular lens is in place.
    3. Within 6 months prior to the Screening Visit, the subject has received treatment with any systemically administered anti angiogenic agent (e.g., bevacizumab, sunitinib, cetuximab, sorafenib, pazopanib).
    4. Within 6 months prior to the Screening Visit, the subject has received treatment with medications known to be toxic to the eye (e.g., desferoximine, chloroquine/hydrochloroquine, chlorpromazine, phenothiazines, tamoxifen, nicotinic acid, and ethambutol). With the exception of low doses (a daily dose <10 mg prednisone or equivalent) of corticosteroids, the use of systemic (oral, intravenous, intrathecal) corticosteroids or any ocular steroid application to the study eye within 3 months of the Screening Visit is prohibited.
    5. Subject has center-fovea involvement of any of the following: fibrosis, atrophy, PED, or retinal pigment epithelial tear. Subject has CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia.
    6. Concurrent Ocular Conditions (specific to study eye unless stated):
    a. Subject is unwilling to refrain from wearing contact lenses starting
    b. Subject has clinical evidence of diabetic retinopathy or diabetic macular edema.
    c. Subject has any concurrent intraocular condition that could require medical or surgical intervention during the study or likely lead to clinically significant effect in VA or retinal thickness.
    d. Subject has active or recent (within 4 weeks) intraocular inflammation.
    e. Subject has current vitreous hemorrhage.
    f. Subject has a history of rhegmatogenous retinal detachment or macular hole (stage 2 or greater).
    g. Subject has an active allergic or infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.
    h. Subject has a spherical equivalent of the refractive error demonstrating more than 8 diopters of myopia. For a subject who has undergone prior refractive or cataract surgery the preoperative refractive error cannot exceed 8 diopters of myopia.
    i. Subject has uncontrolled glaucoma (intraocular pressure >25 mmHg) despite treatment with antiglaucoma medication.
    j. Subject is unable to be photographed to document CNV due to cataract obscuring the CNV, known allergy to fluorescein, or lack of venous access, or other reasons.
    k. Subject has other ocular disease or progressive retinal disease likely to affect VA during the study.
    l. Subject is aphakic.
    m. Subject is phakic or pseudophakic with evidence of instability of the intraocular lens (e.g., zonular dehiscence or weakness, displaced lens, vitreous prolaps).
    n. Subject has a history of idiopathic or autoimmune-associated uveitis.
    7. Concurrent Systemic Conditions: Subject has significant uncontrolled or unstable cardiovascular, nervous system, pulmonary, renal, endocrine, or gastrointestinal disease. In addition, a subject is excluded for the following conditions:
    a. Subject has had a myocardial infarction or cerebrovascular accident within 6 months prior to the Screening Visit.
    b. Subject has mean blood pressure ≥150/95 mmHg, with or without antihypertensive medication(s).
    c. Subject has unstable liver disease or known biliary abnormalities (with the exception of Gilbert’s syndrome, or asymptomatic gallstones), presence of hepatitis B surface antigen, or positive hepatitis C test result within 3 months of the Screening Visit.
    d. Subject is receiving current treatment for active systemic infection or has a history of recurrent significant infections.
    e. Subject has had an active bleeding disorder or a history of hemoptysis, cerebral or clinically significant gastrointestinal hemorrhage within 6 months of the Screening Visit.
    f. Subject has had major surgery within 1 month of the Screening Visit.
    g. Subject has received an allogeneic bone marrow transplant.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in BCVA as measured by the number of letters read on the ETDRS grading charts at a starting distance of 4 meters at 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 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 Yes
    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 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.8.3 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    End of study is defined as the last visit for the last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days14
    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.1.3Elderly (>=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 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 state64
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 215
    F.4.2.2In the whole clinical trial 525
    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)
    Subjects who participate in this study will have their AMD managed post-study according to the standard of care. Post-study management begins at the conclusion of the Follow-up Visit. There are no definitive plans to offer the subjects who participate in this study continued access to investigational pazopanib eye drops, although an extension study is being considered.
    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 Decision2010-01-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-10-05
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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