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    The EU Clinical Trials Register currently displays   44311   clinical trials with a EudraCT protocol, of which   7356   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:2011-000243-24
    Sponsor's Protocol Code Number:MD7114987
    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:2011-04-26
    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 number2011-000243-24
    A.3Full title of the trial
    An open-label, phase 2a study to evaluate pazopanib eye drops
    administered for 12 weeks to patients with neovascular agerelated
    macular degeneration
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 12-Week Study of Eye Drops to Treat Wet Age-related Macular Degeneration (AMD)
    A.4.1Sponsor's protocol code numberMD7114987
    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 SponsorGlaxoSmithKline Research & Development Ltd.
    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 supportGlaxoSmithKline Research and Development
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline
    B.5.2Functional name of contact pointClinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street Address1-3 Iron Bridge Road
    B.5.3.2Town/ cityUxbridge
    B.5.3.3Post codeUB11 1BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number44 20 8990 4466
    B.5.5Fax number44 20 8990 1234
    B.5.6E-mailGSKClinicalSupportHD@gsk.com
    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
    D.3.2Product code GW786034
    D.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation No
    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 635702-64-6
    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) 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
    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 (AMD)
    E.1.1.1Medical condition in easily understood language
    Neovascular age-related macular degeneration (also called wet AMD)
    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 14.0
    E.1.2Level PT
    E.1.2Classification code 10025409
    E.1.2Term 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
    Primary Objectives:
    • To assess the effect of pazopanib eye drops on central retinal thickness
    • To evaluate the effect of pazopanib eye drops on visual acuity
    E.2.2Secondary objectives of the trial
    Secondary Objectives:
    • To assess the effect of pazopanib eye drops on central retinal lesion thickness and retinal morphology
    • To evaluate the safety and tolerability of pazopanib eye drops
    • To determine steady-state plasma concentrations with topical ocular administration
    Exploratory Objectives:
    • To explore the relationship between plasma concentrations and the effect of pazopanib eyes drops on the reduction of retinal edema and improvements in visual acuity
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects eligible for enrolment in the study must meet all of the following criteria:
    1. Consent: Subject understands the procedures, agrees to participate in the study (including participation in the CFH Y402H pharmacogenetic 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 the consent form due to visual impairment then the consent must be read to the subject verbatim by the person administering the consent, a family member, or legally acceptable representative. (Note: Consent by legally acceptable representative is allowed where this is in accordance with local laws, regulations, and ethics committee policy.)
    2. Age-related macular degeneration: For each subject enrolled in the study, only one eye (study eye) will be treated, and eligibility criteria apply to the study eye. All of the following characteristics are required and must be confirmed by the central reading center:
    • CNV caused by AMD that extends under the geometric center of the foveal avascular zone
    • Center subfield thickness (inclusive of subretinal fluid) > 320 microns on OCT [SPECTRALIS (Heidelberg)]
    • Total lesion area 12 disc areas on fluorescein angiography, where the lesion complex includes CNV, blood, blocked fluorescence not from blood, and serous detachment of the retinal pigment epithelium
    • CNV comprises  50% of lesion area
    • classic CNV comprises < 50% of the lesion area
    • fibrosis comprises ≤ 25% of lesion area
    • if no evidence of classic CNV, then presumed to have recent disease progression based on deterioration ( 5 letter decrease in vision or evidence of growth of a CNV lesion on fluorescein angiography ) within the last 3 months or evidence of hemorrhage from CNV
    3. Visual acuity: Best-corrected visual acuity score by electronic ETDRS in the study eye of between 25 and 73 letters (approximately equivalent to Snellen VA of 20/320 to 20/32) at screening
    4. Gender and age: Subject is a male or female adult 50 years of age or older.
    5. Non-childbearing potential: Female subject is of non-childbearing potential defined as being physiologically incapable of becoming pregnant. This includes any female who is post-menopausal (12 months of spontaneous amenorrhea) or who is surgically post-menopausal (via documented hysterectomy or bilateral tubal ligation). In questionable cases of postmenopausal status, a blood sample with simultaneous follicle stimulating hormone (FSH) >40 MIU/mL and estradiol <40 pg/mL (<140 pmol/L) [or equivalent values based on local laboratory criteria] is confirmatory. Refer to the SPM for more information.
    6. Study Compliance: Subject is able and willing to comply with the study requirements and is able and willing to attend all scheduled visits.
    7. Liver function tests: Subject has liver chemistry values that are within normal limits or clinically insignificant as evidenced by serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2xULN; alkaline phosphatase and bilirubin <1.5xULN (isolated bilirubin >1.5xULN is acceptable, if bilirubin is fractionated and direct bilirubin is < 35%).
    8. QT interval: Subject has a QTcF value < 450 msec, or < 480 msec for subjects with Bundle Branch Block. [Note: subjects with paced rhythms may be considered pending discussion with the medical monitor.]
    Specific information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the GSK investigational product or other study treatment that may impact subject eligibility is provided in the Investigator Brochure for Ophthalmic Indications [UM2007/0007/04, 2010].
    Deviations from inclusion criteria are not allowed because they can potentially jeopardize the scientific integrity of the study, regulatory acceptability or subject safety. Therefore, adherence to the criteria as specified in the protocol is essential.
    E.4Principal exclusion criteria
    Subjects meeting any of the following criteria must not be enrolled in the study:
    Study Eye:
    1. Additional eye disease in the study eye that could compromise best-corrected visual acuity (e.g. glaucoma with documented visual field loss, clinically significant diabetic retinopathy, ischemic optic neuropathy, infection or retinitis pigmentosa)
    2. CNV in the study eye due to other causes unrelated to age-related macular degeneration
    3. Presence of retinal angiomatous proliferation (RAP) in the study eye, as determined by the investigator (confirmation by indocyanine green angiography is not required)
    4. Geographic atrophy involving the center of the fovea in the study eye
    5. Anterior segment and vitreous abnormalities in the study eye that would preclude adequate observation of the fundus for photographs, fluorescein angiography and spectral-domain OCT
    6. Vitreous, subretinal or retinal hemorrhage in the study eye that is unrelated to AMD
    7. Presence of an RPE tear in the study eye
    8. Aphakia or total absence of the posterior capsule (Yttrium aluminum garnet (YAG) capsulotomy permitted) in the study eye
    9. History of vitrectomy in the study eye
    10. Intraocular surgery in the study eye within 3 months prior to treatment
    11. Any previous treatment in the study eye for neovascular AMD, approved or investigational
    Fellow Eye:
    12. Current intravitreal anti-VEGF therapy in the fellow eye
    13. Best-corrected visual acuity score by electronic ETDRS < 56 letters in the fellow eye at screening
    Concurrent Conditions or Concomitant Medications:
    14. Subject has uncontrolled glaucoma (intraocular pressure > 25 mmHg) despite treatment with anti-glaucoma medication.
    15. A known, positive test for Hepatitis B surface antigen or Hepatitis C antibody within 3 months of screening
    16. Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
    17. Active bleeding disorder or a history of hemoptysis, cerebral or clinically significant gastrointestinal hemorrhage within 6 months of screening
    18. Significant uncontrolled or unstable cardiovascular, nervous system, pulmonary, renal, endocrine, or gastrointestinal disease for example:
    • Uncontrolled diabetes mellitus, with hemoglobin A1c (HbA1c) > 10%
    • Myocardial infarction or stroke within 6 months of screening
    • Major surgery within 3 months of screening
    • Clinically relevant thyroid disease
    19. Uncontrolled hypertension:
    Systolic blood pressure > 160 mmHg
    Diastolic blood pressure > 100 mmHg
    Note: Initiation or adjustment of antihypertensive medications is permitted prior to study entry provided the referenced criteria are met (See Section 4.4.3).
    20. Subject has a history within the past 2 years of alcohol or substance abuse, or psychiatric disorder likely to confound the efficacy or safety assessments.
    21. Known HIV infection
    22. Within 6 months prior to the Screening Visit, use of any systemically administered anti angiogenic agent (e.g., bevacizumab, sunitinib, cetuximab, sorafenib, pazopanib), approved or investigational
    23. Within 6 months prior to the Screening Visit, use of medications known to be toxic to the retina, lens or optic nerve (e.g. desferoximine, chloroquine/hydrochloroquine, chlorpromazine, phenothiazines, tamoxifen, and ethambutol)
    24. Use of systemic steroids (>10 mg prednisone or equivalent/day) within 14 days of the start of treatment
    25. Use of prohibited medications within the restricted timeframe relative to the start of study medication (See Section 5.5.2)
    26. Use of an investigational drug within 30 days of screening
    27. History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation
    28. A condition or situation, which, in the opinion of the investigator, may result in significant risk to the patient, confound the study results or interfere significantly with participation.
    E.5 End points
    E.5.1Primary end point(s)
    • Change from baseline in central retinal thickness over time, as measured by OCT, and change from baseline in BCVA over time, as measured by the number of letters determined by EVA, with the changes after 28 days of treatment (Week 4 [Day 29] Visit) being the primary focus
    E.5.1.1Timepoint(s) of evaluation of this end point
    Screening (days -8- to -2 before baseline) to Day 29.
    E.5.2Secondary end point(s)
    OCT endpoints:
    • Change from baseline in central retinal lesion thickness over time
    • Change in intraretinal (IR) or subretinal (SR) fluid, intraretinal cysts, or serous retinal pigment epithelial detachment (PED) over time
    Visual acuity endpoints:
    • Visual acuity response over time (proportion of subjects with BCVA of various 5-letter thresholds gained or lost from baseline; proportion of subjects whose BCVA did not decline from baseline)
    Fluorescein angiographic and fundus photographic endpoints:
    • Change from baseline in the area of CNV
    • Change from baseline in the area of the CNV lesion complex (i.e., CNV, blood, PED, and fibrosis)
    Rescue endpoints:
    • Proportion of patients who receive rescue treatment
    • Time to rescue injection
    Safety endpoints:
    • Non-serious adverse events (AEs) and serious adverse events (SAEs) (both ocular and non-ocular AEs)
    • Ocular assessments on general ophthalmic examination
    • Vital signs
    • Laboratory analytes including hematology and clinical chemistries
    • Urinalysis
    Pharmacokinetic endpoint:
    • Plasma pazopanib concentrations
    Exploratory endpoints:
    • Pharmacokinetic endpoint: Response as related to plasma pazopanib concentration
    • Pharmacogenetic endpoint: Response as related to the status of genetic polymorphisms including the CFH Y402H polymorphism
    E.5.2.1Timepoint(s) of evaluation of this end point
    Screening (days -8- to -2 before baseline) to Day 29.
    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 Yes
    E.6.7Pharmacodynamic Yes
    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 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 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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    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
    Last Subject Last Visit
    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 months2
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months2
    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.1.1Number 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: 30
    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 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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 15
    F.4.2.2In the whole clinical trial 30
    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)
    The investigator is responsible for ensuring that consideration has been given to the poststudy care of the patient's medical condition. Subjects who participate in this study should be managed post-study according to the standard of care for AMD.
    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 Decision2011-05-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-04-16
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