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    Summary
    EudraCT Number:2015-003816-19
    Sponsor's Protocol Code Number:V4061
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-06-27
    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 ConcernedLatvia - SAM
    A.2EudraCT number2015-003816-19
    A.3Full title of the trial
    A Controlled Safety and Preliminary Efficacy Study of the V406 Port Delivery System in the Treatment of Choroidal Neovascularization Due toAge-Related Macular Degeneration
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the safety and efficacy of a treatment for Patients with macular degeneration using a Device for inter vitreol administartion
    A.4.1Sponsor's protocol code numberV4061
    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 SponsorForSight VISION4, Inc
    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 supportForSight VISION4, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Research Foundation
    B.5.2Functional name of contact pointOleg Polnjak
    B.5.3 Address:
    B.5.3.1Street AddressLacpleasa St 45a
    B.5.3.2Town/ cityLielvarde
    B.5.3.3Post codeLV 5070
    B.5.3.4CountryLatvia
    B.5.4Telephone number+37122316070
    B.5.6E-mailoleg.polnjak@crfound-eeu.org
    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.3.4Pharmaceutical form Eye drops, solution in single-dose container
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOphthalmic use (Noncurrent)
    Intravitreal 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.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 - Ranibizumab
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Ophthalmic insert
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular use
    Intraocular 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 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
    Patients of either sex, 50 years of age or older, with a diagnosis of Choroidal Neovascularization CNV due to Age-Related Macular Degeneration AMD in the study eye
    E.1.1.1Medical condition in easily understood language
    A condition derived form Age related macular degeneration of the eye
    E.1.1.2Therapeutic area Body processes [G] - Ocular Physiological Phenomena [G14]
    MedDRA Classification
    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 the ocular and systemic safety of sustained intraocular pazopanib delivery from the V406 PDS Implant in patients with choroidal neovascularization(CNV) due to age-related macular degeneration (AMD)
    E.2.2Secondary objectives of the trial
    • To determine the preliminary efficacy of sustained intraocular pazopanib delivery as assessed by macular thickness reduction measured by Optical Coherence Tomography (OCT).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males and females 50 years of age or older
    2. Capable of understanding the requirements of the study, willing to follow study instructions, to provide written informed consent to participate, and who agree to comply with all study requirements, including the required study follow-up visits.
    3. Diagnosis of CNV secondary to AMD confirmed by fluorescein angiography for which anti-VEGF intraocular injection is indicated (> 25% active disease with < 75% of the lesion size representing scar, pigment epithelial detachment, blood or atrophy).
    4. Intravitreal treatment of study eye with VEGF-inhibitor(s) ranibizumab, bevacizumab, or Eyelea (aflibercept) within the past 12 months, with demonstrated response (decrease in central subfield foveal thickness (CSFT) of 50 µm or greater from prior measurement).
    5. Increased retinal thickness defined as central subfield foveal thickness (CSFT) in excess of + 2 standard deviations of normal (315 microns as measured by Spectralis OCT).
    6. CSFT must measure 50 µm greater than the lowest CSFT following the anti-VEGF injection to which responsiveness had been confirmed within the preceding 6 months.
    7. Best corrected visual acuity between 20/80 and counting fingers in the eye to be treated
    8. Best corrected visual acuity in fellow eye ≥ study eye
    9. Sufficient media clarity to allow for good visibility of macular area on biomicroscopy
    If both eyes of an individual qualify, the eye with the worse BCVA will be selected as the study eye. If both eyes have the same BCVA, the study eye will be the eye with the worse macular edema.
    E.4Principal exclusion criteria
    1. Prior vitrectomy in the study eye
    2. Any periocular/intraocular injections in the study eye in the past 2 months.
    3. Any ophthalmic surgery performed on the study eye within the past 1 month
    4. Recent or current evidence of ocular infection or inflammation in either eye.

    5. Use of anticoagulant, non-inclusive of non-steroidal anti-inflammatory agents (NSAID) or aspirin, within 14 days of enrollment
    6. Uncontrolled glaucoma defined as IOP greater than 25 mm Hg.
    7. Hypotony (defined as IOP of 5 mm Hg or less)
    8. Uncontrolled hypertension, systolic BP > 155 mm Hg.
    9. Uncontrolled systemic disease (eg, diabetes, hypertension, etc.) that in the opinion of the Investigator could confound the study outcomes or prevent the patient from completing the study
    10. Participation in any study involving an investigational drug within the past 30 calendar days, or ongoing participation in a study with an investigational product.
    11. Known intolerance or hypersensitivity to any component of the investigational drug or ranibizumab formulations to be used (eg, polyvinylpyrrolidone [PVP], cyclodextrins), components of the drug delivery device (polymethyl methacrylate [PMMA], titanium, silicone), or to topical anesthetics, mydriatics or antibiotics.
    12. Females who are pregnant or nursing and women of childbearing potential who are not using adequate contraceptive precautions (eg, intrauterine device, oral contraceptives, barrier method or other contraception deemed adequate by the Investigator)
    13. Have angioid streaks, presumed ocular hisoplasmosis syndrome, myopia (> 8 diopters) or CNV secondary to other causes than AMD
    14. Any additional ocular disease, which may have irreversibly compromised visual acuity of the study eye including amblyopia, anterior ischemic optic neuropathy, or diabetic retinopathy
    15. Inability to obtain photographs, fluorescein angiography (FA) or OCT to document CNV, eg, due to media opacity, allergy to fluorescein dye or lack of venous access
    16. Any condition that, in the opinion of the investigator, would jeopardize the safety of the subject
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Variable:
    • Absolute change from baseline in Central Subfield Foveal Thickness (CSFT) in the study eye as measured by OCT at Week 4 following dosing initiation (Week 4 in ranibizumab injection group and Week 6 in V406 PDS group)
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 and 6 weeks from study initiation
    E.5.2Secondary end point(s)
    Secondary Efficacy Variable:
    • Absolute and percent change from baseline in CSFT and mean change in best corrected visual acuity (BCVA) from baseline at Weeks 4, 12, and 24 following dosing initiation.
    E.5.2.1Timepoint(s) of evaluation of this end point
    4, 12 and 24 weeks from study initation
    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) 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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Lucentis
    E.8.2.4Number of treatment arms in the trial2
    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 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
    End of trial is wwhen 30 patients ahve completed the study : 20 in V406 PDS (pazopanid) treatment group and 10
    in the ranibizumab IVT injection group
    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 months
    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) No
    F.1.2.1Number of subjects for this age range: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state30
    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)
    Treatment will continue as normal for this patient population
    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 Decision2016-10-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-29
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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