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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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:2010-023923-78
    Sponsor's Protocol Code Number:FH-1.3
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-01-27
    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 ConcernedAustria - BASG
    A.2EudraCT number2010-023923-78
    A.3Full title of the trial
    “ A prospective clinical trial to evaluate the V4 Drug delivery device for long term delivery of Ranibizumab for the Treatment of Choroidal Neovascularization”
    A.3.2Name or abbreviated title of the trial where available
    Drug Delivery Device for Long Term Delivery of Ranibizumab for the Treatment of Choroidal Neovascula
    A.4.1Sponsor's protocol code numberFH-1.3
    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 SponsorForsight Vision 4, 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 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 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.3.4Pharmaceutical 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.3.11 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 typeLucentis is a recombinant, humanized IgG1 kappa monoclonal antibody Fab fragment designed for intravitreal administration.
    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
    Choroidal Neovascularization (CNV) secondary to Age-related Macular Degeneration (AMD) is among the leading causes of blindness in the world. The primary treatment modality is injection of Lucentis into the vitreous. Such treatment maintains baseline vision in ~90% of patients and improves vision in ~40% of patients and has thus become the first treatment of choice for this disease.
    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
    The goal of this study is to determine whether the ForSight Vision 4 drug delivery device used for sustained release of Lucentis can provide clinical measurable benefit over an extended period of time in patients with CNV secondary to AMD and for whom standard treatment with Lucentis is indicated.
    E.2.2Secondary objectives of the trial
    Specific study objectives have been identified, as follows: Demonstrate that using the V4 sustained release device, a significant reduction of at least 30µm is observed using OCT over a period of 2 months or more.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male and female patients at least 50 years of age who meet the following entry criteria will be eligible for enrollment in this study: 1. Diagnosis of CNV secondary to AMD confirmed by fluorescein angiography, not previously treated, and 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). 2. Retinal thickness due to edema of at least 300µm in study eye 3. Not eligible for laser treatment 4. Best corrected visual acuity of 20/50 or worse in the eye to be treated 5. Best corrected visual acuity of 20/40 or better in the fellow eye 6. Good visibility of macular area on biomicroscopy 7. 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.
    E.4Principal exclusion criteria
    Patients with the following characteristics will be excluded from the study: 1. Evidence of scarring CNV (e.g. geographic atrophy) in the study eye 2. Fibrosis ≥75% of lesion area in the study eye 3. Vision better than 20/50 in the study eye 4. Any ophthalmic surgery performed on the study eye within three (3) months prior to study 5. Any prior treatment with an anti-VEGF agent (i.e. Lucentis, Avastin, Macugen, VEGF Trap-Eye) in the study eye 6. Prior vitrectomy in the study eye 7. Any previous or current retinal vascular disease in the study eye 8. Myopia > -6D 9. Clinically significant inflammation or infection within six (6) months prior to study. 10. Use of anticoagulant or antiplatelet therapy other than aspirin and non-steroidal anti-inflammatory agents (NSAID) within 14 days of enrollment 11. Presence of non-healing wound, ulcer, fracture or any medical condition associated with bleeding 12. Use of antimitotic or antimetabolite therapy within 30 days or 5 elimination half-lives of enrollment 13. History of stroke or myocardial infraction or other high risk patients for cardiovascular or cerebrovascular disease (package insert of Lucentis) 14. Glaucoma or ocular hypertension 15. Uncontrolled systemic disease (e.g., diabetes, hypertension, etc.) that in the opinion of the investigator could confound the study outcomes or prevent the patient from completing the study 16. Participation in any study involving an investigational drug within the past 30 calendar days, or ongoing participation in a study with an investigational product. 17. Intolerance or hypersensitivity to topical anesthetics, mydriatics, any of the excipients in Lucentis, fluorescein or components of the drug delivery device 18. A medical condition, serious concurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up 19. Any condition that, in the opinion of the investigator, would jeopardize the safety of the patient.
    E.5 End points
    E.5.1Primary end point(s)
    Retinal Thickness on OCT and Visual Acuity
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 Information not present in EudraCT
    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
    In case no response is seen (≥30 µm reduction in retinal thickness) during the first 4 weeks following placement of the device, the device will be re-injected with 500 µg of Lucentis. If no response is then seen (≥30 µm reduction in retinal thickness) in the following 2 weeks, the patient will be exited from the study and receive standard of care. The drug delivery device will be removed at 12 months unless removed upon earlier study exit.
    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 days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    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 device will be removed and returned to Forsight Vision 4, Inc. at visit 17 (12 Months) or upon earlier study exit. At that time the patient will be returned to normal standard of care at the descretion of the physician.
    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 Decision2011-03-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-30
    P. End of Trial
    P.End of Trial StatusOngoing
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