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    Summary
    EudraCT Number:2009-010973-19
    Sponsor's Protocol Code Number:14130
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-09-11
    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 ConcernedFrance - ANSM
    A.2EudraCT number2009-010973-19
    A.3Full title of the trial
    A randomized, double-masked, sham-controlled phase 3 study of the efficacy, safety, and tolerability of repeated intravitreal administration of VEGF Trap-Eye in subjects with macular edema secondary to central retinal vein occlusion (CRVO)
    A.3.2Name or abbreviated title of the trial where available
    GALILEO
    A.4.1Sponsor's protocol code number14130
    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 SponsorBayer HealthCare AG
    B.1.3.4CountryGermany
    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 nameVEGF Trap-Eye
    D.3.2Product code 80418745
    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.3.9.2Current sponsor codeBAY 86-5321
    D.3.9.3Other descriptive nameVEGF Trap-Eye
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 typerecombinantly produced fusion protein
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Maculare edema secondary to Central Retinal Vein Occlusion
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10054467
    E.1.2Term Macular edema
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10007972
    E.1.2Term Central retinal vein occlusion
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the efficacy of intravitreally (IVT) administered VEGF Trap-Eye on best-corrected visual acuity (BCVA) assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart in subjects with macular edema secondary to CRVO.
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of IVT administered VEGF Trap-Eye in subjects with macular edema secondary to CRVO.
    To assess the effects of IVT administered VEGF Trap-Eye on central retinal thickness (CRT) in subjects with macular edema secondary to CRVO.
    To assess the pharmacokinetics of free and bound VEGF Trap in a subset of patients.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Center-involved macular edema secondary to CRVO for no longer than 9 months with mean central subfield thickness ≥ 250 μm on OCT.
    2. Adults ≥ 18 years.
    3. ETDRS BCVA of 20/40 to 20/320 (73 to 24 letters) in the study eye.
    4. For men and women of childbearing potential, willingness to utilize adequate contraception and not become pregnant (or have their partner[s] become pregnant) during the full course of the study. Adequate contraceptive measures include oral contraceptives (stable use for 2 or more cycles prior to screening) and other prescription pharmaceutical contraceptives, intrauterine device (IUD), bilateral tubal ligation, vasectomy, condom, or diaphragm plus either contraceptive sponge, foam, or jelly.
    5. Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures.
    6. Willingness to provide written informed consent.
    E.4Principal exclusion criteria
    1. Only one functional eye even if that eye is otherwise eligible for the study. Furthermore, subjects with only one eligible eye should not have other ocular conditions with poorer prognosis in the fellow eye.
    2. Any prior or concomitant ocular (in the study eye) treatment or surgery for macular edema secondary to CRVO, or systemic use of anti-VEGF products
    3. Any prior or concomitant therapy with another investigational agent to treat macular edema secondary to CRVO in the study eye.
    4. Any prior treatment with anti-VEGF agents in the study eye.
    5. Previous use of intraocular corticosteroids in the study eye at any time or use of periocular corticosteroids in the study eye within 3 months prior to Day 1.
    6. Previous use of intraocular or periocular corticosteroids in the fellow eye within 3 months prior to Day 1.
    7. History of vitreoretinal surgery in the study eye within 3 months prior to Day 1 (Visit 2) or anticipated within the 12 months following Day 1.
    8. Prior episode or bilateral manifestation of RVO.
    9. History of radial optic neurotomy or sheathotomy.
    10. Previous pan-retinal laser photocoagulation or macular laser photocoagulation in the study eye.
    11. Decrease in BCVA due to causes other than CRVO.
    12. History or presence of AMD (dry or wet form) that is considered by the investigator to significantly affect central vision, DME, or diabetic retinopathy defined as more than one microaneurysm outside the area of the vein occlusion in diabetic subjects in either the study eye or the fellow eye.
    13. Iris neovascularization, vitreous hemorrhage, traction retinal detachment, or preretinal fibrosis involving the macula in either the study eye or the fellow eye.
    14. Vitreomacular traction or epiretinal membrane in either the study eye or the fellow eye evident biomicroscopically or on OCT that is considered by the investigator to significantly affect central vision.
    15. Ocular inflammation (including trace or above) or external ocular inflammation in the study eye.
    16. History of idiopathic or autoimmune uveitis in either eye.
    17. Structural damage to the center of the macula in either the study eye or the fellow eye that is likely to preclude improvement in visual acuity (VA) following the resolution of macular edema.
    18. Concurrent disease in the study eye that would compromise VA or require medical or surgical intervention during the study period.
    19. Cataract surgery in the study eye within 3 months, yttrium-aluminum-garnet laser capsulotomy within the past 2 months, or any other intraocular surgery within the 3 months prior to Day 1 (Visit 2).
    20. Aphakia or absence of the posterior capsule in the study eye.
    21. Uncontrolled glaucoma, defined as intraocular pressure (IOP) ≥ 25 mm Hg on optimal medical regimen, or previous filtration surgery in either the study eye or the fellow eye.
    22. Spherical equivalent of the refractive error in the study eye of more than -8 diopters myopia (for subjects who have had refractive or cataract surgery in the study eye, preoperative spherical equivalent refractive error of more than -8 diopters myopia).
    23. Evidence at examination of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye or current treatment for serious systemic infection.
    24. Any ocular disorders in the study eye that, in the opinion of the investigator, may confound interpretation of study results.
    25. Uncontrolled hypertension defined as a single measurement of systolic > 180 mm Hg, two consecutive measurements of systolic > 160 mm Hg, or diastolic > 100 mm Hg on optimal medical regimen.
    26. Uncontrolled diabetes mellitus.
    27. History of cerebrovascular disease or myocardial infarction within 6 months prior to Day 1 (Visit 2).
    28. Renal failure requiring dialysis or renal transplant.
    29. Participation in an investigational study within 30 days prior to initial screening visit that involved treatment with any drug (excluding vitamins and minerals) or device.
    30. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, might affect interpretation of the results of the study, or renders the subject at high risk from treatment complications.
    31. Pregnancy or lactation.
    32. History of allergy to fluorescein used in fluorescein angiography.
    33. Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality to be analyzed by the site.
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of subjects who gain at least 15 letters in BCVA on the EDTRS chart compared with baseline at the Week 24 endpoint.
    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 Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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) No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA49
    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 Yes
    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 last visit of last subject.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    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 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 163
    F.4.2.2In the whole clinical trial 245
    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)
    Not different from the expected normal treatment of that condition.
    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 Decision2009-12-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-08-26
    P. End of Trial
    P.End of Trial StatusCompleted
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