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    Summary
    EudraCT Number:2009-014612-34
    Sponsor's Protocol Code Number:CRFB002APT02T
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-04-19
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2009-014612-34
    A.3Full title of the trial
    Prospective, multicenter, open-label study to evaluate the safety and efficacy of intravitreal ranibizumab in patients with subfoveal or juxtafoveal choroidal neovascularization (CNV) secondary to other causes than Age-related Macular Degeneration and Pathological Myopia (angioid streaks, pseudohistoplasmosis, inflammatory chorioretinal diseases and idiopathic lesions).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to evaluate the safety and efficacy of intravitreal ranibizumab in patients with choroidal neovascularization secondary to other causes than Age-related Macular Degeneration and Pathological Myopia.
    A.4.1Sponsor's protocol code numberCRFB002APT02T
    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 SponsorAIBILI - Association for Innovation and Biomedical Research on Light and Image
    B.1.3.4CountryPortugal
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAIBILI - Association for Innovation and Biomedical Research on Light and Image
    B.4.2CountryPortugal
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAIBILI - Association for Innovation and Biomedical Research on Light and Image
    B.5.2Functional name of contact pointSandrina Nunes
    B.5.3 Address:
    B.5.3.1Street AddressAzinhaga de Santa Comba, Celas
    B.5.3.2Town/ cityCoimbra
    B.5.3.3Post code3000-548
    B.5.3.4CountryPortugal
    B.5.4Telephone number+351239480137
    B.5.5Fax number+351239480117
    B.5.6E-mailsandrina@aibili.pt
    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 - 10 mg/ml solution for injection
    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.3.1Product nameLucentis - 10 mg/ml solution for injection
    D.3.2Product code S
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    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) 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 Yes
    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 typeRecombinant humanized monoclonal antibody.
    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 with subfoveal or juxtafoveal choroidal neovascularization secondary to other causes than Age-related Macular Degeneration and Pathological Myopia (angioid streaks, pseudohistoplasmosis, inflammatory chorioretinal diseases and idiopathic lesions).
    E.1.1.1Medical condition in easily understood language
    Patients with choroidal neovascularization secondary to other causes than Age-related Macular Degeneration and Pathological Myopia.
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10060837
    E.1.2Term Choroidal neovascularization
    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 the safety and the efficacy of ranibizumab 0.5 mg intravitreal injection in the treatment of choroidal neovascularization secondary to other causes than Age-related Macular Degeneration and Pathological Myopia.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy and safety of the treatment using:
    ▪Best-corrected Visual Acuity
    ▪Number of treatments per year per patient
    ▪Mean change in retinal thickness as assessed with OCT
    ▪Ocular and systemic side effects.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male or female patients 18 years old or greater.
    2.Diagnosis of active primary or recurrent choroidal neovascularization (CNV) secondary to other causes than Age-related Macular Degeneration or Pathological Myopia. Patients previously receiving CNV therapy with verteporfin photodynamic therapy and/or intravitreal steroids in the study eye will be eligible to participate in the study if continued treatment is needed for their CNV due to FA leakage and/or re-accumulation of retinal fluid (e.g. re-accumulation of sub retinal intra retinal or sub-pigment epithelium fluid at least 1 month after last treatment will be considered eligible).
    3.The total lesion area must be ≤ 12 disc areas.
    4.Best-corrected Visual Acuity > 20/400 (20 letters in the ETDRS Chart) in the study eye.
    5.Expectation by the investigator that patient will potentially benefit from ranibizumab treatment.
    6.Willing and able to give written informed consent according to legal requirements, and who have signed the consent form prior to initiation of any study procedure.
    7.Willing and able to comply with all study procedures.
    E.4Principal exclusion criteria
    1.Previous intravitreal treatment in the study eye with bevacizumab, ranibizumab or pegaptanib.
    2.Laser photocoagulation, treatment with intravitreal steroids or verteporfin photodynamic therapy (Visudyne®) in the study eye 3 months preceding Day 1.
    3.Prior treatment in the study eye with external-beam radiation therapy, vitrectomy, or transpupillary thermotherapy.
    4.History of surgical intervention in the study eye within 6 months preceding Day 1.
    5.Previous participation in any studies of investigational drugs 3 months preceding Day 1(excluding vitamins and minerals).
    6.Ocular disorders in the study eye that may confound interpretation of study results, including exudative age-related macular degeneration, pathological myopia, retinal detachment, vitreous hemorrhage or macular hole or persistent macular edema due to uveitis or other inflammatory diseases.
    7.Concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the 12-month study period.
    8.Known serious allergies to fluorescein used in angiography, or to components of Lucentis® formulation.
    9.Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive laboratory test (> 5mIU/mL).
    10.Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant UNLESS they are: women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner; women whose partners have been sterilized by vasectomy or other means using a highly effective method of birth control (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices - IUDs). Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) are not acceptable.
    Reliable contraception should be maintained throughout the study and for 30 days after study drug discontinuation.
    E.5 End points
    E.5.1Primary end point(s)
    Best-corrected visual acuity changes.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Month 3, Month 6, Month 9 and Month 12
    E.5.2Secondary end point(s)
    - Best-corrected visual acuity gain or loss ≥ 3 ETDRS lines (15 letters)
    - Retinal Thickness changes assessed with OCT
    - Number of treatments
    - Ocular and systemic side effects
    E.5.2.1Timepoint(s) of evaluation of this end point
    Month 3, Month 6, Month 9 and Month 12
    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 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 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 concerned7
    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
    The end of the trial is the date of the last visit of the last subject undergoing the trial.
    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 months0
    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.1.1Number 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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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.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)
    (Provided in the Protocol. Normal treatment of the 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 Decision2011-05-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-12
    P. End of Trial
    P.End of Trial StatusOngoing
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