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    Summary
    EudraCT Number:2005-004514-32
    Sponsor's Protocol Code Number:A5751017
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-03-09
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2005-004514-32
    A.3Full title of the trial
    A 102-Week, open label, multicenter trial to investigate the efficacy of macugen for the preservation of visual function in subjects with neovascular age-related macular degeneration (AMD) and to assess the benefit of treating early choroidal neovascularization (CNV)
    A.4.1Sponsor's protocol code numberA5751017
    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 SponsorPfizer S.A. Belgium
    B.1.3.4CountryBelgium
    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 Information not present in EudraCT
    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 nameMacugen
    D.3.2Product code Pegaptanib Sodium
    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.3.8INN - Proposed INNPegaptanib sodium
    D.3.9.2Current sponsor codeCAS: 222716–86-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.47
    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) 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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 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)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8
    E.1.2Level LLT
    E.1.2Classification code 10025411
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of Macugen 0.3 mg for the preservation of vision in subjects with early CNV lesions and established CNV lesions.
    E.2.2Secondary objectives of the trial
    To assess the efficacy of Macugen 0.3 mg for the preservation of visual function and quality of life measurements in subjects with neovascular AMD.To assess the safety of Macugen 0.3 mg in subjects with early CNV lesions and established CNV lesions.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Subjects of either gender, aged ≥ 50 years.
    2. Women must be post-menopausal (at least 24 months without a menstrual period) or be surgically sterile or if of childbearing potential, use two forms of contraception (i.e., abstinence, having a vasectomized partner, ongoing use of an approved oral, injectable or implanted contraceptive, a barrier method, or an IUD).
    -If of childbearing potential, a negative urine pregnancy test must be performed within 14 days prior to the first injection
    Note: The two forms of effective contraception must be implemented throughout the duration of the study and for at least 60 days following the last dose of study medication
    3. Adequate hematological function: hemoglobin ≥10g/dL; platelet count ≥130 x 109/L; WBC ≥ 3.8 x 109/L.
    4. Adequate renal function: serum creatinine ≤2.5 mg/dl and BUN within 2 x the upper limit of normal (ULN).
    5. Adequate liver function: serum bilirubin ≤1.5 mg/dl, GGT, SGOT/ALT, SGPT/AST, and alkaline phosphatase within 2 x ULN.
    6. Provide written informed consent prior to conducting any study related procedures
    7. Able to adhere to the treatment/visit plan.

    General Ophthalmic Inclusion Criteria:
    Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
    Note: If both eyes meet eligibility criteria, the right eye is to be selected as the study eye. Only one eye will be allowed to be included in this study.
    1. Evidence of neovascular AMD in at least one eye, in subjects with bilateral neovascular AMD would be eligible for treatment.
    2.Clear ocular media and adequate pupillary dilatation to permit good quality stereoscopic fundus photography.
    3. Baseline visual acuity of ≥ 20/320 or better than 25 EDTRS letters in the study eye.

    Inclusion Criteria for Subjects with Early CNV Lesions:
    1. Visual symptoms (i.e., blurred vision, visual loss, metamorphopsia, scotoma, etc) secondary to neovascular AMD.
    2. Evidence of CNV demonstrated by high speed ICG-A or CNV defined by FA as occult with no classic to occult with classic representing < 50% of the total lesion size.
    3. Absence of subfoveal hemorrhage or any retinal or subretinal hemorrhage(s) measuring ≥1/2 disc area in aggregate size.
    4. Absence of lipid exudation, subfoveal fibrosis, subfoveal atrophy or retinal pigment epithelial detachment.
    5. Baseline visual acuity ≥ 54 letters or equivalent (20/80 Snellen visual acuity) with vision loss < 10 ETDRS letters or equivalent (< 2 Snellen visual acuity) during three months prior to enrollment.
    6. Total area of the lesion (including associated blood and CNV) must be ≤ 12 disc areas.

    Inclusion Criteria for Subjects with Established CNV Lesions:
    1.Classic CNV on FA representing > 50% of the total lesions area OR
    2. Occult with no classic to occult with a classic representing < 50% of the total CNV lesion size on FA demonstrating either of the following
    a. retinal pigment epithelial detachment
    b. subfoveal hemorrhage or any retinal or subretinal hemorrhage(s) measuring ≥1/2 disc area in aggregate size.
    c. Lipid exudation
    d. vision loss ≥10 ETDRS letters or equivalent (≥ 2 Snellen visual acuity) during three months prior to enrollment.
    3. Total lesion size (including associated blood, CNV, fibrosis and atrophy) must be ≤12 disc areas.
    E.4Principal exclusion criteria
    1. Any prior PDT with verteporfin, thermal laser photocoagulation, external beam radiation or transpupillary thermotherapy to the study eye.
    2. Previous treatment for CNV secondary to AMD.
    3. Subjects having subfoveal fibrosis, subfoveal atrophy, or subfoveal hemorrhage >50% of the total lesion area.
    4. Subjects with fibrosis or atrophy representing > 25% of the total lesion size.
    5. Significant media opacities, including cataract, which might interfere with visual acuity, assessment of toxicity, or fundus photography. Subjects should not be entered if there is likelihood that they will require cataract surgery within the following two years.
    6. Presence of other causes of choroidal neovascularization, including pathologic myopia (spherical equivalent of –8 diopters (or more negative), or axial length of ≥ 25mm), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis.
    7. Any intraocular surgery or thermal laser to the study eye within three months of enrollment.
    8. Any ocular or periocular infection within the past four weeks.
    9. Previous posterior vitrectomy or submacular surgery
    10. Previous or concomitant therapy with intravitreous corticosteroids or a therapeutic intraocular implant device.
    11. Previous or concomitant therapy with another investigational agent to treat AMD, with the exception of oral supplements of vitamins and minerals.
    12. Presence of pigment epithelial tears or rips.
    13. Previous therapeutic radiation in the region of the study eye.
    14. Any major surgical procedure(s) within one month of enrollment.
    15. Stroke (within 12 months of enrollment).
    16. Diabetic retinopathy
    17. Uncontrolled ocular hypertension or glaucoma in the study eye
    18. Any of the following underlying diseases:
    - History or evidence of severe cardiac disease, clinical or medical history of unstable angina, acute coronary syndrome, myocardial infarction or revascularization with 6 months, ventricular tachyarrythmias requiring ongoing treatment.
    19. Any treatment with an investigational agent in the past 60 days for any condition.
    20. Known serious allergies to the fluorescein dye used in angiography or to the components of Macugen® formulation.
    E.5 End points
    E.5.1Primary end point(s)
    The mean change in distance visual acuity from baseline to week 54 in subjects with early CNV lesions and established CNV lesions by assessing best corrected distance visual acuity as measured by EDTRS score.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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 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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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
    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 months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Information not present in EudraCT
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-03-09. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 370
    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)
    As expected for normal treatment of this 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 Decision2006-04-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-06-19
    P. End of Trial
    P.End of Trial StatusCompleted
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