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    Summary
    EudraCT Number:2005-001460-32
    Sponsor's Protocol Code Number:EOP 1013
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-03-08
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2005-001460-32
    A.3Full title of the trial
    A Phase 2/3 Randomized, Controlled, Double-Masked, Multi-Center, Comparative Dose-Finding Trial, in Parallel Groups, to Compare the Safety and Efficacy of Intravitreous Injections of 0.3, 0.03 or 0.003 mg Pegaptanib Sodium (MacugenÒ), Given as Often as Every 6 Weeks for 3 years, to Sham Injections, in Subjects with Diabetic Macular Edema (DME) Involving the Center of the Macula.
    A.4.1Sponsor's protocol code numberEOP 1013
    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 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 Macugen
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer 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 nameMacugen
    D.3.2Product code EYE001
    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 codeEYE001
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number 0.3
    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 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 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
    Diabetic Macular Edema (DME)
    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 objectives of this trial will be to confirm the safety and compare the efficacy of pegaptanib sodium when given as intravitreous injections of 0.3 mg/eye, 0.03 mg/eye or 0.003 mg/eye versus sham injections in a 2:2:1:2 ratio, respectively, as often as every 6 weeks for 3 years, in subjects with diabetic macular edema involving the center of the macula associated with vision loss not due to ischemia.

    E.2.2Secondary objectives of the trial
    Secondary (at 1, 2 and 3 years unless specified):·

    The proportion of subjects with a ≥15 letter improvement at 1 year and 2 years.
    The proportion of eyes experiencing a change in the degree of retinopathy by 2 or more steps.
    Changes in mean visual acuity over time.
    The proportion of subjects with a ≥10 letter improvement.
    The proportion of subjects requiring focal or grid laser

    Other: Additional efficacy, safety and health related outcomes endpoints will be included.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    OPHTHALMIC CRITERIA

    1. Subjects must have macular edema that involves the center of the macula with corresponding leakage on fluorescein angiogram. Leakage will be confirmed retrospectively by the IRC.
    2. Foveal thickness of at least 300 microns (OCT center point thickness), with a standard deviation of the center point of <10%, an OCT signal strength of ≥5, and properly drawn ILM and RPE borders. As well, the initial OCT must be confirmed by repeat measurement on the same day, with the center point thicknesses being within 10% of each other. In cases that the OCT image software fails to properly draw ILM and RPE borders, if the IRC obtains a manual estimate of OCT center point thickness of at least 300 microns, then the patient will be considered eligible.
    3. Best corrected distance visual acuity in the study eye must be a letter score between 65 and 35 inclusive (20/50 to 20/200 Snellen equivalents).
    4.Clear ocular media and adequate pupillary dilatation to permit good quality stereoscopic fundus photography.
    5.Intraocular pressure of 21 mmHg, or less.
    6.The treating ophthalmologist should be comfortable that focal laser (direct and grid as needed) can be deferred for at least 18 weeks in the study eye, even though focal or grid laser is indicated.

    GENERAL CRITERIA

    1. Type I, or Type II diabetic subjects as defined by the WHO criteria, of either gender, and aged ≥18 years
    2. Performance Status ≤2 according to the Eastern Cooperative Oncology Group (ECOG) / World Health Organization (WHO) scale.
    3. Normal electrocardiogram (ECG), or clinically non-significant changes as determined by an internist.
    4. Women must be using effective contraception, be post-menopausal for at least 12 months prior to trial entry, or surgically sterile. All women of childbearing potential must have a negative serum pregnancy test at baseline and negative urine pregnancy tests immediately prior to each injection and use two effective forms of contraception during the trial and for at least 60 days following the last dose of pegaptanib sodium.
    5. Adequate hematological function: hemoglobin ≥10 g/dL; platelet count ≥130 x 109/l; WBC ≥3.8 x 109/l.
    6. Adequate liver function: serum bilirubin ≤1.5 mg/dL; SGOT/ALT, SGPT/AST, GGT and alkaline phosphatase within 2 x ULN.
    7. Adequate renal function: serum creatinine ≤ 2.5 mg/dL and BUN within 2.5 x ULN.
    8. Ability to provide written informed consent.
    9. Ability to return for all trial visits.
    E.4Principal exclusion criteria
    EXCLUSION CRITERIA

    Subjects will not be eligible for the trial if any of the following criteria are present systemically, or in the study eye:

    1. Eyes with prior scatter (panretinal) photocoagulation or eyes in which scatter (panretinal) photocoagulation is needed now or is likely to be needed within the next 9 months (e.g. eyes with DRS high risk PDR not already adequately treated with photocoagulation).
    2. Presence of any abnormality that is likely to confound assessment of visual acuity improvement in eyes in which macular edema resolves, or improves, such as non-perfusion for >1 disc area involving the foveal avascular zone (FAZ - involving 2 or more quadrants centered around the foveal avascular zone), epiretinal membrane associated with signs of contraction and/or significant opacification (i.e. striae within 1 disc diameter of the foveal center), or presence of chorioretinal atrophy involving the center of the macula.
    3. Vitreomacular traction determined clinically and/or by OCT, which, in the investigator’s opinion, contributes to the macular edema (or causes associated foveal detachment), and would preclude improvement with pegaptanib sodium or sham treatment.
    4. Any other cause of macular edema such as vitreous extension, or entrapment to anterior segment wound, or any retinal vein occlusion involving the macula.
    5. Atrophy/scarring/fibrosis involving the center of the macula, including evidence of laser treated atrophy within 200 microns of FAZ.
    6. Any subfoveal hard exudates, or RPE atrophy; or any present evidence, or past documentation of a foveal cyst (by fundus examination, FA or OCT).
    7. Subjects who have received panretinal photocoagulation, YAG laser, or peripheral retinal cryoablation (for retinal tears only), or focal or grid photocoagulation, within the previous 16 weeks, or more than one prior focal or grid laser.
    8. 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 1 year.
    9. Any intraocular surgery within 6 months of trial entry.
    10. Previous vitrectomy.
    11. HbA1C level ≥10% or recent signs of uncontrolled diabetes (3 or more episodes of severe hypoglycemia by DCCT (Diabetes Control and Complications Trial) definition [10] within 3 months of baseline, or 2 or more episodes of ketoacidosis within 1 year of baseline, or an episode of ketoacidosis within 3 months of baseline).
    12. Any of the following underlying systemic diseases including:
    History or evidence of severe cardiac disease, e.g. NYHA Functional Class III
    or IV, clinical or medical history of unstable angina, acute
    coronary syndrome, myocardial infarction, or revascularization procedure
    within 6 months prior to baseline, or ventricular tachyarrythmias requiring
    ongoing treatment.
    History (previous surgery or amputation), or evidence (symptoms of
    claudication) of clinically significant peripheral vascular disease.
    Clinically significant impaired renal function (serum creatinine >2.5 mg/dL or
    s/p renal transplant or receiving dialysis).
    Clinically significant impaired hepatic function.
    Stroke (within 12 months of trial entry).
    Any major surgical procedure within one month of trial entry
    13. Previous radiation to the head in the region of the study eye.
    14. Any prior treatment with an investigational agent for DME (including intravitreal, subconjunctival or subtenons corticosteroids) at any time, or during the past 90 days for any other condition.
    15. Known serious allergies to the fluorescein dye used in angiography, or to the components of pegaptanib sodium formulation.
    16. Systolic BP >160 (2 different readings) or diastolic BP >100 (2 different readings).
    17. Acute ocular or periocular infection.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be the proportion of subjects who experience a ≥ 15 letter (or 3-line) improvement in vision (ETDRS) from baseline. This endpoint will be assessed at 3 years to test the significance of the comparison of the proportions of 3-line improvement in each dose group versus sham. The 3 year endpoint is the primary endpoint, while the 1 and 2 year endpoints will be secondary endpoints. The primary endpoint will be tested in a stepwise fashion . An interim analysis (IA) will be performed by the Independent Data Safety Monitoring Committee (IDMC) in consultation with the independent holder of the database on all subjects who have completed the one year time point or have dropped out . The purpose of this IA is to determine if pegaptanib sodium is efficacious for subjects with DME after one year of therapy.
    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 Information not present in EudraCT
    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) 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 No
    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.8.5The 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
    150 weeks (3 years)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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 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 2006-03-08. 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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 340
    F.4.2.2In the whole clinical trial 900
    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 Decision2007-01-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-02-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-07-15
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