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    Summary
    EudraCT Number:2010-020946-80
    Sponsor's Protocol Code Number:A5751036
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-09-16
    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 ConcernedSweden - MPA
    A.2EudraCT number2010-020946-80
    A.3Full title of the trial
    A PHASE IIIB, ONE YEAR, OPEN LABEL, MULTICENTRE, NONCOMPARATIVE STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF INTRAVITREAL PEGAPTANIB SODIUM INJECTION IN SUBJECTS WITH DIABETIC MACULAR EDEMA (DME)
    A.4.1Sponsor's protocol code numberA5751036
    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.3.4Pharmaceutical 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.3.9.1CAS number 222716-86-1
    D.3.9.2Current sponsor codeEYE001
    D.3.9.3Other descriptive namePegaptanib sodium
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.3
    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
    Subjects with type I or type II diabetes with diabetic macular edema (DME) with
    proliferative or non proliferative diabetic retinopathy.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10057934
    E.1.2Term Diabetic macular edema
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to further evaluate the safety and tolerability of
    pegaptanib sodium in subjects with DME.
    E.2.2Secondary objectives of the trial
    No secondary objectives listed in the protocol.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be eligible for enrolment into the study:
    1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
    2. Subjects who are willing and able to comply with scheduled visits, treatment plan,
    laboratory tests, and other study procedures.
    3. Subjects with documented clinical diagnosis of diabetic macular edema (DME) with
    proliferative or non proliferative diabetic retinopathy.
    4. Subjects, who according to the clinical assessment of the investigator, may benefit from anti-VEGF therapy including those subjects who were participating in the A5751013 study and who, in the investigator’s opinion, may benefit from continued pegaptanib sodium therapy.
    5. Best corrected distance visual acuity in the study eye must be with a letter score between 78 and 24, inclusive (20/32 to 20/320 Snellen equivalents).
    6. Intraocular pressure of 21 mmHg, or less.
    7. The treating investigator 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.
    8. Type I or Type II diabetic subjects as defined by the WHO criteria, of either gender, and aged ≥18 years.
    9. Women must be using effective contraception or be post-menopausal for at least 12 months prior to trial entry, or surgically sterile. All women of childbearing potential
    must have a negative urine pregnancy test at baseline and negative urine pregnancy tests immediately prior to each injection and use an effective form of contraception during the trial and for at least 60 days following the last dose of pegaptanib sodium. Effective forms of contraception are: hormonal contraceptives (oral, injected, intrauterine, transdermal or implanted) or a double barrier contraception (ie condom plus spermicide in combination with a female condom, diaphragm, cervical cap or intrauterine device).
    10. Clear ocular media and adequate papillary dilatation.
    E.4Principal exclusion criteria
    Subjects presenting with any of the following will not be included in the study:
    1. Eyes with prior scatter (panretinal) photocoagulation within 4 months prior to baseline or anticipated scatter (panretinal) photocoagulation within the next 6 months.
    2. Any other condition which could contribute or cause macular edema such as vitreous extension, vitreomacular traction or entrapment to anterior segment wound, or any retinal vein occlusion involving the macula that could, in the investigator’s opinion, preclude benefit from pegaptanib sodium treatment.
    3. Atrophy/scarring/fibrosis involving the centre of the macula, including evidence of laser treated atrophy within 200 microns of foveal avascular zone (FAZ). Any known
    subfoveal hard exudates or retinal pigment epithelium (RPE) atrophy.
    4. Subjects who have received YAG laser, or peripheral retinal cryoablation, or laser
    retinopexy (for retinal tears only), or focal or grid photocoagulation, within the previous 16 weeks.
    5. Significant media opacities, including cataract, which might interfere with visual acuity and assessment of toxicity.
    6. Any intraocular surgery within 4 months of study entry.
    7. Previous vitrectomy.
    8. Previously documented HbA1C level >10% or recent signs of uncontrolled diabetes (3 or more episodes of severe hypoglycaemia 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).
    9. Known serious allergies to the components of pegaptanib sodium formulation.
    10. Subjects who have received either pegaptanib sodium or any other anti-VEGF agent and have not benefited from the treatment.
    11. Any of the following underlying diseases including:
    •History or evidence of severe cardiac disease eg. NYHA Functional Class III or IV
    (eg marked limitation of activity due to fatigue, palpitation or dyspnoea, or worse),
    myocardial infarction within 6 months, ventricular tachyarrythmias requiring ongoing
    treatment or unstable angina.
    •History of stroke within 12 months prior to baseline visit or evidence of clinically
    significant peripheral vascular disease such as intermittent claudication or prior
    amputation.
    •Acute ocular or periocular infection.
    12. Systolic BP > 160 (2 different readings) or diastolic BP > 100 (2 different readings).
    13. Subjects who have received any investigational drug or device within 3 months prior to the baseline visit except for those subjects that have participated in the A5751013 study and in the investigator’s opinion may benefit from continued pegaptanib sodium therapy.
    14. Other known severe acute or chronic medical or psychiatric condition or laboratory abnormality (in particular known laboratory abnormalities that may indicate impaired renal or hepatic function) that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint:
    • The incidence of AEs both ocular and non-ocular.
    Secondary endpoints:
    • The incidence of SAEs both ocular and non-ocular.
    • Mean total number of injections per subject.
    • Mean changes in BCVA from baseline to end of treatment.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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 No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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
    As per protocol
    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 days18
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days18
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 500
    F.4.2.2In the whole clinical trial 500
    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)
    Subject will be given ‘country-specific’ standard of care at the end of the trial.
    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 Decision2010-10-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-06-28
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