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    Summary
    EudraCT Number:2007-006795-10
    Sponsor's Protocol Code Number:FPH-Macugen08
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-07-15
    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 ConcernedUK - MHRA
    A.2EudraCT number2007-006795-10
    A.3Full title of the trial
    A randomised controlled trial of efficacy of Pegaptanib sodium in the prevention of proliferative diabetic retinopathy
    A.3.2Name or abbreviated title of the trial where available
    EPPPDR
    A.4.1Sponsor's protocol code numberFPH-Macugen08
    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 SponsorFrimley Park Hospital NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    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 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 Ltd
    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
    D.3.9.1CAS number 222716-86-1
    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
    Diabetic Retinopathy
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10054109
    E.1.2Term Non-proliferative diabetic retinopathy
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This study is designed to evaluate the safety and explore the effects of Macugen in eyes with severe non proliferative diabetic retinopathy(ETDRS 53A-E).The objective of the study is to assess whether Macugen given at these time points of diabetic retinopathy can prevent the conversion to sight threatening proliferative diabetic retinopathy.
    E.2.2Secondary objectives of the trial
    1. 1. The proportion of eyes that progress to ETDRS ≥61 or above following three injections of intravitreal Macugen compared to control eyes receiving standard care (no treatment) at 24 months.
    2. The rate (time point) of development of neovascularisation in treated eyes will be compared to control eyes.
    3. Rates of ocular and non-ocular adverse events.
    4. The visual outcome in the study eye will be compared to control eyes
    5. The mean change in size of FAZ from baseline to end of 12 months and 24 months in treated eyes will be compared to control eyes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1)TypeI or Type II Diabetes

    2)Serum HbA1C >5.5% and <12% at screening visit

    3)ETDRS 53 A_E. 61,65

    4)BCVA letter score in study eye < 80 using an ETDRS chart measured at 4 meters distance

    5)BCVA letter score in fellow eye of >19 letters

    6)Male or female patients at least 18 years of age. Female subjects either of non child bearing potenial (hysterectomised or believed to be post menopausal as evidenced by a three yera history of amenorrhoea) or of cild bearing age are eligible, provided they have a negative urinary pregnancy test at the screening and baseline visit. Female subjects of child bearing potential should be willing to use adequate (atleast to forms of) contraceptive methods as described below during the treatment period and for three months after the last dose of study medication. Male subjects with partners of child bearing potential must agree to use adequate (at least one form of) contaception as described below during the treatment period and for three months after the last dose of study medication or be surgically sterile.
    Acceptable contraceptive methods for female (need at least two)

    • Hormonal methods of contraception (including oral and transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone- releasing IUDs) at least 14 days prior to the first dose of trial medication
    • Abstinence
    • Placement of a copper containing device
    • Condom with spermicidal foam / gel film/ cream/ suppository
    • Tubal ligation
    • Male partner who has had a vasectomy for at least 4 months

    Acceptable contraceptive methods for male (need at least one)

    • Abstinence
    • Use of condoms for males with a vasectomy
    • Without a vasectomy, must use a condom and be instructed that their female partner should use another form of contraception such as IUD, spermicidal foam/ gel/cream/suppository, diaphragm with spermicide, oral contraceptive, injectable progesterone, subdermal implant or tubal ligation if the female partner could become pregnant from the first dose of medication until three months after the last dose.

    7) Patients who provide written and informed consent according to legal requirements, and who have signed the consent form prior to initiation of any study procedure
    E.4Principal exclusion criteria
    1) Active intraocular or periocular inflammation

    2) History of intraocular surgeries within the last 2 months in the study eye

    3) Current treatment with any other investigational product

    4) Retinal vascular diseases

    5) Uncontrolled glaucoma (With antiglaucoma medications intraocular pressure more than 30 mmof Hg and or advanced disc cupping with glaucomatous field loss)

    6) Planned or anticipated need for cataract surgery during the 12month study period

    7) Pregnant or lactating women

    8) Other retinal diseases that might affect the outcome (except diabetic maculopathy)

    Others
    • Allergy to FFA

    • Allergy to Iodine

    • Inability to obtain colours, fluorescein angiography of sufficient quality.

    • Allergy to anti VEGF medications.

    • Allergy to humanised monoclonal antibody.

    • Inability to comply with follow up procedures
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of eyes that progress to ETDRS ≥61 following three injections of intravitreal Macugen compared to control eyes receiving standard care (no treatment) at 12 months.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    standard care
    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 EEA2
    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
    The proportion of eyes that progress to ETDRS ≥61 or above following three injections of intravitreal Macugen compared to control eyes receiving standard care (no treatment) at 24 months.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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 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 state90
    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 Decision2008-08-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-08-01
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2011-06-07
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