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    The EU Clinical Trials Register currently displays   43846   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2008-000349-68
    Sponsor's Protocol Code Number:B0451004
    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:2008-06-17
    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 ConcernedUK - MHRA
    A.2EudraCT number2008-000349-68
    A.3Full title of the trial
    A PHASE II PROSPECTIVE, RANDOMIZED, MULTI-CENTER, DIABETIC MACULAR EDEMA DOSE RANGING, COMPARATOR STUDY EVALUATING THE EFFICACY AND SAFETY OF PF-04523655 VERSUS LASER THERAPY (DEGAS)
    A.4.1Sponsor's protocol code numberB0451004
    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. 235 East 42nd Street, New York NY10017
    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 No
    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.3.2Product code PF-04523655
    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.3.9.2Current sponsor codePF-04523655
    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 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.IMP: 2
    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 No
    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.3.2Product code PF-04523655
    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.3.9.2Current sponsor codePF-04523655
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    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
    To evaluate efficacy of three dose levels of PF-04523655 versus laser in improving visual acuity in subjects with diabetic macular edema .
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of PF-04523655 in subjects with diabetic
    macular edema.
    • To evaluate the dosing schedule in maintaining the effect of PF-04523655 in subjects with diabetic macular edema.
    • To evaluate changes in lesion morphology following administration of PF-04523655
    by fundus photography, fluorescein angiography (FA) and optical coherence
    tomography (OCT).
    • To evaluate the efficacy of PF-4523655 on vision related function and well being
    assessed using the National Eye Institute Visual Function Questionnaire-25 (NEIVFQ-
    25)
    • To evaluate systemic exposure of PF-04523655 at 1 week following first dose.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. History of diabetes mellitus (Type 1 or Type 2).
    2. Serum HbA1c ≥5.5% and ≤12% at the screening visit.
    3. Subjects with diffuse diabetic macular edema consisting of retinal thickness on OCT measuring 275 µm or more in the central subfield at the screening visit.
    4. Reduced visual acuity resulting from retinal thickening involving the center of the fovea and a best corrected visual acuity, using Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity protocol of 20/40 or worse (letter score of ≤73) and up to 20/320 or better (letter score ≥24) in the study eye at the screening visit.
    5. Visual acuity score in the fellow eye of 20/400 or better (letter score of ≥19) at the screening visit.
    Note: Only one eye will be treated (study eye), in the event both eyes are eligible for study entry the study eye should be selected by the investigator and subject.
    6. Treatment for diabetic macular edema with laser photocoagulation can be withheld for at least 90 days after the subject has enrolled in the study.
    7. Ocular media and adequate pupillary dilation to allow good quality OCT and stereoscopic fundus photography.
    8. 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.
    9. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures such as telephone access from Call Center for the administration of NEI-VFQ-25
    10. Males and females aged 18 years or older. Female subjects either of non-childbearing potential (hysterectomized or believed to be post-menopausal as evidenced by a 3 year history of amenorrhea) or of childbearing potential are eligible, provided they have a negative urine pregnancy test at the Screening and Baseline visit. Female subjects of childbearing potential should be willing to use adequate (at least two forms of) contraceptive methods as described below during the treatment period and for 3 months after the last dose of study medication. Male subjects with partners of childbearing potential must agree to use adequate (at least one form of) contraception as described below during the treatment period and for 3 months after the last dose of study medication or be surgically sterile.
    Acceptable contraceptive methods for male (need at least one):
    a. Abstinence;
    b. Use of condom for males with a vasectomy;
    c. Without a vasectomy, must use a condom and be instructed that their female
    partner should use another form of contraception such as an IUD, spermicidal
    foam/gel/film/cream/suppository, diaphragm with spermicide, oral contraceptive,
    injectable progesterone, subdermal implant or tubal ligation if the female partner
    could become pregnant from the time of the first dose of trial medication until
    3 months after the last dose.
    Acceptable contraceptive methods for female (need at least two):
    a.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;
    b.Abstinence;
    c.Placement of a copper-containing intrauterine device (IUD);
    d.Condom with spermicidal foam/gel/film/cream/suppository;
    e.Tubal ligation;
    f.Male partner who has had a vasectomy for at least 4 months
    E.4Principal exclusion criteria
    1.Panretinal photocoagulation or macular photocoagulation performed in the study eye within 3 months of the screening visit.
    2.Subjects receiving concomitant intravitreal anti-VEGF therapy in the non study eye. Intravitreal steroids in the non study eye are permitted.
    3.Any concurrent intraocular condition in the study eye or previous surgery (eg, cataract, vitrectomy) that, in the opinion of the investigator, could either (a) require medical or surgical intervention during the 36-month study period to prevent or treat visual loss that might result from that condition, or (b) if allowed to progress untreated, could likely contribute to loss of at least 2 ETDRS lines of best corrected visual acuity over a 36-month period (c) may affect macular edema or reduce visual acuity during the course of the study eg, uveitis/ ocular inflammatory disease, vein occlusions, Irvine-Gass syndrome.
    4.Cataract surgery in the study eye within 2 months prior to study enrollment.
    5.High risk proliferative diabetic retinopathy (PDR) in the study eye. Inactive fibrosed neovascularization following pan retinal photocoagulation (PRP) laser therapy and non high risk PDR with no evidence of vitreous hemorrhage is permitted.
    6.Current infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.
    7.Aphakia or absence of the posterior capsule in the study eye. Previous Yttrium Aluminum Garnet (YAG) capsulotomy performed 2 months or more prior to study entry associated with posterior intraocular lens implant is permitted.
    8.Structural damage to the center of the macula in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema, including but not limited to persistent DME involving the foveal center of more than 2 years in duration, atrophy of the retinal pigment epithelium, subretinal fibrosis, macular ischemia as defined by an enlarged foveal avascular zone (FAZ >1000μm on fundus fluorescein angiography), laser scar(s), organized hard exudative plaque, vitreomacular traction, epiretinal membrane evident on ophthalmic examination or by OCT.
    9.Uncontrolled glaucoma (defined as intraocular pressure treatment with anti-glaucoma medications) with IOP 30 mm Hg and/or advance disc cupping with glaucomatous visual field loss.
    10.Subjects who have a history of any severe acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, could make the subject inappropriate for entry into this study; eg,;
    •History of gastrointestinal bleeding within 2 months of study enrollment;
    •Renal function insufficiency: serum creatinine >2.5 mg/dL or status post renal transplant or receiving dialysis;
    •liver function insufficiency: serum bilirubin >1.5 mg/dL, ALT >2 x ULN, AST > 2 x ULN, alkaline phosphatase > 2 x ULN;
    •History or evidence of severe cardiac disease (NYHA Functional Class III or IV) (Appendix 6), medical history of cerebral vascular accident, unstable angina, acute coronary syndrome, transient ischemic attacks, myocardial infarction, revascularization procedure within 6 months prior to screening visit, or ventricular tachyarrythmias requiring ongoing treatment;
    •History or evidence of clinically significant peripheral vascular disease such as intermittent claudication or prior amputation;
    •Stroke within 12 months of baseline visit;
    •History of procedure/surgery with increased risk of thromboembolism such as but not limited to major gastrointestinal, cardiothoracic, gynecological, genitourinary, or orthopedic surgeries within 2 months of study enrollment;
    •Poor glycemic control expected to require initiation of insulin treatment within the next 4 months from baseline should not be enrolled into the study.
    11.Subjects with blood pressure >180/110 at screening visit should be excluded. Subjects with blood pressure equal or below 180/110 with anti-hypertensive medication may be enrolled into the study.
    12.Subjects who show a clinically significantly abnormal ECG, suggesting ischemic heart diseases, clinically significant cardiac arrhythmias, atrioventricular block, congestive heart failure as determined by a physician at screening. In case a clinically significant abnormality is shown at screening, the ECG should be assessed at baseline again to determine the eligibility.
    E.5 End points
    E.5.1Primary end point(s)
    Mean change from baseline (Day 0) at Month 24 in the best corrected visual acuity
    (BCVA) score, as measured by ETDRS visual acuity protocol.
    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 Information not present in EudraCT
    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 Yes
    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) No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Information not present in EudraCT
    E.8.1.3Single blind Yes
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Laser photocoagulation
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months36
    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 months36
    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.1.1.1In 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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 160
    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 Decision2008-07-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-11-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2010-12-17
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