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    Summary
    EudraCT Number:2006-001182-41
    Sponsor's Protocol Code Number:C0168X97
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-11-24
    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 ConcernedGreece - EOF
    A.2EudraCT number2006-001182-41
    A.3Full title of the trial
    Infliximab for Diabetic Macular Edema Refractory to Laser Photocoagulation: a Randomized, Double-Masked, Placebo-Controlled, Cross-over, 32 Weeks Study
    A.4.1Sponsor's protocol code numberC0168X97
    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 SponsorAss.Prof. Petros Sfikakis
    B.1.3.4CountryGreece
    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 Remicade
    D.2.1.1.2Name of the Marketing Authorisation holderCentocor B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameRemicade
    D.3.2Product code cA2
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNInfliximab
    D.3.9.3Other descriptive nameAnti-(human tumor necrosis factor) immunoglobulin G (human-mouse monoclonal cA2 heavy chain)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typemonoclonal antibody
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for suspension for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diabetic Macular Oedema
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10057915
    E.1.2Term Diabetic macular oedema
    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 the study is to assess the efficacy and safety of infliximab on the best corrected visual acuity (BCVA) after 4 infusions infliximab in patients with clinically significant DME (i.e. visual loss lower than 0.4 due to diffuse or focal DME) which is refractory to laser photocoagulation.
    E.2.2Secondary objectives of the trial
    Secondary endpoints include the effect of infliximab on anatomical improvement of DME (reduction of macular thickness), and on diabetic retinopathy. In addition, the effect of infliximab on plasma inflammatory markers in all participants, and on insulin sensitivity and beta-cell function in patients with type 2 diabetes will be examined.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients will be eligible for enrolment in the study (Visit 0) and for randomization (Visit 1) if they fulfil the following criteria:
    1. Have the capacity to understand and sign an informed consent form.
    2. Signed informed consent (must be obtained before any specific procedure is performed).
    3. Presence of clinically significant macular edema, with visual acuity less than 0.4 corrected to EDRS scale, which is refractory to at least two sessions of laser photocoagulation, defined as:
    A. Thickening of the retina at or within 500 μm of the center of the macula.
    B. Hard exudates at or within 500 μm of the center of the macula, if associated with thickening of the adjacent retina.
    C. A zone or zones of retinal thickening 1 disc area or larger, any part of which is within 1 disc diameter of the center of the macula.

    4. Male or female aged 18-80 years, inclusive.
    5. Type 1 or type 2 diabetes of at least 1 year duration. Type 1 diabetes is defined clinically as a diagnosis made before the age of 36 years with a continuous need for insulin within a year of diagnosis. Type 2 diabetes is defined clinically as a diagnosis made at age of 36 or above without a need for continuous insulin therapy within a year of diagnosis.
    6. Postmenopausal women (no menstrual cycle for a period of a minimum of 1 year) or surgically sterilized and have a negative serum pregnancy test on entry in the study. Men must agree to use adequate birth control during the study for 6 months after the infusion of the study agent.
    7. Men and women of childbearing potential must use adequate birth control measures (e.g. abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, implantable or injectable contraceptives or surgical sterilization) for the duration of the study and should continue such precautions for 6 months after receiving the last infusion.
    8. Stable diabetic therapy within the last 6 months, i.e. absence of major change in glycemic control (e.g. 2% change in HbA1c) or change in daily number of insulin injections.
    9. HbA1c 6.2-10%.
    11. The screening laboratory test must meet the following criteria: white blood cell count >5x10/L; absolute neutrophil count >1x10/L; platelet count >50x10/L; haemoglobin >100 g/L; serum creatinine <2 mg/dl; aspartate aminotransferase < 3 times the upper normal limit; alanine aminotransferase <3 times the upper normal limit; alkaline phosphatase < 2 times the upper normal limit, γ-GT< 2 times the upper normal limit
    12. Patients are considered eligible according to the following tuberculosis (TB) screening criteria:
    A) Have no history of latent or active TB prior to screening.
    B) Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination.
    C) Have had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB prior to or simultaneously with the first administration of study agent.
    D) Within 1 month prior to the first administration of study agent, either have a negative tuberculin skin test, as outlined in appendix B, or have a newly identified positive tuberculin skin test during screening in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated either prior to or simultaneously with the first administration of study agent.
    E) Have a chest radiograph (both posterior-anterior and lateral views), taken within 3 months prior to the first administration of study agent and read by a qualified radiologist, with no evidence of current active TB or old inactive TB.
    E.4Principal exclusion criteria
    Patients will be excluded from enrolment into the study if they fulfil any of the following criteria:
    1. Vitreoretinal traction.
    2. Retinal detachment.
    3. Proliferative diabetic retinopathy requiring immediate panretinal photocoagulation.

    4. Any previous eye surgery in the last 6 months before the beginning of the study (intravitreal injections are not considered ocular surgery).

    5. Macular Edema of ischaemic type.
    6. Macular Edema caused by retinal conditions other than diabetes.
    7. Cataract or media opacities of a degree which precludes accurate retinal photographs or OCT measurement.
    8. Hard exudates under the fovea.
    9. Uncontrolled hypertension (blood pressure above 180/110 mmHg).
    10. Angle closure glaucoma which precludes pharmacological dilatation of the pupil.
    11. Use in the previous 6 months of oral corticosteroids or in the previous month of anti-inflammatory medication.
    12. Women who are pregnant, nursing, or planning pregnancy within 6 months after the last infusion) (this includes fathers who plan on fathering a child within 6 months after their last infusion).
    13. Have had any previous treatment with monoclonal antibodies or antibody fragments.
    14. History of receiving human/murine recombinant products or a known allergy to murine products. A known allergy to murine product is definitely an exclusion criterion.
    15. Documentation of seropositivity for human immunodeficiency virus (HIV).
    16. A positive test for hepatitis B surface antigen or hepatitis C virus (HCV).
    17. Have a history of alcohol or substance abuse within the preceding 6 months that, in the opinion of the investigator, may increase the risks associated with study participation or study agent administration, or may interfere with interpretation of the results.
    18. Have a known history of serious infections (e.g. hepatitis, pneumonia, or pyelonephritis) in the previous 3 months.
    19. Have or have had an opportunistic infection (e.g. herpes zoster, cytomegalovirus, Pneumocustis carinii, aspergillosis, histoplasmosis, or mycobacteria other than tuberculosis) within 6 months prior to screening.
    20. Have a chest radiograph at screening that shows evidence of malignancy, infection, or any abnormalities suggestive of TB.
    21. Have a history of lymphoproliferative disease, including lymphoma or signs suggestive of possible lymphoproliferative disease such as lymphadenopathy of unusual size or location (e.g. nodes in the posterior triangle of the neck, infraclavicular, epitrocheal, or periaortic area), or splenomegaly.
    22. Currently have a known malignancy or have a malignancy within the previous 5 years, with the exception of basal or squamous cell carcinoma of the skin that has been fully excised with no evidence of recurrence.
    23. Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological or cerebral disease.
    24. Are unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access.
    25. Use of any investigational drug within 6 months prior to screening.
    26. Presence of transplanted solid organ (with the exception of corneal transplant > 3 months prior to screening).
    27. Have a concomitant diagnosis or history of congestive heart failure.
    28. Blood donation for the duration of the study
    29. Have allergy or other contraindication to fluorescein.
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of the study is to assess the efficacy and safety of infliximab on the best corrected visual acuity (BCVA) after 4 infusions infliximab in patients with clinically significant DME (i.e. visual loss lower than 0.4 due to diffuse or focal DME) which is refractory to laser photocoagulation.
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Yes
    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 Yes
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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
    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 months6
    E.8.9.1In the Member State concerned days
    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 Information not present in EudraCT
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state26
    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 Decision2007-01-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-03-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-10-09
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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