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    Summary
    EudraCT Number:2012-000823-42
    Sponsor's Protocol Code Number:B1181003
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-07-08
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2012-000823-42
    A.3Full title of the trial
    A PHASE 2 MULTI-CENTER, RANDOMIZED, DOUBLE-MASKED, PLACEBO CONTROLLED, MULTI-DOSE STUDY TO INVESTIGATE THE EFFICACY, SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF RN6G (PF 04382923) IN SUBJECTS WITH GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to investigate the efficacy and safety of treatment with RN6G in patients with age related macular degenerateion resulting in age-related loss of central vision.
    A.3.2Name or abbreviated title of the trial where available
    B1181003 Clinical Study of RN6G (PF-04382923)
    A.4.1Sponsor's protocol code numberB1181003
    A.5.4Other Identifiers
    Name:US IND Number Number:102691
    A.7Trial is part of a Paediatric Investigation Plan No
    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, NY 10017
    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 supportPfizer Inc., 235 East 42nd Street, New York, NY 10017
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 E 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18007181021
    B.5.5Fax number+13037391119
    B.5.6E-mailClinicalTrials.govCallCenter@pfizer.com
    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.3.1Product nameRN6G
    D.3.2Product code PF-04382923
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codePF-04382923
    D.3.9.3Other descriptive nameRN6G
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection/infusion
    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
    Advanced, Dry, Age-Related Macular Degeneration including Geographic Atrophy
    E.1.1.1Medical condition in easily understood language
    A progressive loss of vision in your central visual field (what’s in front of you not to the sides) due to damage of the retina.
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10064930
    E.1.2Term Age-related macular degeneration
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the efficacy of RN6G in subjects with geographic atrophy in the study eye.
    E.2.2Secondary objectives of the trial
    • To examine retinal structural and functional deficits with ocular assessments for the study and the fellow eye.
    • To examine the safety, tolerability and immunogenicity of RN6G in subjects.
    • To characterize the population pharmacokinetic (PK) profile of RN6G.
    • To demonstrate the effect of RN6G on plasma Aß(1-x)(total), Aß(1-40) and Aß(1-42) concentrations.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men and women between the ages of 60 and 90 years, inclusive.
    2. Diagnosis of a well demarcated area of geographic atrophy (GA) secondary to dry AMD.
    One eye (designated as the study eye) must have the following for AREDS AMD Levels Defined for Eyes):
    • 3d: Geographic atrophy within grid but none at the center of the macula.
    • 4a: Geographic atrophy in central subfield with at least questionable involvement of center of macula.

    The other eye (designated as the fellow eye) can have Level 3 or 4a AMD. If both eyes have Level 3d or 4a AMD, then
    the eye with the best BCVA would be considered the study eye; otherwise it should be considered the fellow eye. If
    the ETDRS BCVA is the same in each eye, then the Investigator will designate the study and fellow eye.

    A subject will be excluded from study if the fellow eye has Level 4b and has been or is currently being treated with anti
    VEGF therapy.

    The determination of AREDS AMD Levels will be made by a Central Reader.
    3. GA total area between 2.0 and 17.5 mm2.
    4. Best corrected visual acuity (BCVA) of ≥54 letter (20/80 (Snellen VA equivalent) or better in the study eye as
    determined using an ETDRS chart.
    5. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal
    representative) has been informed of all pertinent aspects of the study.
    6. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study
    procedures.
    E.4Principal exclusion criteria
    Any disease or condition that might compromise the cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, central nervous, immune, or gastrointestinal systems (unless deemed not clinically significant by the Investigator and Sponsor) such as, but not limited to:
    a. Diagnosis or history of Alzheimer’s disease, dementia of any cause such as untreated thyroid disease or stroke or neuro degenerative disorders (eg, Parkinson’s disease, Lewy body disease, fronto temporal dementia, vascular dementia);
    b. History or systemic signs of inflammatory bowel disease, multiple sclerosis, systemic lupus erythematosus;
    c. History of cancer within the last 5 years (except for cutaneous basal cell or squamous cell cancer resolved by excision);
    d. Presence of uncontrolled hypertension (uncontrolled hypertension is defined as a systolic blood pressure greater than 140 mm Hg or a diastolic blood pressure greater than 90 mm Hg, even with treatment). Subjects who have hypertension and are controlled on stable dosages of anti hypertensive medications can be included;
    e. Poorly controlled Type 1 and Type 2 diabetes mellitus (HbA1c >9%). HbA1c must be obtained only for subjects with a known diagnosis of diabetes.

    History or diagnosis of ocular disease other than advanced dry AMD or GA in the study eye that would confound the results of the study, such as diabetic retinopathy with microhemorrhage, uveitis (CTCAE Grade ≥2), or pseudovitelliform macular degeneration.

    History or diagnosis of exudative (wet) AMD, with subretinal or choroidal neovascular lesions in the study or fellow eye.

    History of ocular infection, ocular inflammation or laser or cataract surgery within 3 months of Day 1.

    History of ocular trauma or surgery (other than laser or cataract surgery) within 6 months of Day 1.

    History of laser photocoagulation in the study eye.

    Presence of ocular lens opacities preventing vision testing: cortical opacity greater than standard 3, posterior subcapsular opacity greater than standard 2, or a nuclear opacity greater than standard 3 (as measured on the AREDS clinical lens grading system).

    History of optic amblyopia, glaucoma, optic nerve or other retinal disease or dysfunction (eg, disorders leading to or associated with retinal detachment, macular edema, atrophic retinal holes, retinal tears, retinal detachment, exudative retinal detachment, retinal toxicities due to medications, retinitis pigmentosa). Subjects with cobblestone or paving stone peripheral retinal degeneration are acceptable.

    Subjects expected to need ocular surgery during the study.
    E.5 End points
    E.5.1Primary end point(s)
    The mean reduction in the rate of growth of GA area (in mm2) at 30 days post last dose administration (Day 309) and at end of study with FAF.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The mean reduction in the rate of growth of GA area (in mm2) at 30 days post last dose administration (Day337)
    E.5.2Secondary end point(s)
    BCVA
    • The mean BCVA letter number and line number after RN6G at 9, 12, 15 months and end of study compared to baseline and placebo.
    • The mean percentage change from baseline in the correct number of letters after RN6G at 9, 12, 15 months and end of study.
    • The mean percentage change from baseline in the correct number of lines after RN6G at 9, 12, 15 months and end of study.

    Low Luminance (LL) BCVA
    • The mean LL BCVA letter number and line number after RN6G at 9, 12, 15 months and end of study compared to baseline and placebo.
    • The mean percentage change from baseline in the correct number of letters after RN6G at 9, 12, 15 months and end of study.
    • The mean percentage change from baseline in the correct number of lines after RN6G at 9, 12, 15 months and end of study.

    Contrast Sensitivity
    • The mean change in Logmar units compared to baseline and placebo at 9, 12, 15 months and end of study.
    • The percentage change from baseline in Logmar units at 9, 12, 15 months and end of study.

    Reading
    • The mean reading acuity and speed change from baseline at 9, 12, 15 months and end of study.
    • The mean reading acuity and speed change from placebo at 9, 12, 15 months and end of study.
    • The mean critical print size change from baseline and placebo at 9, 12, 15 months and end of study.
    • The percentage change from baseline in reading acuity and speed at 9, 12, 15 months and end of study.

    Safety
    • Incidence, severity and causal relationship of treatment emergent AEs (TEAEs).
    • Incidence of abnormal and clinically relevant safety laboratories including clinical chemistry, hematology and coagulation assessments.
    • Abnormal and clinically relevant changes in vital signs, BP, and ECG parameters.
    • Incidence of anti-drug-antibodies.

    Pharmacokinetics
    • Plasma RN6G concentrations at specified time points and population PK parameter estimates for AUCτ, Cmax, Cmin, CL at steady state, and accumulation ratio on AUCτ between the first and last (11th) doses.

    Pharmacodynamics
    • Change from baseline (absolute and %) of plasma Aβ(1-x) (total), Aβ(1-40) and Aβ(1-42) concentrations.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) The mean BCVA letter number and line number after RN6G at 9, 12, and 15 months compared to placebo.
    2) The mean percentage change from baseline in the correct number of letters after RN6G at 9, 12 and 15 months.
    3) The mean percentage change from baseline in the correct number of lines after RN6G at 9, 12, and 15 months
    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 Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    Germany
    Italy
    Spain
    United Kingdom
    United States
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    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 days0
    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.1.2.1Number of subjects for this age range: 28
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 248
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 276
    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)
    expected normal treatment of that condition
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-11-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-18
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-04-10
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