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    Summary
    EudraCT Number:2019-002067-10
    Sponsor's Protocol Code Number:BP41321
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-07-17
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2019-002067-10
    A.3Full title of the trial
    A randomized, double-masked, 48-week parallel-group, placebo-controlled, proof-of-concept study to investigate the efficacy and safety of RG7774 in patients with Diabetes Mellitus Type 1 or Type 2 with treatment-naïve diabetic retinopathy.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Investigate the Efficacy and Safety of RG7774 in Patients with Diabetes Mellitus Type 1 or Type 2 with Treatment-naïve Diabetic Retinopathy
    A.3.2Name or abbreviated title of the trial where available
    CANBERRA
    A.4.1Sponsor's protocol code numberBP41321
    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 SponsorF. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    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 supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 nameRG7774
    D.3.2Product code RG7774/F08
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRG7774
    D.3.9.2Current sponsor codeRG7774
    D.3.9.3Other descriptive nameRO6868847
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) 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 No
    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.3.1Product nameRG7774
    D.3.2Product code RG7774/F04
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRG7774
    D.3.9.2Current sponsor codeRG7774
    D.3.9.3Other descriptive nameRO6868847
    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 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) 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 No
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment-naïve Diabetic retinopathy
    E.1.1.1Medical condition in easily understood language
    Diabetic retinopathy is a medical condition in which damage occurs to the retina due to diabetes mellitus (DM).
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10012689
    E.1.2Term Diabetic retinopathy
    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
    • Assess the effect of RG7774 on the severity of diabetic retinopathy
    • Evaluate the safety and tolerability of RG7774
    E.2.2Secondary objectives of the trial
    • Assess the effect of RG7774 on progression to vision-threatening DR
    • Assess the effect of RG7774 on visual acuity
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age >= 18 years
    Ocular Criteria for study eye:
    • Patients with treatment naïve, moderately severe to severe Non-proliferative DR (NPDR) defined as Early Treatment Diabetic Retinopathy Study (ETDRS) DR severity score (DRSS) 47 or 53
    • Patients are eligible with and without Diabetic Macular Edema (DME) in either eye, defined as the presence of signs in the macula such as swelling, leakage, exudates, cystoid changes and fluid. In addition, Central Subfield Thickness (CST) on SD OCT needs to be  300µm to confirm diagnosis of DME
    • If present, DME has to be treatment-naïve and not expected to require treatment during the duration of the study in the opinion of the investigator at screening and Day 1
    • Best corrected visual acuity (BCVA) score at screening of at least 70 letters in study eyes without DME and at least 75 letters in case DME is present, using ETDRS visual acuity testing charts at a testing distance of 4 meters
    • Clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images
    General Criteria:
    • Diagnosis of DM type 1 or type 2, as defined by the World Health Organization and/or American Diabetes Association
    • HbA1c <= 10%
    • Allowed existing medication regimens should be stable for at least 6 weeks before screening, with the intent to remain stable throughout the study.
    • Patient is willing to refrain from cannabinoid use for the entire duration of the study
    • Women of child-bearing potential who are not pregnant or breastfeeding, agree to remain abstinent or use of two non-hormonal highly effective contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 4 weeks after the final dose of RG7774 or placebo
    • Male participants, during the treatment period and for at least 90 days after the final dose of study treatment, agree to and remain abstinent or use barrier contraceptive measures such as a condom plus an additional contraceptive method and refrain from donating sperm for at least 90 days
    • In the Investigator’s opinion, the subject is deemed appropriate for participation in the study, capable of following the study schedule of assessments and complying with the study restrictions and participation in the study or discontinuation of prohibited medication will not pose undue risks to the participant.
    E.4Principal exclusion criteria
    Ocular criteria for Study eye:
    -Prior treatment for DR or other retinal diseases with an approved or
    investigational therapy, including but not limited to intravitreal steroids,
    intravitreal anti-VEGF, light therapy, and laser or any intravitreal anti-
    Vascular endothelial growth factor (VEGF) or steroid.
    -Prior periocular pharmacological intervention for other retinal diseases
    within 6 months prior to screening.
    -Intraocular surgery less than 3 months prior to screening
    -Aphakia or implantation of intraocular lens outside of the capsular bag
    -History of vitreoretinal surgery
    -Uncontrolled glaucoma
    -Amblyopia
    -Any history of idiopathic or immune-mediated uveitis in either eye
    -Any concurrent intraocular condition that in the opinion of the
    Investigator could reduce the potential for improvement, require medical
    surgical intervention or may confound the visual and functional
    assessment and interpretation of study results
    Concurrent ocular conditions in either eye:
    -Any active ocular infection.
    -Any active intraocular inflammation.
    General Criteria:
    -Previous systemic use of anti-VEGF drugs within 6 months prior to
    screening
    -Complications of DM such as end-stage renal disease or liver disease
    -Currently untreated DM or previously untreated patients who initiated
    oral or injectable anti-diabetic medication within 3 months prior to
    screening.
    -Uncontrolled blood pressure
    -Confirmed clinically significant abnormality on ECG at screening.
    -History of concurrent cardio-vascular disease not considered well
    controlled by the investigator
    -Positive serology results for hepatitis B virus (HBV), hepatitis C virus
    (HCV), HIV-1, HIV-2
    -Any major illness or major surgical procedure within one month before
    screening.
    -History of or currently active other diseases, viral and/or bacterial
    infections, metabolic dysfunction, physical examination finding, and
    malignancies not considered cured, or clinical laboratory findings giving
    reasonable suspicion of a condition that contraindicated the use of the
    investigational medicinal drug or that might affect interpretation of the
    results of the study or renders the patient at high risk for treatment
    complications in the opinion of the investigator. Participants who tested
    positively for COVID-19/SARS-CoV-2 at any time prior to Day 1 are
    excluded. This applies to all participants regardless of their vaccination
    status and regardless of presence of COVID-19 symptoms.
    -Known hypersensitivity to any of the excipients of the drug used,
    fluorescein dye or dilating eye drops
    -Alcohol and/or substance abuse/dependence during the last 12 months
    -Use of systemic medications known to be toxic to the lens, retina or
    optic nerve used during the 6-month period prior to screening or likely
    need to be used.
    -Participation in a clinical study involving an investigational product or
    device with exit from that study within 60 days prior to screening, or
    within less than 5 half-lives (whichever is longer) between last exposure
    to study treatment in the previous study and screening for the present
    study
    E.5 End points
    E.5.1Primary end point(s)
    1. Proportion of participants with >= 2 step improvement in the Early Treatment Diabetic Retinopathy Study DR severity score from baseline at Week 36 measured in the study eye
    2. Frequency and severity of adverse events
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Baseline (Day 1) to Week 36
    2. Up to 52 weeks
    E.5.2Secondary end point(s)
    1. Incidence of anterior segment neovascularization, new proliferative diabetic retinopathy (PDR), new DME, and pre-existing DME requiring intervention
    2. Change from baseline in best corrected visual acuity at Week 36 in the study eye
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Up to 52 weeks
    2. Baseline to Week 36
    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 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) 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 trial3
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    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
    United States
    Poland
    Portugal
    Slovakia
    Spain
    United Kingdom
    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
    The end of study is defined as last visit of the last participant. The last participant last observation (LPLO) is expected to occur 48 weeks after the last participant is enrolled.
    Participants are considered to have completed the study if they have completed all the assessments as required in this 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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    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: 128
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 135
    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)
    The Sponsor does not intend to provide RG7774 or other study interventions to participants after conclusion of the study or any earlier participant withdrawal
    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 Decision2020-09-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-08-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-07-19
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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
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