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    Summary
    EudraCT Number:2015-003079-31
    Sponsor's Protocol Code Number:QRK207
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-07-21
    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 ConcernedGermany - BfArM
    A.2EudraCT number2015-003079-31
    A.3Full title of the trial
    A PHASE 2/3, RANDOMIZED, DOUBLE-MASKED, SHAMCONTROLLED TRIAL OF QPI-1007 DELIVERED BY SINGLE
    OR MULTI-DOSE INTRAVITREAL INJECTION(S) TO SUBJECTS WITH ACUTE NONARTERITIC ANTERIOR ISCHEMIC OPTIC NEUROPATHY (NAION)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A TRIAL OF QPI-1007 DELIVERED BY SINGLE OR MULTI-DOSE INTRAVITREAL INJECTION(S) TO SUBJECTS WITH ACUTE OPTIC NEUROPATHY (NAION)
    A.4.1Sponsor's protocol code numberQRK207
    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 SponsorQuark Pharmaceuticals Inc.
    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 supportQuark Pharmaceuticals Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationQuark Pharmaceuticals Inc.
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street Address7999 Gateway Boulevard, Suite 310
    B.5.3.2Town/ cityNewark
    B.5.3.3Post codeCA 94560
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1510424020
    B.5.6E-maillgryziewicz@quarkpharma.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.3.2Product code QPI-1007 30mg/ml
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravitreal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1231741-17-5
    D.3.9.2Current sponsor codeQPI-1007
    D.3.9.3Other descriptive nameQPI-1007sodium salt.
    D.3.9.4EV Substance CodeSUB179403
    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) 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.3.2Product code QPI-1007 60mg/ml
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravitreal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1231741-17-5
    D.3.9.2Current sponsor codeQPI-1007
    D.3.9.3Other descriptive nameQPI-1007sodium salt.
    D.3.9.4EV Substance CodeSUB179403
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    NAION typically presents as an abrupt, painless monocular vision loss. Visual loss varies widely, ranging from visual field loss only to complete blindness. The neuronal degeneration process in NAION is thought to occur as primary retinal ganglion cell (RGC) axonal and glial damage from ischemia; Damage to RGC axons causes retrograde death of the associated RGC soma by apoptosis, Neuroprotection of partially damaged RGCs would further limit the loss of visual function

    E.1.1.1Medical condition in easily understood language
    Opthic neuropathies represent unmet medical needs.
    Neuroprotection of partially damaged RGCs (retinal ganglion cells ) would further limit the loss of visual function.
    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 LLT
    E.1.2Classification code 10068242
    E.1.2Term Nonarteritic anterior ischaemic optic neuropathy
    E.1.2System Organ Class 100000004853
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To assess the safety and tolerability of QPI-1007 IVT injections in subjects with recent-onset NAION.
    2. To determine the effect on visual function of QPI-1007 IVT injections in subjects with recent-onset NAION.
    E.2.2Secondary objectives of the trial
    To evaluate the structural changes in the peripapillary retinal nerve fiber layer (RNFL) and ganglion cell layer following administration of QPI-1007 in subjects with recent-onset NAION.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Positive diagnosis of first episode of NAION in the study eye, with symptom onset within 14 days prior to Day 1. The NAION diagnosis requires all of the following:
    • Disc edema (observed and documented at the study site)
    • Visual field defects in the study eye consistent with optic neuropathy and mean deviation worse than -3.0 dB on Humphrey standard automated perimetry using theSITA standard 24-2 testing protocol
    • Relative afferent pupillary defect (unless the contralateral eye had previous NAION
    or other optic nerve or retinal disease that is not an exclusion criterion)
    • OCT image and VF pattern compatible with the diagnosis of NAION, as determined by a Central Reading Center.
    2.-Subject is 50 to 80 years of age.
    3.-Best-corrected visual acuity score in the study eye is better than or equal to 15 letter score, measured using the ETDRS visual acuity protocol at Day 1 prior to study drug administration/sham procedure
    4.-Clear ocular media and able to undergo adequate pupil dilation to allow a good fundus examination in the study eye.
    E.4Principal exclusion criteria
    1. Present use or history of any treatment for the current episode of NAION, including systemic steroids or brimonidine. Traditional Chinese herbal medicine taken for the treatment of the current episode of NAION should be discontinued.
    2. Macular disease, proliferative (or pre-proliferative) diabetic retinopathy, or other eye
    disease limiting visual acuity in the study eye only, as determined either by the site
    investigator or at the Reading Center.
    3. Prior episode of NAION in the study eye only.
    4. Bilateral (simultaneous) NAION
    5. NAION secondary to acute blood loss (e.g., due to surgery, trauma, or spontaneous
    hemorrhage) or immediately following any surgery
    6. Prior incisional or laser intraocular surgery in the study eye at any time.
    Note: The following subset of surgeries are allowed within the windows specified for
    each surgery type:
    • Corneal laser surgeries (e.g., laser-assisted in situ keratomileusis) performed more than 1 month prior to Day 1;
    • Laser capsulotomy performed more than 1 week prior to Day 1;
    • Cataract surgery performed more than 3 months prior to Day 1;
    • Glaucoma laser surgery (i.e., laser iridotomy, laser iridoplasty) performed for narrow anterior chamber angle (not for ocular hypertension or glaucoma) performed more than 1 month prior to Day 1;
    • Retinal laser surgeries for small peripheral retinal tears in the study eye performed more than 1 month prior to Day 1.
    7. Any of the following Visual Field exclusions at Screening Visit (inconclusive visual fields should be sent to the Reading Center for adjudication) in the study eye:
    • Less than 3 adjacent abnormal points (>0.5% significance) on the pattern deviation map and the total deviation map
    • Temporal or nasal field loss that respects vertical midline
    • Homonymous binocular field loss (other than bilateral altitudinal in a subject with prior NAION)
    • Heteronymous binocular field loss that is bitemporal
    • Only abnormality on the field is an enlarged blind spot
    8. Pain on eye movement in either eye.
    9. History of vitrectomy in the study eye only
    10. History of vitreous hemorrhage in the study eye only.
    11. History of retinal detachment in the study eye only
    12. History of optic neuritis in either eye.
    13. History of uveitis in either eye.
    14. Any active inflammatory condition in the study eye only (e.g., scleritis, uveitis).
    Note: Mild blepharitis is acceptable.
    15. Any active infectious condition (e.g., conjunctivitis) in either eye.
    16. Glaucoma or ocular hypertension in the study eye only.
    17. Intraocular pressure (IOP) greater than 25 mmHg on Day 1 prior to masked study drug administration in the study eye only.
    18. Present use of drugs known to cause optic nerve or retinal toxicity atDay 1/Randomization, such as: chloroquine or hydroxychloroquine, ethambutol, Vigabatrin. Subjects who need to be prescribed any of these drugs during the course of the study will be discontinued from the trial.
    19. Any other abnormality that, in the opinion of the Investigator, is suggestive of a disease other than NAION in the study eye only.
    Note: Previously established acquired significant dyschromatopsia, non-altitudinal visual field loss in the study eye, large cup-to disc ratio in either eye, greater than 0.6 in the unaffected eye, or Uhthoff phenomenon does not necessarily exclude the subject; however, the Investigator should evaluate these signs and symptoms in the context of whether they are suggestive of a disease other than NAION in the study eye. If they are, then these subjects should be excluded. If the Investigator’s opinion is that they are just coincidental findings, then the subject may be eligible. Inconclusive cases can be discussed with the Medical Monitor.

    E.5 End points
    E.5.1Primary end point(s)
    • The primary endpoint is the proportion of subjects who lose 15 letters or more in best corrected visual acuity (BCVA) score from Baseline (Day 1/Randomization) to Month 6, as measured by ETDRS visual acuity protocol in the study eye.
    The primary endpoint population will include subjects who are randomized within 12 days of the onset of NAION symptoms.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The proportion of subjects losing at least 15 letters in BCVA will be compared among each QPI-1007 treatment group and the control group using the exact multiple logistic regression test. Separate comparisons will be made for the four active treatment groups vs. the sham control group. The analysis will be performed on the mITT population randomized within 12 days of the onset of NAION symptoms.
    E.5.2Secondary end point(s)
    1. The proportion of subjects who lose 15 letters or more in best corrected visual acuity (BCVA) score from Baseline (Day 1) to Month 6, as measured by ETDRS visual acuity protocol in the study eye. This analysis will be conducted in all subjects who are randomized.
    2. Mean change from Day 1 to Month 6 in BCVA letter score, as measured by ETDRS visual acuity protocol in the study eye. This analysis will be conducted in subjects:
    2.1 who are randomized within 12 days of the onset of symptoms
    2.2 who are randomized.
    3. Mean change of visual field mean sensitivity from Day 1 to Month 6, as assessed by Humphrey standard automated perimetry using a full-threshold strategy and a size V
    stimulus in the study eye. This analysis will be conducted in subjects:
    3.1 who are randomized within 12 days of the onset of symptoms.
    3.2 who are randomized.
    E.5.2.1Timepoint(s) of evaluation of this end point
    For the analysis of the key secondary efficacy endpoints, a step-down sequential testing procedure will be used to control the overall type 1 error at 0.05. With this procedure, the primary and two key secondary efficacy endpoints will be evaluated for statistical significance based on a pre-specified sequence for interpretation.
    1. Mean change from Day 1 to Month 12 in BCVA score, as measured by ETDRS visual acuity protocol in
    the study eye.
    2. Mean change of visual field mean sensitivity from Day 1 to Month 12, as assessed by
    Humphrey standard automated perimetry using a full-threshold strategy and a size V
    stimulus in the study eye.
    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) Yes
    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 Yes
    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
    Sham procedure (needleless empty sterile syringe) touched to the surface of the eye to mimic IVT
    E.8.2.4Number of treatment arms in the trial5
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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
    China
    Germany
    India
    Israel
    Italy
    Singapore
    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
    Last visit of the last patient
    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 months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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: 164
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 656
    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 state37
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 65
    F.4.2.2In the whole clinical trial 800
    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)
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Neuro Ophtalmology Research Disease Investigator Consortium NORDIC
    G.4.3.4Network Country United States
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-08-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-06-28
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