Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-03-01 @ 4:13 PM
Study NCT ID:
NCT02341560
Status:
TERMINATED
Last Update Posted:
2020-07-20
First Post:
2015-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 2/3, Randomized, Double-Masked, Sham-Controlled Trial of QPI-1007 in Subjects With Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018917', 'term': 'Optic Neuropathy, Ischemic'}], 'ancestors': [{'id': 'D009901', 'term': 'Optic Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C005703', 'term': 'salicylhydroxamic acid'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 732}}, 'statusModule': {'whyStopped': 'An interim analysis did not warrant to continue enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'dispFirstSubmitDate': '2020-07-16', 'completionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-16', 'studyFirstSubmitDate': '2015-01-13', 'dispFirstSubmitQcDate': '2020-07-16', 'studyFirstSubmitQcDate': '2015-01-13', 'dispFirstPostDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of QPI-1007 as assessed by Best Corrected Visual Acuity (BCVA)', 'timeFrame': 'Baseline through Month 12'}, {'measure': 'Safety and tolerability of QPI-1007 as assessed by adverse events (AE), laboratory evaluations, ECGs, ophthalmic evaluations, slit lamp anterior/posterior examinations, intraocular pressure measurements, presence/absence of vitreous inflammation', 'timeFrame': 'Baseline through Month 12'}], 'secondaryOutcomes': [{'measure': 'Mean change in BCVA score, as measured by ETDRS visual acuity protocol in the study eye', 'timeFrame': 'Day 1 through Month 12'}, {'measure': 'Mean change of Visual Fields, as assessed by Humphrey standard automated perimetry', 'timeFrame': 'Day 1 through Month 12'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['NAION'], 'conditions': ['Non Arteritic Anterior Ischemic Optic Neuropathy']}, 'referencesModule': {'references': [{'pmid': '30194931', 'type': 'DERIVED', 'citation': 'Davis JL. The Blunt End: Surgical Challenges of Gene Therapy for Inherited Retinal Diseases. Am J Ophthalmol. 2018 Dec;196:xxv-xxix. doi: 10.1016/j.ajo.2018.08.038. Epub 2018 Sep 5.'}]}, 'descriptionModule': {'briefSummary': 'This study will determine the effect of QPI-1007 on visual function in subjects with recent-onset NAION and assess the safety and tolerability of intravitreal injections of QPI-1007 in this population. This study will also evaluate the structural changes in the retina following administration of QPI-1007.', 'detailedDescription': 'This is a double masked, randomized, sham-controlled efficacy and safety study that will enroll approximately 800 subjects with recent-onset NAION. Subjects will be randomized into one of 3 groups in a 1:1:1 ratio, and assigned to receive QPI-1007 and/or a sham procedure. Subjects will have a two in three (66%) chance of receiving active treatment (no sham procedure) and a one in three (33%) chance of receiving sham procedure (no active treatment). Total study time involvement is approximately 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Positive diagnosis of first episode of NAION in the study eye with symptom onset within 14 days prior to planned study drug administration/sham procedure\n* 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.\n* Clear ocular media and able to undergo adequate pupil dilation to allow a good fundus examination\n\nKey Exclusion Criteria:\n\n* Present use or history of any treatment for the current episode of NAION, including systemic steroids, brimonidine, or traditional Chinese herbal medicine\n* Prior episode of NAION in the study eye only\n* Present use of drugs known to cause optic nerve or retinal toxicity at Day 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.\n* Any medical condition, concomitant therapy, or previous incisional or laser surgery that, in the opinion of the Investigator, would preclude IVT injection in the study eye only\n* Clinical evidence of temporal arteritis'}, 'identificationModule': {'nctId': 'NCT02341560', 'briefTitle': 'Phase 2/3, Randomized, Double-Masked, Sham-Controlled Trial of QPI-1007 in Subjects With Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Quark Pharmaceuticals'}, 'officialTitle': 'A Phase 2/3, Randomized, Double-Masked, Sham-Controlled Trial of QPI-1007 Delivered By Single or Multi-Dose Intravitreal Injection(s) to Subjects With Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)', 'orgStudyIdInfo': {'id': 'QRK207'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'single dose or multiple dose', 'description': 'QPI-1007 Injection - 1.5 mg', 'interventionNames': ['Drug: QPI-1007 Injection - 1.5 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'single or multiple dose', 'description': 'QPI-1007 Injection - 3.0 mg', 'interventionNames': ['Drug: QPI-1007 Injection - 3.0 mg']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham', 'description': 'Sham injection procedure', 'interventionNames': ['Other: Sham Injection Procedure']}], 'interventions': [{'name': 'QPI-1007 Injection - 1.5 mg', 'type': 'DRUG', 'otherNames': ['QPI-1007'], 'armGroupLabels': ['single dose or multiple dose']}, {'name': 'QPI-1007 Injection - 3.0 mg', 'type': 'DRUG', 'otherNames': ['QPI-1007'], 'armGroupLabels': ['single or multiple dose']}, {'name': 'Sham Injection Procedure', 'type': 'OTHER', 'otherNames': ['Sham'], 'description': 'Sham Procedure', 'armGroupLabels': ['Sham']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 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