Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-29 @ 2:14 AM
Study NCT ID:
NCT01802866
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2013-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Assessment Treatment Trials of Emixustat Hydrochloride
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057092', 'term': 'Geographic Atrophy'}], 'ancestors': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000592692', 'term': 'emixustat'}]}}, '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': 508}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'dispFirstSubmitDate': '2017-06-26', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-26', 'studyFirstSubmitDate': '2013-02-28', 'dispFirstSubmitQcDate': '2017-06-26', 'studyFirstSubmitQcDate': '2013-02-28', 'dispFirstPostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in the total area of the GA lesion(s)', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in BCVA score', 'timeFrame': '24 months'}, {'measure': 'Frequency of AEs, discontinuations due to AEs, or dose modifications; severity and seriousness of AEs', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Geographic atrophy', 'GA', 'Dry AMD'], 'conditions': ['Geographic Atrophy']}, 'referencesModule': {'references': [{'pmid': '33331670', 'type': 'DERIVED', 'citation': 'Yeong JL, Loveman E, Colquitt JL, Royle P, Waugh N, Lois N. Visual cycle modulators versus placebo or observation for the prevention and treatment of geographic atrophy due to age-related macular degeneration. Cochrane Database Syst Rev. 2020 Dec 17;12(12):CD013154. doi: 10.1002/14651858.CD013154.pub2.'}, {'pmid': '29716784', 'type': 'DERIVED', 'citation': 'Rosenfeld PJ, Dugel PU, Holz FG, Heier JS, Pearlman JA, Novack RL, Csaky KG, Koester JM, Gregory JK, Kubota R. Emixustat Hydrochloride for Geographic Atrophy Secondary to Age-Related Macular Degeneration: A Randomized Clinical Trial. Ophthalmology. 2018 Oct;125(10):1556-1567. doi: 10.1016/j.ophtha.2018.03.059. Epub 2018 Apr 30.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if emixustat hydrochloride (ACU-4429) reduces the rate of progression of geographic atrophy compared to placebo in subjects with dry age-related macular degeneration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males or females, age ≥55 years.\n2. Clinical diagnosis of GA associated with AMD\n3. Able and willing to provide written informed consent.\n4. Able to reliably administer oral medication by self or with available assistance.\n\nExclusion Criteria:\n\n1. Active CNV or presence of an active ocular disease.\n2. Known serious allergy to the fluorescein sodium for injection in angiography.\n3. Pre-specified laboratory abnormalities at screening.\n4. Treatment with any investigational study drug within 30 days of screening or device (within 60 days of screening)\n5. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding\n6. Female subjects who are pregnant or lactating.\n7. Female subjects of childbearing potential and male subjects who are not surgically sterile who are not willing to practice a medically accepted method of birth control from screening through 30 days after completion of the study.\n8. Unstable or poorly controlled medical or ophthalmic conditions'}, 'identificationModule': {'nctId': 'NCT01802866', 'acronym': 'SEATTLE', 'briefTitle': 'Safety and Efficacy Assessment Treatment Trials of Emixustat Hydrochloride', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kubota Vision Inc.'}, 'officialTitle': 'A Phase 2b/3 Multicenter, Randomized, Double-Masked, Dose-Ranging Study Comparing the Efficacy and Safety of Emixustat Hydrochloride (ACU-4429) With Placebo for the Treatment of Geographic Atrophy Associated With Dry Age-Related Macular Degeneration', 'orgStudyIdInfo': {'id': '4429-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ACU-4429 2.5 mg', 'description': '2.5 mg tablet', 'interventionNames': ['Drug: ACU-4429']}, {'type': 'EXPERIMENTAL', 'label': 'ACU-4429 5 mg', 'description': '5 mg tablet', 'interventionNames': ['Drug: ACU-4429']}, {'type': 'EXPERIMENTAL', 'label': 'ACU-4429 10 mg', 'description': '10 mg tablet', 'interventionNames': ['Drug: ACU-4429']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Includes identical tablets with only inactive ingredients (0 mg).', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ACU-4429', 'type': 'DRUG', 'otherNames': ['emixustat hydrochloride'], 'description': 'Take orally once daily for 24 months', 'armGroupLabels': ['ACU-4429 10 mg', 'ACU-4429 2.5 mg', 'ACU-4429 5 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Take orally once daily for 24 months', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}], 'overallOfficials': [{'name': 'Acucela Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kubota Vision Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kubota Vision Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Otsuka Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}