Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-30 @ 1:45 PM
Study NCT ID:
NCT01002950
Status:
COMPLETED
Last Update Posted:
2014-03-11
First Post:
2009-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACU-4429 in Subjects With Geographic Atrophy
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'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'dispFirstSubmitDate': '2014-02-07', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-07', 'studyFirstSubmitDate': '2009-10-26', 'dispFirstSubmitQcDate': '2014-02-07', 'studyFirstSubmitQcDate': '2009-10-26', 'dispFirstPostDateStruct': {'date': '2014-03-11', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-03-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety as measured by: AEs, clinical laboratory tests, vital signs, physical exams, visual tests, and questionaire', 'timeFrame': 'Through treatment period (up to Day 90) until 1-2 weeks post last dose (Day 97-104)'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics as measured by plasma ACU-4429 drug levels', 'timeFrame': 'Baseline; Treatment Days 2, 7, 14, 30, 60 and 90'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Dry Age-related Macular Degeneration', '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.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of the investigational drug ACU-4429 in subjects with geographic atrophy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a clinical diagnosis of geographic atrophy, as defined in the protocol\n\nExclusion Criteria:\n\n* Currently receiving or has received a medication prohibited by the protocol'}, 'identificationModule': {'nctId': 'NCT01002950', 'briefTitle': 'Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACU-4429 in Subjects With Geographic Atrophy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kubota Vision Inc.'}, 'officialTitle': 'Multicenter, Randomized, Double-Masked, Placebo-Controlled, Dose Escalation, Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACU-4429 in Subjects With Dry Age-Related Macular Degeneration (Geographic Atrophy)', 'orgStudyIdInfo': {'id': '4429-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ACU-4429 tablet', 'interventionNames': ['Drug: ACU-4429']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Matching placebo tablet', 'interventionNames': ['Drug: Matching placebo']}], 'interventions': [{'name': 'ACU-4429', 'type': 'DRUG', 'description': 'ACU-4429 tablets (2, 5, 7, or 10 mg) taken orally once daily for 90 days', 'armGroupLabels': ['ACU-4429 tablet']}, {'name': 'Matching placebo', 'type': 'DRUG', 'description': 'Matching placebo tablets taken orally once daily for 90 days', 'armGroupLabels': ['Matching placebo tablet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85014', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Retinal Consultants of Arizona', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Retina-Vitreous Associates Medical Group', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '32117', 'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Covance Clinical Research Unit, Inc.', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}, {'zip': '33912', 'city': 'Fort Meyers', 'state': 'Florida', 'country': 'United States', 'facility': 'National Ophthalmic Research Institute'}, {'zip': '96813', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Covance Clinical Research Unit, Inc.', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Kresege Eye Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'Associated Retinal Consultants, P.C. / William Beaumont Hospital', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Eye and Ear Infirmary', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '57701', 'city': 'Rapid City', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Black Hills Regional Eye Institute', 'geoPoint': {'lat': 44.08054, 'lon': -103.23101}}, {'zip': '78752', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Covance Clinical Research Unit', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75247', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Covance Clinical Research Unit, Inc.', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'John W Chandler, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kubota Vision Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kubota Vision Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Otsuka Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}