Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2026-01-24 @ 9:53 PM
Study NCT ID:
NCT02125266
Status:
TERMINATED
Last Update Posted:
2016-12-09
First Post:
2014-04-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Preliminary Efficacy Study of V404 PDS in Uveitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015866', 'term': 'Uveitis, Posterior'}, {'id': 'D015867', 'term': 'Uveitis, Intermediate'}], 'ancestors': [{'id': 'D015864', 'term': 'Panuveitis'}, {'id': 'D014605', 'term': 'Uveitis'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008727', 'term': 'Methotrexate'}], 'ancestors': [{'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'Study terminated due to unacceptable frequency of drug related adverse events', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'dispFirstSubmitDate': '2016-12-07', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-07', 'studyFirstSubmitDate': '2014-04-24', 'dispFirstSubmitQcDate': '2016-12-07', 'studyFirstSubmitQcDate': '2014-04-28', 'dispFirstPostDateStruct': {'date': '2016-12-09', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in macular thickness by ocular coherence tomography', 'timeFrame': 'Baseline, 6 Months'}], 'primaryOutcomes': [{'measure': 'Frequency of adverse events', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Change in vitreous haze score', 'timeFrame': 'Baseline, 6 Months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Uveitis, Posterior', 'Uveitis, Intermediate']}, 'descriptionModule': {'briefSummary': 'This study is intended to evaluate the safety of V404 PDS in patients with chronic non-infectious uveitis. Secondarily, the study will evaluate whether V404 PDS can provide clinically measurable benefit over an extended period of time in patients with chronic non-infectious uveitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Confirmed diagnosis of active uveitis\n* Sufficient lens/media clarity\n* Meet best-corrected visual acuity criteria\n* Willing and able to use contraception\n\nExclusion Criteria:\n\n* Pregnant, breast feeding\n* Uncontrolled glaucoma\n* Intraocular surgery or periocular/intraocular injections within 6 weeks\n* Periocular or intraocular steroid within 3 months\n* Prior vitrectomy\n* Prior corneal transplant\n* Prior fluocinolone implant\n* Allergy or sensitivity to study drug\n* Participation in other trial within 30 days\n* Abnormal liver function\n* History of positive serum tuberculosis test'}, 'identificationModule': {'nctId': 'NCT02125266', 'briefTitle': 'Safety and Preliminary Efficacy Study of V404 PDS in Uveitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Forsight Vision4'}, 'officialTitle': 'A Prospective, Multi-Center, Randomized, Controlled Clinical Trial Designed to Evaluate the Safety and Preliminary Efficacy of V404 PDS in Chronic Noninfectious Uveitis', 'orgStudyIdInfo': {'id': 'V4041'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low Dose V404 PDS', 'description': 'Sustained intravitreal delivery of methotrexate (0.6 mg)', 'interventionNames': ['Drug: V404']}, {'type': 'EXPERIMENTAL', 'label': 'High Dose V404 PDS', 'description': 'Sustained intravitreal delivery of methotrexate (2.3 mg)', 'interventionNames': ['Drug: V404']}], 'interventions': [{'name': 'V404', 'type': 'DRUG', 'otherNames': ['Methotrexate'], 'description': 'Sustained Release', 'armGroupLabels': ['High Dose V404 PDS', 'Low Dose V404 PDS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Golden', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.75554, 'lon': -105.2211}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'city': 'Arlington', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.73569, 'lon': -97.10807}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Forsight Vision4', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}