Ignite Creation Date:
2025-12-24 @ 9:31 PM
Ignite Modification Date:
2025-12-25 @ 7:16 PM
Study NCT ID:
NCT01186432
Status:
COMPLETED
Last Update Posted:
2015-03-05
First Post:
2010-08-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Preliminary Safety and Efficacy of the PDS-1.0 in Patients With Neovascular Age Related Macular Degeneration (AMD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-04', 'studyFirstSubmitDate': '2010-08-19', 'studyFirstSubmitQcDate': '2010-08-20', 'lastUpdatePostDateStruct': {'date': '2015-03-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in retinal thickness measured by Optical Coherence Tomography', 'timeFrame': 'Monthly'}], 'secondaryOutcomes': [{'measure': 'Change in Best Corrected Visual Acuity', 'timeFrame': 'Monthly'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Age-Related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the preliminary safety and efficacy of PDS 1.0 in patients with neovascular AMD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of CNV secondary to AMD confirmed by fluorescein angiography, not previously treated\n* Retinal thickness due to edema of at least 300um in the study eye\n* Best corrected visual acuity of 20/40 or worse in the study eye\n* Best corrected visual acuity of 20/40 or better in the fellow eye\n\nExclusion Criteria:\n\n* Evidence of scarring CNV (e.g. geographic atrophy) in the study eye\n* Fibrosis \\>75% of lesion area in the study eye'}, 'identificationModule': {'nctId': 'NCT01186432', 'briefTitle': 'Preliminary Safety and Efficacy of the PDS-1.0 in Patients With Neovascular Age Related Macular Degeneration (AMD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Forsight Vision4'}, 'orgStudyIdInfo': {'id': 'FSV4 FH-1.2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active', 'description': 'ranibizumab sustained delivery implant', 'interventionNames': ['Drug: PDS 1.0']}], 'interventions': [{'name': 'PDS 1.0', 'type': 'DRUG', 'armGroupLabels': ['Active']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Riga', 'country': 'Latvia', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Forsight Vision4', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}