Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-01-05 @ 6:21 PM
Study NCT ID:
NCT02228304
Status:
TERMINATED
Last Update Posted:
2022-07-18
First Post:
2014-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Intravitreal Implantation of NT-503-3 Encapsulated Cell Technology (ECT) for the Treatment of Recurrent Choroidal Neovascularization (CNV) Secondary to 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', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'whyStopped': 'After enrolling approximately 1/2 of the trial participants, the rescues exceeded stopping criteria.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'dispFirstSubmitDate': '2016-11-15', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-14', 'studyFirstSubmitDate': '2014-08-27', 'dispFirstSubmitQcDate': '2016-11-15', 'studyFirstSubmitQcDate': '2014-08-28', 'dispFirstPostDateStruct': {'date': '2016-11-16', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients with less than a 3-line loss of BCVA in ETDRS letters', 'timeFrame': 'Week 52 and Week 108'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in best corrected visual acuity (BCVA)', 'timeFrame': 'Week 52'}, {'measure': 'Change from baseline in macular thickness as determined by Spectral Domain Optical Coherence Tomography (sdOCT)', 'timeFrame': 'Up to Week 108'}, {'measure': 'Mean (median) number of Eylea® injections and number of patients requiring Eylea® injections for rescue therapy', 'timeFrame': 'Up to Week 108'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Wet AMD', 'Wet Age Related Macular Degeneration', 'Recurrent CNV Secondary to AMD', 'Active subfoveal CNV'], 'conditions': ['Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'Prospective, multi-center 2-stage study. Stage 1 (Phase I) is open-label with all patients treated with the NT-503-3 ECT implant. Stage 1 (Phase I) patients will undergo explantation at year 2. Those who, in the opinion of the investigator, are still candidates for continued anti-VEGF therapy will be re-implanted with a new NT-503-3 investigational product and followed for an additional 12 weeks before study exit. Stage 2 (Phase II) is a separate, randomized, masked phase during which eligible patients will be randomized to the NT-503-3 group or the control group.\n\nClinical Hypotheses:\n\n* NT-503-3 ECT is comparable to Eylea® injected intravitreally every 8 weeks in the prevention of vision loss due to recurrent CNV secondary to AMD\n* NT-503-3 ECT has an acceptable safety profile'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Diagnosis of Active (recurrent or persistent) subfoveal CNV lesions secondary to AMD in the study eye\n* Prior Intravitreal Anti-VEGF injections\n\nKey Exclusion Criteria:\n\n* Significant subretinal hemorrhage\n* Significant Scar and/or, fibrosis\n* Suspected polypoidal choroidopathy, or pigment epithelial tears or rips\n* Inadequate response to anti-VEGF therapy'}, 'identificationModule': {'nctId': 'NCT02228304', 'briefTitle': 'Study of the Intravitreal Implantation of NT-503-3 Encapsulated Cell Technology (ECT) for the Treatment of Recurrent Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Neurotech Pharmaceuticals'}, 'officialTitle': 'A Multi-Center, Two-Stage, Open-Label Phase I and Randomized, Active Controlled, Masked Phase II Study to Evaluate the Safety and Efficacy of Intravitreal Implantation of NT-503-3 Encapsulated Cell Technology Compared With Eylea for the Treatment of Recurrent CNV Secondary to AMD', 'orgStudyIdInfo': {'id': 'NT-503-3-AMD-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NT-503-3 ECT implantation', 'interventionNames': ['Drug: NT-503-3 ECT implantation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Eylea® injected intravitreally every 8 weeks', 'description': 'Eylea® injected intravitreally every 8 weeks', 'interventionNames': ['Drug: Eylea® injected intravitreally administered every 8 weeks']}], 'interventions': [{'name': 'NT-503-3 ECT implantation', 'type': 'DRUG', 'description': 'NT-503-3 ECT implantation is a biological sustained drug delivery device that could provide continuous delivery of an anti-VEGF therapy', 'armGroupLabels': ['NT-503-3 ECT implantation']}, {'name': 'Eylea® injected intravitreally administered every 8 weeks', 'type': 'DRUG', 'description': 'The first part, stage 1, Phase I is open label with the experimental treatment arm only. Eylea® injected intravitreally is only used as a comparator in the stage 2, Phase II, portion of the study.', 'armGroupLabels': ['Eylea® injected intravitreally every 8 weeks']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85020', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Associated Retina Consultants, Ltd.', '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': '92697', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Irvine, The Gavin Herbert Eye Institute', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Jacobs Retina Center at UCSD', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '80401', 'city': 'Golden', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Retina Associates', 'geoPoint': {'lat': 39.75554, 'lon': -105.2211}}, {'zip': '33907', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Retina Health Center', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33912', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'National Ophthalmic Research Institute', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33880', 'city': 'Winter Haven', 'state': 'Florida', 'country': 'United States', 'facility': 'Center for Retina and Macular Disease', 'geoPoint': {'lat': 28.02224, 'lon': -81.73286}}, {'zip': '30909', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Southeast Retina Center, PC', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgina Retina, P.C.', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '60435', 'city': 'Joliet', 'state': 'Illinois', 'country': 'United States', 'facility': 'Illinois Retina Associates, S.C.', 'geoPoint': {'lat': 41.52519, 'lon': -88.0834}}, {'zip': '60304', 'city': 'Oak Park', 'state': 'Illinois', 'country': 'United States', 'facility': 'Illinois Retina Associates', 'geoPoint': {'lat': 41.88503, 'lon': -87.7845}}, {'zip': '40509', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Retina Associates of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '20815', 'city': 'Chevy Chase', 'state': 'Maryland', 'country': 'United States', 'facility': 'The Retina Group of Washington', 'geoPoint': {'lat': 39.00287, 'lon': -77.07115}}, {'zip': '21740', 'city': 'Hagerstown', 'state': 'Maryland', 'country': 'United States', 'facility': 'Cumberland Valley Retina Consultants, PC', 'geoPoint': {'lat': 39.64176, 'lon': -77.71999}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Ophthalmic Consultants of Boston', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48105', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan, Kellogg Eye Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospital-Ophthalmology Research', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '63017', 'city': 'Chesterfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Lifelong Vision Foundation', 'geoPoint': {'lat': 38.66311, 'lon': -90.57707}}, {'zip': '89502', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'facility': 'Sierra Eye Associates', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'zip': '07003', 'city': 'Bloomfield', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Retina Center of New Jersey, LLC', 'geoPoint': {'lat': 40.80677, 'lon': -74.18542}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'NJ Retina', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '28803', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Western Carolina Retinal Associates', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Baptist Health Eye Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Retina Northwest, PC', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Mid Atlantic Retina', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29501', 'city': 'Florence', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Palmetto Retina Center, LLC', 'geoPoint': {'lat': 34.19543, 'lon': -79.76256}}, {'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': '78503', 'city': 'McAllen', 'state': 'Texas', 'country': 'United States', 'facility': 'Valley Retina Institute, PA', 'geoPoint': {'lat': 26.20341, 'lon': -98.23001}}, {'zip': '78240', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Medical Center Ophthalmology Associates', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'city': 'Beersheba', 'country': 'Israel', 'facility': 'Soroka Medical Center', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'zip': '91120', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah-Hebrew University Medical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '44281', 'city': 'Kfar Saba', 'country': 'Israel', 'facility': 'Meir Medical Center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}, {'zip': '49100', 'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'Rabin Medical Center', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'zip': '76100', 'city': 'Rehovot', 'country': 'Israel', 'facility': 'Kaplan Medical Center', 'geoPoint': {'lat': 31.89421, 'lon': 34.81199}}, {'zip': '64239', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Sourasky Medical Center,', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'overallOfficials': [{'name': 'Charles Johnson, MB, ChB', 'role': 'STUDY_CHAIR', 'affiliation': 'Neurotech Pharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neurotech Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}