Ignite Creation Date:
2025-12-26 @ 2:42 PM
Ignite Modification Date:
2026-02-21 @ 1:06 PM
Study NCT ID:
NCT00665106
Status:
COMPLETED
Last Update Posted:
2015-05-27
First Post:
2008-04-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerability of NOVA63035 "Corticosteroid" in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003930', 'term': 'Diabetic Retinopathy'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-26', 'studyFirstSubmitDate': '2008-04-22', 'studyFirstSubmitQcDate': '2008-04-22', 'lastUpdatePostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ocular safety', 'timeFrame': 'Over one year'}]}, 'conditionsModule': {'keywords': ['Diabetic macular edema', 'Diabetes', 'Diabetic retinopathy'], 'conditions': ['Diabetic Macular Edema']}, 'descriptionModule': {'briefSummary': 'Evaluation of safety and tolerability of a single injection of NOVA63035 "Corticosteroid" administered at one of four doses in patients with diabetic macular edema (DME) secondary to diabetic retinopathy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* M \\& F 18 years and older\n* Diagnosed with diabetes mellitus and presenting diabetic retinopathy\n\nExclusion Criteria:\n\n* Monocular\n* History of current ocular hypertension or glaucoma in either eye defined\n* Any significant ocular disease (other than diabetic retinopathy)'}, 'identificationModule': {'nctId': 'NCT00665106', 'briefTitle': 'Safety and Tolerability of NOVA63035 "Corticosteroid" in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Santen SAS'}, 'officialTitle': 'A Phase I, Open-Label, Dose-Escalation Clinical Study to Assess the Safety and Tolerability of NOVA63035 in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy', 'orgStudyIdInfo': {'id': 'NVG07D108'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cohort 1', 'description': '5 up to 6 patients per arm. Emulsion at 0.8% of drug product.', 'interventionNames': ['Drug: NOVA63035 "Corticosteroid"']}, {'type': 'EXPERIMENTAL', 'label': 'cohort 2', 'description': '5 up to 6 patients per arm. Emulsion at 0.8% of drug product.', 'interventionNames': ['Drug: NOVA63035 "Corticosteroid"']}, {'type': 'EXPERIMENTAL', 'label': 'cohort 3', 'description': '5 up to 6 patients per arm. Emulsion at 3.2% of drug product.', 'interventionNames': ['Drug: NOVA63035 "Corticosteroid"']}, {'type': 'EXPERIMENTAL', 'label': 'cohort 4', 'description': '5 up to 6 patients per arm. Oily solution at 3.4% of drug product.', 'interventionNames': ['Drug: NOVA63035 "Corticosteroid"']}], 'interventions': [{'name': 'NOVA63035 "Corticosteroid"', 'type': 'DRUG', 'description': 'Single injection in the study eye', 'armGroupLabels': ['cohort 1', 'cohort 2', 'cohort 3', 'cohort 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46280', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Midwest Eye Institute', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Santen SAS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}