Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2026-02-26 @ 6:53 AM
Study NCT ID:
NCT00491166
Status:
UNKNOWN
Last Update Posted:
2007-06-25
First Post:
2007-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of Bromfenac Ophthalmic Solution in Subjects With Diffuse Diabetic Macular Edema (DME) Refractory to Laser
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-06', 'lastUpdateSubmitDate': '2007-06-22', 'studyFirstSubmitDate': '2007-06-21', 'studyFirstSubmitQcDate': '2007-06-22', 'lastUpdatePostDateStruct': {'date': '2007-06-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The mean change in visual acuity and central retinal thickness from baseline to month 3,and the incidence and severity of ocular adverse events and other adverse events.', 'timeFrame': 'Baseline to month 3'}], 'secondaryOutcomes': [{'measure': 'Changes in retinal leakage as determined by fluorescein angiography', 'timeFrame': 'Baseline to month 3'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diabetic macular edema', 'bromfenac ophthalmic solution'], 'conditions': ['Diabetic Macular Edema']}, 'descriptionModule': {'briefSummary': 'This is an investigator-sponsored trial (IST), an open-label pilot study, assessing the safety and biologic activity of bromfenac in subjects with diffuse DME refractory to laser.', 'detailedDescription': 'Ten subjects will be enrolled in this study, which will be conducted at Ophthalmic Consultants of Boston, Boston, MA. All subjects must be diagnosed with diffuse DME that is either refractory to laser photocoagulation or in patients who have refused laser.\n\nConsented subjects will be screened to determine eligibility. Eligibility will be determined by the Investigator, a retinal specialist. Only one eye will be chosen as the "study eye." Only the study eye will receive bromfenac drops during the study.\n\nEligible subjects will self-administer bromfenac two times per day (BID) for three months (treatment period). Subjects will have monthly examinations during the treatment period, followed by follow up visits at Month 4 and Month 6.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Center-involved macular edema secondary to diabetes mellitus\n\nExclusion Criteria:\n\n* Study eye with edema amenable to focal laser\n* Treatment with laser, intraocular steroids, and anti-VEGF agents within 90 days\n* Current eye infections'}, 'identificationModule': {'nctId': 'NCT00491166', 'briefTitle': 'Safety Study of Bromfenac Ophthalmic Solution in Subjects With Diffuse Diabetic Macular Edema (DME) Refractory to Laser', 'organization': {'class': 'OTHER', 'fullName': 'Ophthalmic Consultants of Boston'}, 'officialTitle': 'A Single-Center, Investigator-Sponsored Pilot Study to Assess Safety and Biologic Activity of Bromfenac Ophthalmic Solution, 0.09%, in Subjects With Diffuse DME Refractory to Laser', 'orgStudyIdInfo': {'id': 'X-DME-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Bromfenac ophthalmic solution', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jeffrey S Heier, MD', 'role': 'CONTACT', 'phone': '617-314-2611'}, {'name': 'Sandy G Chong', 'role': 'CONTACT', 'email': 'schong@eyeboston.com', 'phone': '617-314-2627'}, {'name': 'Jeffrey S Heier, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ophthalmic Consultants of Boston', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Jeffrey S Heier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ophthalmic Consultants of Boston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ophthalmic Consultants of Boston', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bausch & Lomb Incorporated', 'class': 'INDUSTRY'}]}}}