Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
Study NCT ID:
NCT00801905
Status:
TERMINATED
Last Update Posted:
2024-05-30
First Post:
2008-12-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Topical Nepafenac in Macular Thickening Related to Pan-retinal Photocoagulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008269', 'term': 'Macular Edema'}], 'ancestors': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C414203', 'term': 'nepafenac'}, {'id': 'D054327', 'term': 'Lubricants'}], 'ancestors': [{'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'whyStopped': 'undefined', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-29', 'studyFirstSubmitDate': '2008-12-03', 'studyFirstSubmitQcDate': '2008-12-03', 'lastUpdatePostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Central macular thickening', 'timeFrame': '2 weeks after each laser session and 1 and 2 months after last laser session'}], 'secondaryOutcomes': [{'measure': 'Best corrected visual acuity', 'timeFrame': '2 weeks after each laser session, 1, 2 and 3 months after pan-retinal photocoagulation is completed'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Macular thickening', 'Macular edema', 'Pan-retinal photocoagulation', 'Nepafenac', 'Topical non-steroidal anti inflammatory agents'], 'conditions': ['Macular Thickening', 'Macular Edema']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether topical nepafenac (qid) is effective in preventing and treating macular thickening related pan-retinal photocoagulation in patients with diabetic retinopathy.', 'detailedDescription': 'Objective: To evaluate the effect of topical nepafenac 0.1 %, in preventing and in treating macular thickening related to pan-retinal photocoagulation in diabetic patients. Material and methods: This is a prospective, longitudinal, and controlled study in patients with diabetic retinopathy (severe non-proliferative and proliferative retinopathy), with a symmetric severity in both eyes and without a clinical significant macular edema. The best corrected visual acuity (BCVA) in all patients was 20/80 or better. All patients will undergo pan-retinal photocoagulation in three different sessions (with 2 weeks in apart between them). Each patient will receive topical nepafenac 0.1% (qid) on one eye, and placebo (qid) at the fellow eye, starting 1 week before the first retinal photocoagulation session and continued for 9 weeks ( ending 4 weeks after pan-retinal photocoagulation is completed). Spectral domain OCT and BCVA in ETDRS scale will be performed before and at 2 weeks after each laser session, and at 1, 2 and 3 months after treatment completed. BCVA and OCT outcomes of each studied period will be compared on both eyes, and side effects will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Severe and proliferative Diabetic Retinopathy\n* Symmetric severity grade on both eyes\n* Best corrected visual acuity better than 20/80\n\nExclusion Criteria:\n\n* Clinical significant macular edema\n* Lens opacity\n* Ocular surgery 6 months or less before recruit\n* Uveitis history\n* Actual use of topical or systemic non-steroidal anti inflammatory agents\n* Actual or history of other macular diseases\n* Ocular surface diseases\n* Vitreomacular traction syndrome\n* Other vascular retinal diseases different to diabetic retinopathy\n* Actual or history of use of topical prostaglandin analogues'}, 'identificationModule': {'nctId': 'NCT00801905', 'acronym': 'NEPAF', 'briefTitle': 'Effect of Topical Nepafenac in Macular Thickening Related to Pan-retinal Photocoagulation', 'organization': {'class': 'OTHER', 'fullName': 'Asociación para Evitar la Ceguera en México'}, 'officialTitle': 'Effect of Topical Nepafenac in Macular Thickening Related to Pan-retinal Photocoagulation', 'orgStudyIdInfo': {'id': 'NEPAFENAC IN PRFC'}, 'secondaryIdInfos': [{'id': 'NEPAFENACO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1: Nepafenac', 'description': 'Topical nepafenac 0.1% is administrated every 6 hour 1 week before start pan-retinal photocoagulation and 4 weeks during all laser session performed biweekly, and 4 weeks after last laser sessión was completed.', 'interventionNames': ['Drug: Nepafenac']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2: placebo', 'description': 'Topical lubricating is administrated every 6 hours at fellow eye 1 week before start pan-retinal photocoagulation, 4 weeks during each laser session performed biweekly, and 4 weeks after last laser sessión was completed', 'interventionNames': ['Other: Lubricant']}], 'interventions': [{'name': 'Nepafenac', 'type': 'DRUG', 'otherNames': ['Nevanac 0.1%'], 'description': 'Topical nepafenac 0.1% is administrated every 6 hour 1 week before start pan-retinal photocoagulation and 4 weeks during all laser session performed biweekly, and 4 weeks after last laser sessión was completed.', 'armGroupLabels': ['1: Nepafenac']}, {'name': 'Lubricant', 'type': 'OTHER', 'otherNames': ['Systane'], 'description': 'Topical lubricating is administrated every 6 hours at fellow eye 1 week before start pan-retinal photocoagulation, 4 weeks during each laser session performed biweekly, and 4 weeks after last laser sessión was completed', 'armGroupLabels': ['2: placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '004030', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Asociación Para Evitar la Ceguera en México I.A.P.', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '04030', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Asociacion para Evitar la Ceguera en Mexico I.A.P.', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'overallOfficials': [{'name': 'Dulce O Rascon-Vargas, Fellow', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asociación Para Evitar la Ceguera en México I.A.P.'}, {'name': 'Guadalupe Cervantes-Coste', 'role': 'STUDY_CHAIR', 'affiliation': 'Asociación Para Evitar la Ceguera en México I.A.P.'}, {'name': 'Jans Fromow-Guerra', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Asociación Para Evitar la Ceguera en México I.A.P.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asociación para Evitar la Ceguera en México', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}