Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2026-01-22 @ 11:11 AM
Study NCT ID:
NCT02060604
Status:
COMPLETED
Last Update Posted:
2014-02-12
First Post:
2014-02-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study of Ranibizumab With and Without Ketorolac Eyedrops for Exudative Age-related Macular Degeneration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057135', 'term': 'Wet Macular Degeneration'}, {'id': 'D020256', 'term': 'Choroidal Neovascularization'}], 'ancestors': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D015862', 'term': 'Choroid Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D009389', 'term': 'Neovascularization, Pathologic'}, {'id': 'D008679', 'term': 'Metaplasia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020910', 'term': 'Ketorolac'}, {'id': 'D000069579', 'term': 'Ranibizumab'}], 'ancestors': [{'id': 'D007213', 'term': 'Indomethacin'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-08', 'studyFirstSubmitDate': '2014-02-08', 'studyFirstSubmitQcDate': '2014-02-08', 'lastUpdatePostDateStruct': {'date': '2014-02-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mean change in study eye visual acuity as measured by the best-corrected ETDRS letter score', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'mean change in central macular thickness', 'timeFrame': '12 months'}, {'measure': 'mean number of intravitreal injections over the 12-month period', 'timeFrame': '12 months'}, {'measure': 'adverse ocular events at 12 months', 'timeFrame': '12 months'}]}, 'conditionsModule': {'keywords': ['ketorolac', 'NSAIDs', 'wet macular degeneration', 'choroidal neovascularization'], 'conditions': ['Wet Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'The addition of an anti-inflammatory agent could be a valid option for controlling choroidal neovascularization, as simply inhibiting VEGF addresses neither the multifactorial pathogenesis of choroidal neovascularization nor the underlying cause of VEGF production.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ability to provide written informed consent and comply with study assessments for the full duration of the study;\n2. age \\>40 years;\n3. presence of treatment-naïve neovascular AMD with a visual acuity between 20/25 and 20/200 on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. Inclusion criteria for AMD were neovascularisation, fluid, or haemorrhage under the fovea.\n\nExclusion Criteria:\n\n1. any previous intravitreal treatment;\n2. previous laser treatment in the study eye;\n3. myopia \\>7 dioptres in the study eye;\n4. concurrent eye disease in the study eye that could compromise visual acuity (eg, diabetic retinopathy, advanced glaucoma);\n5. concurrent corneal epithelial disruption or any condition that would affect the ability of the cornea to heal;\n6. known sensitivity to any component of the formulations under investigation.'}, 'identificationModule': {'nctId': 'NCT02060604', 'briefTitle': 'Pilot Study of Ranibizumab With and Without Ketorolac Eyedrops for Exudative Age-related Macular Degeneration', 'organization': {'class': 'OTHER', 'fullName': 'Università degli Studi di Brescia'}, 'officialTitle': 'A Randomised Controlled Trial of Ranibizumab With and Without Ketorolac Eyedrops for Exudative Age-related Macular Degeneration', 'orgStudyIdInfo': {'id': 'NSAIDs_01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketorolac + Ranibizumab', 'description': '3 monthly ranibizumab, then as needed plus ketorolac eyedrops TID', 'interventionNames': ['Drug: Ketorolac + Ranibizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ranibizumab Alone', 'description': '3 monthly ranibizumab, then as needed', 'interventionNames': ['Drug: Ranibizumab']}], 'interventions': [{'name': 'Ketorolac + Ranibizumab', 'type': 'DRUG', 'description': '3 monthly ranibizumab, then as needed Ketorolac TID', 'armGroupLabels': ['Ketorolac + Ranibizumab']}, {'name': 'Ranibizumab', 'type': 'DRUG', 'description': '3 monthly ranibizumab, then as needed', 'armGroupLabels': ['Ranibizumab Alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25123', 'city': 'Brescia', 'state': 'BS', 'country': 'Italy', 'facility': 'Spedali Civili di Brescia', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}], 'overallOfficials': [{'name': 'Andrea Russo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Brescia, Italy'}, {'name': 'Luisa Delcassi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Brescia, Italy'}, {'name': 'Francesco Semeraro, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Brescia, Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Università degli Studi di Brescia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Andrea Russo', 'investigatorAffiliation': 'Università degli Studi di Brescia'}}}}