Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-03-04 @ 7:50 PM
Study NCT ID:
NCT01253694
Status:
WITHDRAWN
Last Update Posted:
2013-05-03
First Post:
2010-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ranibizumab as a Rescue Therapy for Diabetic Macular Edema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004487', 'term': 'Edema'}], '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': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069579', 'term': 'Ranibizumab'}], 'ancestors': [{'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-05-01', 'studyFirstSubmitDate': '2010-11-30', 'studyFirstSubmitQcDate': '2010-12-02', 'lastUpdatePostDateStruct': {'date': '2013-05-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects with resolution of diabetic macular edema compared to baseline as determined by mean foveal thickness on Spectralis < 300 microns.', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Evaluate the main change in BCVA (best corrected visual acuity) score over time', 'timeFrame': '6-12 months', 'description': 'They will evaluate the amount of patients gaining 3 or more letters and the amount of patients losing 3 or more letters.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diabetes', 'edema', 'ranibizumab', 'bevacizumab', 'refractory'], 'conditions': ['Diabetic Macular Edema']}, 'descriptionModule': {'briefSummary': 'Treatment with Ranibizumab of the residual diabetic edema in patients with failed response to Bevacizumab.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nSubjects will be eligible if the following criteria are met:\n\n1. Age \\> 18 years\n2. Diagnosis of diabetes mellitus (type 1 or 2)\n3. Residual edema as determined by mean foveal thickness on Spectralis OCT (optical coherence tomography) \\> 300 microns and leakage seen on FA at baseline\n4. Clinical evidence of retinal thickening due to macular edema involving the center of the macula, associated with diabetic retinopathy.\n5. Previous history of at least 3-5 or more consecutive 1.25 mg of intravitreal bevacizumab injections for the treatment of diabetic macular edema (consecutive injections administered no more than 6 weeks apart).\n6. BCVA of 20/32-20/400 using Early Treatment Diabetic Retinopathy Study (ETDRS)\n7. Media clarity, pupillary dilation and patient cooperation sufficient to allow OCT testing and retinal photography\n\nExclusion Criteria:\n\n1. Pregnancy (positive pregnancy test) or known to be pregnant; also pre-menopausal women not using adequate contraception.\n2. Participation in another ocular investigation or trial simultaneously.\n3. Systemic use of anti-VEGF within 3 months prior to day 0.\n4. Blood pressure \\> 180/110 (systolic above 180 OR diastolic above 110)\n5. Any condition that, in the opinion of the investigator, would preclude participation in the study (e.g. chronic alcoholism, drug abuse).\n6. Evidence of vitreoretinal interface abnormality after ocular exam or OCT that may be contributing to the macular edema.\n7. An eye that, in the investigator's opinion, has no chance of improving in visual acuity following resolution of macular edema (e.g. presence of subretinal fibrosis, ischemic maculopathy or geographic atrophy).\n8. Presence of another ocular condition that may affect the visual acuity or macular edema during the course of the study (e.g. Age-related Macular Degeneration, uveitis, Irvine-Gass).\n9. Evidence of active neovascularization of the iris or retina.\n10. Evidence of central atrophy or fibrosis in the study eye.\n11. Presence of substantial cataract, one that might decrease the vision by 3 or more lines of vision at sometime during the study.\n12. History of vitreous surgery in the study eye.\n13. History of cataract surgery within 6 months of enrollment.\n14. History of YAG capsulotomy within 2 months of enrollment."}, 'identificationModule': {'nctId': 'NCT01253694', 'briefTitle': 'Ranibizumab as a Rescue Therapy for Diabetic Macular Edema', 'organization': {'class': 'OTHER', 'fullName': 'New England Retina Associates'}, 'officialTitle': 'Ranibizumab in Residual Diabetic Macular Edema Following Previous Intravitreal Bevacizumab Therapy', 'orgStudyIdInfo': {'id': 'DME-NERA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with 3-5 consecutive Avastin injections', 'description': 'These patients will receive 0.5 mg of intravitreal Ranibizumab monthly for 6 months.', 'interventionNames': ['Drug: injection of 0.5 mg of Intravitreal Ranibizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Patients with 6 or more consecutive injections of Bevacizumab', 'description': 'Patients will receive 0.5 mg of intravitreal Ranibizumab during the first 6 months.', 'interventionNames': ['Drug: injection of 0.5 mg of Intravitreal Ranibizumab']}], 'interventions': [{'name': 'injection of 0.5 mg of Intravitreal Ranibizumab', 'type': 'DRUG', 'otherNames': ['Lucentis'], 'description': 'Following the sterile technique, intravitreal injection of anti-VEGF is applied', 'armGroupLabels': ['Patients with 3-5 consecutive Avastin injections', 'Patients with 6 or more consecutive injections of Bevacizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06360', 'city': 'Norwich', 'state': 'Connecticut', 'country': 'United States', 'facility': 'New England Retina Associates', 'geoPoint': {'lat': 41.52426, 'lon': -72.07591}}], 'overallOfficials': [{'name': 'Nauman Chaudhry, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New England Retina Associates'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New England Retina Associates', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}