Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2025-12-27 @ 7:27 AM
Study NCT ID:
NCT04063358
Status:
UNKNOWN
Last Update Posted:
2020-03-26
First Post:
2019-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anti-VEGF Intravitreous Injections for Diabetic Macular Edema in Patients Undergoing Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2021-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-25', 'studyFirstSubmitDate': '2019-08-19', 'studyFirstSubmitQcDate': '2019-08-19', 'lastUpdatePostDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in best-corrected visual acuity (BCVA)', 'timeFrame': '1 month, 3 months , 6 months and 12 months after cataract surgery', 'description': 'BCVA is a measurement of the best vision correction that can be achieved, such as glasses, as measured on the standard Snellen eye chart. For example, if uncorrected eyesight is 20/200, but patient can see 20/20 with glasses, the BCVA is 20/20.'}, {'measure': 'Change in optical coherence tomography (OCT) central subfield (CSF) thickness', 'timeFrame': '24 hours post-operatively, 1 month, 3 months , 6 months and 12 months after cataract surgery', 'description': 'Optical coherence tomography (OCT) is an important imaging modality in the evaluation and management of retinal diseases. Change in central subfield (CSF) thickness will be measured and recorded.'}], 'secondaryOutcomes': [{'measure': 'Total number of postoperative injections', 'timeFrame': '12 months after cataract surgery', 'description': 'Total number of postoperative injections will be calculated'}, {'measure': 'percentage of patients with diabetic retinopathy progression', 'timeFrame': '12 months after cataract surgery', 'description': 'patients with diabetic retinopathy progression will be calculated'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Macular Edema', 'Cataract']}, 'descriptionModule': {'briefSummary': 'The investigators aim to evaluate how different timing of anti-VEGF intravitreous injections affect visual acuity (BCVA) in patients with diabetic macular edema who are undergoing cataract surgery; and to evaluate how different timing of anti-VEGF intravitreous affect OCT CSF thickness and total number of postoperative injections in patients with diabetic macular edema who are undergoing cataract surgery.', 'detailedDescription': 'Cataract is very common in diabetic patients and can lead to significant vision loss and disability without medical intervention. Diabetic patients, particularly those with diabetic macular edema (DME), experience poorer visual outcomes after undergoing cataract surgery compared to non-diabetics. An increased risk in the development of post-operative cystoid macular edema and exacerbation of baseline DME is reported and this poses a significant challenge in managing concomitant DME and visually-significant cataracts.\n\nGoals of the study are to evaluate how different timing of anti-VEGF intravitreous injections (before operation, intra-operation or after-operation) affect visual acuity (BCVA) in patients with persistent diabetic macular edema who are undergoing cataract surgery; and to evaluate how different timing of anti-VEGF intravitreous injections affect OCT CSF thickness and total number of postoperative injections in patients with diabetic macular edema who are undergoing cataract surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdults over age 18 with diabetes mellitus, diabetic macular edema and visually significant cataracts planning to undergo cataract surgery\n\nExclusion Criteria:\n\nPatients who have undergone panretinal photocoagulation (PRP) in prior 4 months or an ocular condition (other than cataract and DME) that might affect visual acuity during course of study.\n\nPatients with history of vitrectomy. Patients with neovascular glaucoma'}, 'identificationModule': {'nctId': 'NCT04063358', 'acronym': 'Anti-VEGF', 'briefTitle': 'Anti-VEGF Intravitreous Injections for Diabetic Macular Edema in Patients Undergoing Cataract Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Second Military Medical University'}, 'officialTitle': 'Timing of Anti-vascular Endothelial Growth Factor（Anti-VEGF） Intravitreous Injections for Diabetic Macular Edema(DME) in Patients Undergoing Cataract Surgery', 'orgStudyIdInfo': {'id': 'SecondMMU2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lucentis injected Pre-operatively', 'description': 'Lucentis injected 2 weeks before cataract surgery', 'interventionNames': ['Drug: Lucentis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lucentis injected intra-operatively', 'description': 'Lucentis injected during the course of the surgery by cataract surgeon.', 'interventionNames': ['Drug: Lucentis']}, {'type': 'EXPERIMENTAL', 'label': 'Lucentis injected post-operatively', 'description': 'Lucentis injected 2 weeks after cataract surgery', 'interventionNames': ['Drug: Lucentis']}], 'interventions': [{'name': 'Lucentis', 'type': 'DRUG', 'description': 'Lucentis 0.5 MG Per 0.05 ML Injection', 'armGroupLabels': ['Lucentis injected Pre-operatively', 'Lucentis injected intra-operatively', 'Lucentis injected post-operatively']}]}, 'contactsLocationsModule': {'locations': [{'zip': '86-21', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'dongyan pan', 'role': 'CONTACT', 'email': 'campus@126.com', 'phone': '86-21-31161995'}], 'facility': 'Changhai Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'dongyan pan', 'role': 'CONTACT', 'email': 'campus@126.com', 'phone': '86-21-31161995'}, {'name': 'wei shen', 'role': 'CONTACT', 'email': 'shenwzz@163.com', 'phone': '86-21-31161995'}], 'overallOfficials': [{'name': 'wei shen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Changhai Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Military Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'pandongyan', 'investigatorAffiliation': 'Second Military Medical University'}}}}