Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-01-07 @ 10:05 AM
Study NCT ID:
NCT01846351
Status:
COMPLETED
Last Update Posted:
2013-05-03
First Post:
2013-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravitreal Anti-VEGF in Exudative AMD With Epiretinal Membranes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019773', 'term': 'Epiretinal Membrane'}, {'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D020256', 'term': 'Choroidal Neovascularization'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-01', 'studyFirstSubmitDate': '2013-05-01', 'studyFirstSubmitQcDate': '2013-05-01', 'lastUpdatePostDateStruct': {'date': '2013-05-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best corrected visual acuity', 'timeFrame': '12 months', 'description': 'Evaluate the best visual acuity during the follow up.'}, {'measure': 'Central macular thickness', 'timeFrame': '12 months', 'description': 'Evaluation of the retinal thickness changes with anti-VEGF treatment'}, {'measure': 'Fluorescein angiogram', 'timeFrame': '12 months', 'description': 'Evaluation of changes in lesion size during follow-up.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['choroidal neovascularization', 'epiretinal membrane', 'anti-VEGF'], 'conditions': ['Epiretinal Membrane', 'Age Related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'Study designed to evaluate the effect of significant ERM on the visual and anatomic outcomes of intravitreal anti-VEGF therapy for eAMD.', 'detailedDescription': 'Gass in 1987 described three cases of epiretinal membrane (ERM) associated with wet macular degeneration. Since then we have seen that is not rare to find the coexistence of these entities. An ERM may produce intrinsic disorganization of the outer retina leading to persistent increased macular thickness and/or edema. This persistent edema may affect the effectiveness in the treatment of exudative age-related macular degeneration (eAMD). Therefore, this study was designed to evaluate the effect of significant ERM on the visual and anatomic outcomes of intravitreal anti-VEGF therapy for eAMD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '58 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'age-related macular degeneration', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Significant epiretinal membrane\n* Anti-VEGF treatment for age-related macular degeneration\n\nExclusion Criteria:\n\n* Uveitis\n* Macular disorders\n* Diabetic retinopathy\n* Vascular occlusions'}, 'identificationModule': {'nctId': 'NCT01846351', 'briefTitle': 'Intravitreal Anti-VEGF in Exudative AMD With Epiretinal Membranes', 'organization': {'class': 'OTHER', 'fullName': 'New England Retina Associates'}, 'officialTitle': 'Visual and Anatomic Outcomes of Intravitreal Anti-VEGF Therapy for Exudative Age-related Macular Degeneration With Concurrent Significant Epiretinal Membrane.', 'orgStudyIdInfo': {'id': 'NAC270608'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Nauman A Chaudhry, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New England Retina Associates'}, {'name': 'Peter E Liggett, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'New England Retina Associates'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New England Retina Associates', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Peter E. Liggett', 'investigatorAffiliation': 'New England Retina Associates'}}}}