Ignite Creation Date:
2025-12-24 @ 1:02 PM
Ignite Modification Date:
2025-12-27 @ 10:03 PM
Study NCT ID:
NCT00926861
Status:
UNKNOWN
Last Update Posted:
2010-06-09
First Post:
2009-06-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Posterior Macular Adhesion: A Potential Risk Factor for Non-exudative Age Related Macular Degeneration (AMD) to Develop Exudative AMD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 320}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-06-08', 'studyFirstSubmitDate': '2009-06-23', 'studyFirstSubmitQcDate': '2009-06-23', 'lastUpdatePostDateStruct': {'date': '2010-06-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of eyes with non-exudative AMD with attached and detached posterior vitreous cortex developing exudative AMD', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'Distance acuity', 'timeFrame': '24 months'}, {'measure': 'Age', 'timeFrame': '24 months'}, {'measure': 'Smoking', 'timeFrame': '24 months'}, {'measure': 'Obesity', 'timeFrame': '24 months'}, {'measure': 'Lesion classification (AREDS)', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['age-related macular degeneration', 'detachment of the posterior hyaloid', 'AMD'], 'conditions': ['Dry Age-related Macular Degeneration', 'Detachment of the Posterior Hyaloid']}, 'descriptionModule': {'briefSummary': 'Choroidal neovascularisation in age related macular degeneration is one of the major causes of legal blindness in the western world existing in two major occurences, the dry and the wet form.The etiology of age related macular degeneration is yet unknown. Genetic factors, oxidative stress, Ischaemia, and aging of the retinal pigment epithelium are discussed as etiologic factors. The risk of rapid vision loss is much higher in wet AMD, a dry form may transform to a wet form. From a prior study the investigators know that the posterior hyaloid is significantly more frequent attached in wet AMD. This study is conducted to examine whether the attached posterior hyaloid is a risk factor to develop wet AMD in dry AMD cases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'male or female persons aged over 50 years with dry AMD', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Dry MD\n* Age over 50 years\n\nExclusion Criteria:\n\n* Macular pathologies other than age related macular degeneration (like diabetic maculopathy, macular pucker, macular hole)\n* Prior vitrectomy or buckle surgery\n* Uveitis posterior, multifocal chorioiditis\n* Pathologic myopia\n* Diabetic retinopathy\n* Visualization of the macula not possible (dens cataract, vitreous haemorrhage)'}, 'identificationModule': {'nctId': 'NCT00926861', 'acronym': 'PAM', 'briefTitle': 'Posterior Macular Adhesion: A Potential Risk Factor for Non-exudative Age Related Macular Degeneration (AMD) to Develop Exudative AMD', 'organization': {'class': 'OTHER', 'fullName': 'The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery'}, 'officialTitle': 'Posterior Macular Adhesion: A Potential Risk Factor for Non-exudative AMD to Develop Exudative AMD', 'orgStudyIdInfo': {'id': '09-052-0409'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Dry AMD', 'description': 'male or female persons aged over 50 years with dry age-related macular degeneration', 'interventionNames': ['Device: ultrasound', 'Device: OCT']}], 'interventions': [{'name': 'ultrasound', 'type': 'DEVICE', 'description': 'A-scan and B-scan ultrasound at baseline and month 6,12,24', 'armGroupLabels': ['Dry AMD']}, {'name': 'OCT', 'type': 'DEVICE', 'description': 'Volume scans of spectralis OCT at baseline and month 6,12,24', 'armGroupLabels': ['Dry AMD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1030', 'city': 'Vienna', 'state': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Ilse Krebs, MD', 'role': 'CONTACT', 'email': 'Ilse.Krebs@wienkav.at', 'phone': '43-17-1165', 'phoneExt': '94682'}, {'name': 'Ilse Krebs, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Ilse Krebs, MD', 'role': 'CONTACT', 'email': 'ilse.krebs@wienkav.at', 'phone': '+43171165', 'phoneExt': '4607'}], 'overallOfficials': [{'name': 'Susanne Binder, Prof MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Ilse Krebs,MD', 'oldOrganization': 'The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery'}}}}