Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-27 @ 2:58 AM
Study NCT ID:
NCT01694095
Status:
COMPLETED
Last Update Posted:
2015-03-24
First Post:
2012-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evolution and Risk Factors Associated With Geographic Atrophy Progression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057092', 'term': 'Geographic Atrophy'}], 'ancestors': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-23', 'studyFirstSubmitDate': '2012-09-22', 'studyFirstSubmitQcDate': '2012-09-22', 'lastUpdatePostDateStruct': {'date': '2015-03-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Median/mean change in best-corrected visual acuity as measured with an Early Treatment Diabetic Retinopathy Study chart', 'timeFrame': 'From baseline to last follow-up'}, {'measure': 'Percentage of eyes developing new choroidal neovascularization in the study eye as evaluated with fluorescein angiography and spectral-domain optical coherence tomography', 'timeFrame': 'From baseline to last follow-up'}, {'measure': 'Median/mean change in area of geographic atrophy as measured in mm2 with fundus autofluorescence on a 30º image centered on field 2', 'timeFrame': 'From baseline to last follow-up', 'description': 'Principal component analysis will be used to reduce the number of independent variables to increase, if possible, the power of the study to detect an association'}], 'primaryOutcomes': [{'measure': 'Median/mean change in area of geographic atrophy as measured in mm2 with fundus autofluorescence on a 30º image centered on field 2', 'timeFrame': 'From baseline to last follow-up', 'description': 'For measures related to change in the area of atrophy, a multivariable model will be fit and will include as an independent variable (amongst other presumed risk factors) fundus autofluorescence patterns'}], 'secondaryOutcomes': [{'measure': 'Median change in area of geographic atrophy as measured in square root of mm2 with fundus autofluorescence on a 30º image centered on field 2', 'timeFrame': 'From baseline to last follow-up', 'description': 'Exploratory analysis, either in the main publication or in another paper'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Geographic atrophy, prognosis, risk factors, natural history'], 'conditions': ['Geographic Atrophy']}, 'referencesModule': {'references': [{'pmid': '22033626', 'type': 'RESULT', 'citation': 'Biarnes M, Mones J, Trindade F, Alonso J, Arias L. Intra and interobserver agreement in the classification of fundus autofluorescence patterns in geographic atrophy secondary to age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol. 2012 Apr;250(4):485-90. doi: 10.1007/s00417-011-1846-y. Epub 2011 Oct 28.'}, {'pmid': '22440276', 'type': 'RESULT', 'citation': 'Mones J, Biarnes M, Trindade F. Hyporeflective wedge-shaped band in geographic atrophy secondary to age-related macular degeneration: an underreported finding. Ophthalmology. 2012 Jul;119(7):1412-9. doi: 10.1016/j.ophtha.2012.01.026. Epub 2012 Mar 21.'}, {'pmid': '23290986', 'type': 'RESULT', 'citation': 'Mones J, Biarnes M, Trindade F, Arias L, Alonso J. Optical coherence tomography assessment of apparent foveal swelling in patients with foveal sparing secondary to geographic atrophy. Ophthalmology. 2013 Apr;120(4):829-36. doi: 10.1016/j.ophtha.2012.09.054. Epub 2013 Jan 3.'}, {'pmid': '25406275', 'type': 'RESULT', 'citation': 'Biarnes M, Forero CG, Arias L, Alonso J, Mones J. Reappraisal of geographic atrophy patterns seen on fundus autofluorescence using a latent class analysis approach. Invest Ophthalmol Vis Sci. 2014 Nov 18;55(12):8302-8. doi: 10.1167/iovs.13-13542.'}]}, 'descriptionModule': {'briefSummary': 'Age-related macular degeneration is one of the leading causes of blindness worldwide. The factors that induce the progression of geographic atrophy, the advanced form of dry age-related macular degeneration, remain poorly understood. The aims of this study are to describe the natural history of geographic atrophy and identify potential risk factors associated with a faster spread of atrophy that may be used to develop rational therapies.', 'detailedDescription': 'Age-related macular degeneration is the leading cause of blindness in developed countries. Geographic atrophy is the advanced form of dry age-related macular degeneration, and currently has no effective therapy. Little is known about the risk factors that drive the progression of geographic atrophy, and yet they are crucial to understand the mechanisms of the disease. Therefore, the identification of risk factors associated with a faster spread of atrophy may help contribute to identify the causes of the disease and, ultimately, to develop new therapeutic strategies to manage the disorder.\n\nThe current prospective, observational, natural history study has the following objectives:\n\n* Describe the natural history of geographic atrophy in anatomic and visual terms\n* Identify risk factors associated with a faster enlargement of atrophy\n\nThe main hypothesis is that lipofuscin accumulation at the borders of atrophy as seen with fundus autofluorescence imaging is associated with a faster progression of the disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with geographic atrophy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both sexes\n* 50 years of age or older\n* Uni or bilateral areas of geographic atrophy in the macula (as defined as areas devoid of retinal pigment epithelium measuring at least 0.5 disk areas on a 35º fundus photograph centered on field 2) secondary to age-related macular degeneration\n* Willing to provide Informed consent\n\nExclusion Criteria:\n\n* Other causes of geographic atrophy aside from age-related macular degeneration (ie, drug induced, central serous chorioretinopathy)\n* Prior history of wet age-related macular degeneration\n* Other significant concomitant macular diseases (ie, significant epiretinal membrane, stage II-IV macular hole)\n* Previous treatment with macular laser photocoagulation, photodynamic therapy, antiangiogenic drugs or other treatments for wet age-related macular degeneration\n* Intraocular surgery aside from phacoemulsification\n* Inability to measure the full extent of the area of atrophy on a 35º fundus autofluorescence image centered on field 2\n* Areas of geographic atrophy in direct contact with peripapillary areas of atrophy'}, 'identificationModule': {'nctId': 'NCT01694095', 'acronym': 'GAIN', 'briefTitle': 'Evolution and Risk Factors Associated With Geographic Atrophy Progression', 'organization': {'class': 'OTHER', 'fullName': 'Institut de la Macula y la Retina'}, 'officialTitle': 'Characterization of Geographic Atrophy Progression in Patients With Age-related Macular Degeneration', 'orgStudyIdInfo': {'id': 'GAIN-002-10-2010'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with geographic atrophy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08017', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Institut de la màcula i de la retina', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Jordi Monés, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut de la màcula i de la retina'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut de la Macula y la Retina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Jordi Mones', 'investigatorAffiliation': 'Institut de la Macula y la Retina'}}}}