Viewing Study NCT01103505


Ignite Creation Date: 2025-12-25 @ 3:30 AM
Ignite Modification Date: 2025-12-26 @ 2:12 AM
Study NCT ID: NCT01103505
Status: COMPLETED
Last Update Posted: 2019-07-30
First Post: 2010-04-12
Is NOT Gene Therapy: False
Has Adverse Events: True

Brief Title: HOme Vision Monitoring in AREDS2 for Progression to Neovascular AMD Using the ForeseeHome Device
Sponsor:
Organization:

Raw JSON

{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Grace.Chang@NotalVision.com', 'phone': '571-719-6416', 'title': 'Grace Chang, MD, PhD', 'organization': 'Notal Vision'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Device Monitoring Arm', 'description': 'Participants in the ForeseeHome AMD device monitoring arm will receive a device for at home use, with instructions to install and connect the device to a modem as well as instructions for daily use of the device, in addition to standard care.', 'otherNumAtRisk': 763, 'deathsNumAtRisk': 763, 'otherNumAffected': 0, 'seriousNumAtRisk': 763, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Care (Control) Arm', 'description': 'Standard care arm study participants will receive instruction per clinic routine for home vision monitoring (e.g. Amsler grid) to detect progression of AMD in addition to routine scheduled eye exams', 'otherNumAtRisk': 757, 'deathsNumAtRisk': 757, 'otherNumAffected': 0, 'seriousNumAtRisk': 757, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Primary Outcome: Change in Visual Acuity (LogMAR Letters) From Baseline to Detection of Choroidal Neovascularization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ForeseeHome + Standard Care at CNV Progression', 'description': 'Patients who progressed from intermediate AMD to CNV and who were randomized to ForeseeHome use + Standard Care at the time CNV developed'}, {'id': 'OG001', 'title': 'Standard Care Alone (Control) at CNV Progression', 'description': 'Patients who progressed from intermediate AMD to CNV and were randomized to Standard Care alone (control arm) at the time CNV developed.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.4', 'spread': '11.4', 'groupId': 'OG000'}, {'value': '-12.6', 'spread': '16.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': 'Mean change in BCVA (logMAR letters) from baseline to the time of confirmed progression to CNV in the ForeseeHome device monitoring group compared to the standard care group.', 'unitOfMeasure': 'LogMAR letters (ETDRS)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients in each study arm that progressed from intermediate AMD to CNV during the study were evaluated according to the primary and secondary endpoints. 51 of 763 patients in the device + standard care arm progressed to CNV during the trial, and 30 of 757 patients in the standard care alone arm progressed to CNV during the trial.'}, {'type': 'SECONDARY', 'title': 'Secondary Outcome: Patients Who Maintained 20/40 or Better Vision at Time of CNV Detection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Device Monitoring Arm', 'description': 'Participants in the ForeseeHome use + Standard Care monitoring arm who maintained 20/40 or better vision at time of CNV detection'}, {'id': 'OG001', 'title': 'Standard Care (Control) Arm', 'description': 'Participants in the Standard Care alone monitoring arm who maintained 20/40 or better vision at time of CNV detection'}], 'classes': [{'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Percent of patients who maintained 20/40 or better vision at the time of CNV detection in each study arm', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': '51 of 763 patients progressed to CNV in the device arm and 30 of 757 patients progressed to CNV in the standard care alone arm. Patients that progressed to CNV were analyzed in this secondary analysis.'}, {'type': 'SECONDARY', 'title': 'Secondary Outcome: Lesion Size (Total Lesion Area) at Time of Confirmed Progression to CNV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Device Monitoring Arm', 'description': 'Lesion size (total lesion area) of participants in the ForeseeHome use + Standard Care monitoring arm at time of CNV detection'}, {'id': 'OG001', 'title': 'Standard Care (Control) Arm', 'description': 'Lesion size (total lesion area) of participants in the Standard Care alone monitoring arm at time of CNV detection'}], 'classes': [{'categories': [{'measurements': [{'value': '0.23', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.91'}, {'value': '0.70', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1.50'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '2 years', 'description': 'Median lesion size (total lesion area) at time of confirmed progression to CNV as measured on fluorescein angiography (FA) will be compared between the two study arms. Lesion size was assessed, measured, and reported by optic disc areas, where 1 disc area = 2.54 mm\\^2.', 'unitOfMeasure': 'Disc Areas', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 51 patients who progressed to CNV in the device arm, 39 had an FA performed, and of 30 patients who progressed to CNV in the standard care alone arm, 23 had an FA performed. Patients that progressed to CNV and had FAs performed were analyzed in this secondary analysis.'}, {'type': 'SECONDARY', 'title': 'Secondary Outcome: Lesion Size (CNV Area) at Time of Confirmed Progression to CNV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Device Monitoring Arm', 'description': 'Lesion size (CNV lesion area) of participants in the ForeseeHome use + Standard Care monitoring arm at time of CNV detection'}, {'id': 'OG001', 'title': 'Standard Care (Control) Arm', 'description': 'Lesion size (CNV lesion area) of participants in the Standard Care alone monitoring arm at time of CNV detection'}], 'classes': [{'categories': [{'measurements': [{'value': '0.17', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.69'}, {'value': '0.60', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1.50'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '2 years', 'description': 'Median lesion size (CNV area) at time of confirmed progression to CNV as measured on fluorescein angiography will be compared between the two study arms. Lesion size was assessed, measured, and reported by optic disc areas, where 1 disc area = 2.54 mm\\^2.', 'unitOfMeasure': 'Disc Areas', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 51 patients who progressed to CNV in the device arm, 39 had an FA performed, and of 30 patients who progressed to CNV in the standard care alone arm, 23 had an FA performed. Patients that progressed to CNV and had FAs performed were analyzed in this secondary analysis.'}, {'type': 'SECONDARY', 'title': 'Secondary Outcome: Lesion Size (Fluid Area) at Time of Confirmed Progression to CNV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Device Monitoring Arm', 'description': 'Lesion size (fluid area) of participants in the ForeseeHome use + Standard Care monitoring arm at time of CNV detection'}, {'id': 'OG001', 'title': 'Standard Care (Control) Arm', 'description': 'Lesion size (fluid area) of participants in the Standard Care alone monitoring arm at time of CNV detection'}], 'classes': [{'categories': [{'measurements': [{'value': '0.55', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1.15'}, {'value': '0.90', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2.20'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '2 years', 'description': 'Median lesion size (fluid area) at time of confirmed progression to CNV as measured on fluorescein angiography will be compared between the two study arms. Lesion size was assessed, measured, and reported by optic disc areas, where 1 disc area = 2.54 mm\\^2.', 'unitOfMeasure': 'Disc Areas', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '51 of 763 patients progressed to CNV in the device arm and 30 of 757 patients progressed to CNV in the standard care alone arm. Patients that progressed to CNV were analyzed in this secondary analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Device Monitoring Arm', 'description': 'Participants in the device monitoring arm will receive a packed device at home, with instructions to install and connect the device to a modem as well as instructions for daily use of the device.'}, {'id': 'FG001', 'title': 'Standard Care (Control) Arm', 'description': 'Standard care instruction per clinic routine for home vision monitoring to detect progression of AMD.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '763'}, {'groupId': 'FG001', 'numSubjects': '757'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '739'}, {'groupId': 'FG001', 'numSubjects': '737'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '20'}]}]}], 'recruitmentDetails': '1970 Participants 53-90 Years of age at high risk of CNV developing were screened of these 1520 with mean age of 72.5 were enrolled at 44 clinical centers'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '763', 'groupId': 'BG000'}, {'value': '757', 'groupId': 'BG001'}, {'value': '1520', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Device Monitoring Arm', 'description': 'participants in the device monitoring arm will receive a packed device at home, with instructions to install and connect the device to a modem as well as instructions for daily use of the device.\n\nForeseeHome'}, {'id': 'BG001', 'title': 'Standard Care (Control) Arm', 'description': 'Standard care instruction per clinic routine for home vision monitoring to detect progression of AMD.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '659', 'groupId': 'BG000'}, {'value': '646', 'groupId': 'BG001'}, {'value': '1305', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72.6', 'spread': '7.7', 'groupId': 'BG000'}, {'value': '72.3', 'spread': '7.7', 'groupId': 'BG001'}, {'value': '72.5', 'spread': '7.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '444', 'groupId': 'BG000'}, {'value': '451', 'groupId': 'BG001'}, {'value': '895', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '319', 'groupId': 'BG000'}, {'value': '306', 'groupId': 'BG001'}, {'value': '625', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '763', 'groupId': 'BG000'}, {'value': '757', 'groupId': 'BG001'}, {'value': '1520', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'At baseline, all participants underwent Best corrected visual acuity testing and color fundus photography of 3 stereoscopic fields in both eyes.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1520}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-16', 'studyFirstSubmitDate': '2010-04-12', 'resultsFirstSubmitDate': '2015-05-04', 'studyFirstSubmitQcDate': '2010-04-13', 'lastUpdatePostDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-06-27', 'studyFirstPostDateStruct': {'date': '2010-04-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Outcome: Change in Visual Acuity (LogMAR Letters) From Baseline to Detection of Choroidal Neovascularization', 'timeFrame': '2 years', 'description': 'Mean change in BCVA (logMAR letters) from baseline to the time of confirmed progression to CNV in the ForeseeHome device monitoring group compared to the standard care group.'}], 'secondaryOutcomes': [{'measure': 'Secondary Outcome: Patients Who Maintained 20/40 or Better Vision at Time of CNV Detection', 'timeFrame': '2 years', 'description': 'Percent of patients who maintained 20/40 or better vision at the time of CNV detection in each study arm'}, {'measure': 'Secondary Outcome: Lesion Size (Total Lesion Area) at Time of Confirmed Progression to CNV', 'timeFrame': '2 years', 'description': 'Median lesion size (total lesion area) at time of confirmed progression to CNV as measured on fluorescein angiography (FA) will be compared between the two study arms. Lesion size was assessed, measured, and reported by optic disc areas, where 1 disc area = 2.54 mm\\^2.'}, {'measure': 'Secondary Outcome: Lesion Size (CNV Area) at Time of Confirmed Progression to CNV', 'timeFrame': '2 years', 'description': 'Median lesion size (CNV area) at time of confirmed progression to CNV as measured on fluorescein angiography will be compared between the two study arms. Lesion size was assessed, measured, and reported by optic disc areas, where 1 disc area = 2.54 mm\\^2.'}, {'measure': 'Secondary Outcome: Lesion Size (Fluid Area) at Time of Confirmed Progression to CNV', 'timeFrame': '2 years', 'description': 'Median lesion size (fluid area) at time of confirmed progression to CNV as measured on fluorescein angiography will be compared between the two study arms. Lesion size was assessed, measured, and reported by optic disc areas, where 1 disc area = 2.54 mm\\^2.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['AMD', 'CNV'], 'conditions': ['Age Related Macular Degeneration']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.notalvision.com', 'label': 'Sponsor Home Page'}, {'url': 'http://www.areds2.org/', 'label': 'AREDS2 page'}]}, 'descriptionModule': {'briefSummary': 'The overall objective of this two arm randomized clinical trial (RCT) is to determine if home monitoring using the comprehensive visual field and telemedicine solution based on the ForeseeHome device in AREDS2 improves detection of progression to choroidal neovascularization (CNV) when compared with standard care.', 'detailedDescription': 'The overall objective of this two arm randomized clinical trial (RCT) is to determine if home monitoring using the comprehensive visual field and telemedicine solution based on the ForeseeHome device in AREDS2 (referred to as the ForeseeHome comprehensive solution) participants at high risk of progression to neovascular AMD improves detection of progression to choroidal neovascularization (CNV) when compared with standard care. The primary outcome of this study is presenting best corrected visual acuity (BCVA) at the time of CNV diagnosis. Secondary outcomes include time to confirmed CNV diagnosis, lesion size, lesion location (extrafoveal, juxtafoveal, or subfoveal), lesion type (occult without classic, predominantly classic or minimally classic), sensitivity and specificity, and BCVA following three consecutive months of treatment and twelve months after the initial start of CNV treatment with an intravitreal anti-VEGF agent using either ranibizumab or bevacizumab. Outcomes will be ascertained via the following specific aims:'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "INCLUSION CRITERIA:\n\n* Male or female participant between 55 and 90 years of age. Participants must have bilateral large drusen (at least 125 micron), or large drusen in the posterior pole in one eye (study eye) and advanced AMD (neovascular AMD or central geographic atrophy) in the fellow eye as determined by their study ophthalmologist. Likelihood, willingness, and ability to return for multiple visits (potentially within the same month) for at least 2 years.\n* Participant must be English speaking and understand and sign the protocol's informed consent document.\n* Participant must be able to successfully demonstrate their ability to comprehend instructions and use of the ForeseeHome device (a ForeseeHome device will be available at the clinic for the participant to demonstrate their ability).\n* Participant's address to which the ForeseeHome device will be sent, if randomized to the device monitoring arm, must be located in the U.S.A.\n* Study eye(s) must have best corrected visual acuity 20/60 or better (at least 54 letters).\n* Ocular media sufficient to allow adequate quality fundus photography.\n* Participant must be willing to have name and contact information provided to Notal Vision.\n* Participant must consent to be examined by the study ophthalmologist when changes in symptoms are detected by the home-device or by standard of care or when unreliable test results occur during the usage period.\n* If randomized to the device monitoring arm, participant must agree to take the device with them if staying somewhere else other than their primary residence for 14 days or more.\n\nEXCLUSION CRITERIA:\n\n* Participant has evidence of macular or retinal disorders other than AMD in the study eye(s).\n* Participant has known adverse reaction to fluorescein dye or refuses further fluorescein angiograms.\n* Participant's eye is receiving (or is expected to receive) an eye examination on a continuing basis by an eye care professional more frequently than every four months\n* NonAREDS2 participant currently enrolled in another study that may likely affect adherence with The HOME Study\n* Previous retinal or other ocular surgical procedures, the effects of which may now or in the future complicate assessment of the progression of AMD in the study eye.\n* Chronic requirement for any systemic or ocular medication administered for other diseases\n* Cataract surgery within one month of randomization.\n* Participant that has any condition that would make adherence to study follow up procedures for at least one year difficult or unlikely"}, 'identificationModule': {'nctId': 'NCT01103505', 'acronym': 'AREDS', 'briefTitle': 'HOme Vision Monitoring in AREDS2 for Progression to Neovascular AMD Using the ForeseeHome Device', 'nctIdAliases': ['NCT01314430'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Notal Vision Inc.'}, 'officialTitle': 'The HOME Study: HOme Vision Monitoring in AREDS2 for Progression to Neovascular AMD Using the ForeseeHome Device - (HOme Monitoring of the Eye)', 'orgStudyIdInfo': {'id': 'ForeseeHome AREDS2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'ForeseeHome AMD Monitoring Device', 'description': 'Participants in the device monitoring arm will receive a packed device at home, with instructions to install and connect the device to a modem as well as instructions for daily use of the device in addition to standard care', 'interventionNames': ['Diagnostic Test: ForeseeHome AMD Monitoring Device']}, {'type': 'NO_INTERVENTION', 'label': 'Standard care alone (control) arm', 'description': 'Standard care instruction per clinic routine for home vision monitoring to detect progression of AMD and routine eye exams'}], 'interventions': [{'name': 'ForeseeHome AMD Monitoring Device', 'type': 'DIAGNOSTIC_TEST', 'description': 'Earlier detection of progression from intermediate dry age-related macular degeneration to CNV between routine eye exams through home diagnostic testing with the ForeseeHome AMD Monitoring device', 'armGroupLabels': ['ForeseeHome AMD Monitoring Device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Jones Eye Institute - UAMS', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Shiley Eye Center - UCSD', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda Univ.', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Univ. of California, Davis', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '80230', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Retina Assoc.', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80027', 'city': 'Louisville', 'state': 'Colorado', 'country': 'United States', 'facility': 'Eldorado Retina Associates', 'geoPoint': {'lat': 39.97776, 'lon': -105.13193}}, {'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Univ. Eye Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Univ. of Florida Health Science Center', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Bascom Palmer Eye Institute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Sarasota Retina Institute', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory Univ. Eye Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30030', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia Retina, P.C.', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '40509', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Retina Associates of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '21237', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Elman Retina Group, PA', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Wilmer Eye Institute', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '20815', 'city': 'Chevy Chase', 'state': 'Maryland', 'country': 'United States', 'facility': 'Retina Group of Washington', 'geoPoint': {'lat': 39.00287, 'lon': -77.07115}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Ophthalmic Cons. of Boston', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Kresge Eye Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '49546', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Vision Research Foundation', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'Vision Research Foundation', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '49684', 'city': 'Traverse City', 'state': 'Michigan', 'country': 'United States', 'facility': 'Vision Research Foundation', 'geoPoint': {'lat': 44.76306, 'lon': -85.62063}}, {'city': 'Lawrenceville', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Delaware Valley Retina Associates', 'geoPoint': {'lat': 40.29733, 'lon': -74.7296}}, {'zip': '12159', 'city': 'Slingerlands', 'state': 'New York', 'country': 'United States', 'facility': 'Retina Research Foundation', 'geoPoint': {'lat': 42.62925, 'lon': -73.86457}}, {'zip': '28210', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Charlotte Eye Ear Nose and Throat Assoc', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Univ.', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case Western Reserve Univ.', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44122', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Retina Assoc. of Cleveland', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '17011', 'city': 'Camp Hill', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pennsylvania Retina Specialists, P.C.', 'geoPoint': {'lat': 40.23981, 'lon': -76.91997}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State M.S. Hershey Med Ctr', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Scheie Eye Institute', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Eye Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '38103', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Univ. of Tennessee HSC', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Retina Associates', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Retina Consult. of Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '79410', 'city': 'Lubbock', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Retina Associates', 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'John Moran Eye Center, Univ. of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Univ. of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Emily Chew, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'National Eye Institute (NEI)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Notal Vision Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}