Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2026-01-29 @ 2:03 PM
Study NCT ID:
NCT02569892
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
2015-10-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Non-Damaging Photothermal Therapy of Non-exudative Age Related Macular Degeneration
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D015593', 'term': 'Retinal Drusen'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ssanislo@stanford.edu', 'phone': '650-723-6995', 'title': 'Steven Sanislo, MD', 'organization': 'Stanford University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'This study did not meet enrollment goal of 60 study eyes.'}}, 'adverseEventsModule': {'timeFrame': '24 months', 'description': 'Per protocol, only adverse events related to treatment were collected. Participants who contributed more than one eye are counted in more than one reporting group.', 'eventGroups': [{'id': 'EG000', 'title': 'Sub-threshold Macular Laser Photocoagulation', 'description': 'Participants that receive treatment with sub-threshold macular laser photocoagulation', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham Laser', 'description': 'Participants that receive sham treatment with sub-threshold macular laser photocoagulation (with power setting at zero)', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'mild supra-threshold laser burns', 'notes': 'Laser burns in this study were to be sub-threshold (non-visible).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Macular Drusen Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sub-threshold Macular Laser Photocoagulation', 'description': 'Participants that receive treatment with sub-threshold macular laser photocoagulation'}, {'id': 'OG001', 'title': 'Sham Laser', 'description': 'Participants that receive sham treatment with sub-threshold macular laser photocoagulation (with power setting at zero)'}], 'classes': [{'title': 'Baseline volume', 'categories': [{'measurements': [{'value': '0.05', 'groupId': 'OG000', 'lowerLimit': '0.05', 'upperLimit': '0.14'}, {'value': '0.11', 'groupId': 'OG001', 'lowerLimit': '0.07', 'upperLimit': '0.13'}]}]}, {'title': '6 month change', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '6.04', 'upperLimit': '33.30'}, {'value': '9.0', 'groupId': 'OG001', 'lowerLimit': '-55.50', 'upperLimit': '25.00'}]}]}, {'title': '12 month change', 'categories': [{'measurements': [{'value': '42.2', 'groupId': 'OG000', 'lowerLimit': '25.00', 'upperLimit': '55.01'}, {'value': '27.2', 'groupId': 'OG001', 'lowerLimit': '-85.70', 'upperLimit': '46.20'}]}]}, {'title': '24 month change', 'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000', 'lowerLimit': '34.75', 'upperLimit': '135.00'}, {'value': '-4.5', 'groupId': 'OG001', 'lowerLimit': '-85.70', 'upperLimit': '81.80'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline, 6, 12, and 24 months', 'description': 'Mean change in macular drusen volume as measured on high-resolution spectral domain ocular coherence tomography (SD-OCT)', 'unitOfMeasure': 'mm^3', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Participants who contributed more than one eye are counted in more than one reporting group. Data for the participant who did not complete the study are included using the Last Observation Carried Forward (LOCF) method.'}, {'type': 'SECONDARY', 'title': 'Change in Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sub-threshold Macular Laser Photocoagulation', 'description': 'Participants that receive treatment with sub-threshold macular laser photocoagulation'}, {'id': 'OG001', 'title': 'Sham Laser', 'description': 'Participants that receive sham treatment with sub-threshold macular laser photocoagulation (with power setting at zero)'}], 'classes': [{'title': 'Baseline vision', 'categories': [{'measurements': [{'value': '81.7', 'spread': '8.60', 'groupId': 'OG000'}, {'value': '79.4', 'spread': '5.19', 'groupId': 'OG001'}]}]}, {'title': '6 month change', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '4.24', 'groupId': 'OG000'}, {'value': '-3.4', 'spread': '4.67', 'groupId': 'OG001'}]}]}, {'title': '12 month change', 'categories': [{'measurements': [{'value': '-2.7', 'spread': '324', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '3.95', 'groupId': 'OG001'}]}]}, {'title': '24 month change', 'categories': [{'measurements': [{'value': '-3.6', 'spread': '6.10', 'groupId': 'OG000'}, {'value': '-6.3', 'spread': '6.96', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6, 12, and 24 months', 'description': 'Mean change in best-corrected visual acuity as measured using early treatment diabetic retinopathy study (ETDRS) chart - average number of letters seen on chart', 'unitOfMeasure': 'Letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Participants who contributed more than one eye are counted in more than one reporting group. Data for the participant who did not complete the study are included using the Last Observation Carried Forward (LOCF) method.'}, {'type': 'SECONDARY', 'title': 'Development of Geographic Atrophy (GA) or Choroidal Neovascularization (CNV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sub-threshold Macular Laser Photocoagulation', 'description': 'Participants that receive treatment with sub-threshold macular laser photocoagulation'}, {'id': 'OG001', 'title': 'Sham Laser', 'description': 'Participants that receive sham treatment with sub-threshold macular laser photocoagulation (with power setting at zero)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '2 years', 'description': 'Count of eyes that develop geographic atrophy or choroidal neovascularization by 24 months.', 'unitOfMeasure': 'Eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Participants who contributed more than one eye are counted in more than one reporting group. Data for the participant who did not complete the study are included using the Last Observation Carried Forward (LOCF) method.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sub-threshold Macular Laser Photocoagulation', 'description': 'Participants that receive treatment with sub-threshold macular laser photocoagulation'}, {'id': 'FG001', 'title': 'Sham Laser', 'description': 'Participants that receive sham treatment with sub-threshold macular laser photocoagulation (with power setting at zero)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '10', 'numSubjects': '10'}, {'groupId': 'FG001', 'numUnits': '9', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '10', 'numSubjects': '10'}, {'groupId': 'FG001', 'numUnits': '8', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '1', 'numSubjects': '1'}]}]}], 'typeUnitsAnalyzed': 'Eyes', 'recruitmentDetails': 'Participants recruited from January 2016 until May 2018, at which time interim analysis revealed futility.', 'preAssignmentDetails': '19 participants signed informed consent; 2 participants failed screening, and 17 participants started the study. Participants may have contributed one or both eyes to the study. If both eyes were enrolled the first eye would be randomly assigned to treatment or sham, and the fellow eye would be assigned to the opposite treatment arm. Participants who contributed more than one eye are counted in more than one reporting group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'Participants receive sub-threshold macular laser photocoagulation and/or sham treatment with power setting at zero'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Randomized participants'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-15', 'size': 312623, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-02-24T16:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-13', 'studyFirstSubmitDate': '2015-10-05', 'resultsFirstSubmitDate': '2021-03-09', 'studyFirstSubmitQcDate': '2015-10-06', 'lastUpdatePostDateStruct': {'date': '2021-10-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-27', 'studyFirstPostDateStruct': {'date': '2015-10-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Macular Drusen Volume', 'timeFrame': 'baseline, 6, 12, and 24 months', 'description': 'Mean change in macular drusen volume as measured on high-resolution spectral domain ocular coherence tomography (SD-OCT)'}], 'secondaryOutcomes': [{'measure': 'Change in Visual Acuity', 'timeFrame': 'baseline, 6, 12, and 24 months', 'description': 'Mean change in best-corrected visual acuity as measured using early treatment diabetic retinopathy study (ETDRS) chart - average number of letters seen on chart'}, {'measure': 'Development of Geographic Atrophy (GA) or Choroidal Neovascularization (CNV)', 'timeFrame': '2 years', 'description': 'Count of eyes that develop geographic atrophy or choroidal neovascularization by 24 months.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Macular Degeneration', 'Retinal Drusen']}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled study of non-damaging photothermal macular grid laser versus sham laser therapy in patients with dry age-related macular degeneration (AMD) and large high-risk drusen. The goal of the study is to determine if this treatment will reduce macular drusen volume and also whether this might improve visual acuity or reduce the risk of conversion to advanced age-related macular degeneration defined as development of choroidal neovascularization or geographic atrophy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n1. Older than 60 years of age.\n2. Male or female patients with nonexudative AMD with a drusen volume of of at least 0.03mm3 in the central 3mm circle\n3. Adequate pupil dilatation and clear media to perform colour, red-free imaging and fundus fluorescein angiography, fundus autofluorescence imaging and OCT.\n4. Able to give an informed consent.\n\nExclusion Criteria:\n\n1. Presence of signs of advanced AMD, such as CNV, haemorrhages or macular atrophy based on OCT and fundus autofluorescence photography (FAF).\n2. Previous macular laser treatment.\n3. Any previous ocular condition that may be associated with a risk of developing macular oedema.\n4. Vitreomacular traction determined clinically and /or by OCT, which in the opinion of the investigator, contributes to the macular oedema (associated or causing a detachment of the fovea).\n5. Presence of other macular disease such as epiretinal membrane, macular telangiectasia.\n6. Important known allergies to sodium fluorescein dye used in angiography.\n7. Ocular or periocular infections.\n8. Planned intra-ocular surgery within one year.\n9. Patient is unavailable for follow-up visits.'}, 'identificationModule': {'nctId': 'NCT02569892', 'briefTitle': 'Non-Damaging Photothermal Therapy of Non-exudative Age Related Macular Degeneration', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Non-Damaging Photothermal Therapy of Non-exudative Age Related Macular Degeneration', 'orgStudyIdInfo': {'id': 'IRB-33991'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laser Arm', 'description': 'Participants receive treatment with sub-threshold macular laser photocoagulation', 'interventionNames': ['Device: Pascal Retinal Laser Photocoagulator']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Laser Arm', 'description': 'Participants receive sham treatment with sub-threshold macular laser photocoagulation (with power setting at zero)', 'interventionNames': ['Device: Pascal Retinal Laser Photocoagulator']}], 'interventions': [{'name': 'Pascal Retinal Laser Photocoagulator', 'type': 'DEVICE', 'description': 'Sub-threshold macular laser treatment with Pascal laser Endpoint Management System', 'armGroupLabels': ['Laser Arm', 'Sham Laser Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94303', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Byers Eye Institute at Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'overallOfficials': [{'name': 'Steven Sanislo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bascom Palmer Eye Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Steven R. Sanislo', 'investigatorAffiliation': 'Stanford University'}}}}