Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-03 @ 11:49 AM
Study NCT ID:
NCT02800356
Status:
COMPLETED
Last Update Posted:
2025-03-20
First Post:
2016-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Subthreshold Laser Treatment for Reticular Pseudodrusen and Geographic Atrophy Secondary to AMD
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D057092', 'term': 'Geographic Atrophy'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'querques.giuseppe@hsr.it', 'phone': '00390226434004', 'title': 'Prof. Giuseppe Querques', 'organization': 'San Raffaele Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Pseudodrusen', 'description': 'Patients affected by reticular pseudodrusen secondary to AMD were included and treated by subthreshold 577 nm yellow wavelength laser photo-coagulator.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Retinal Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pseudodrusen', 'description': 'Patients affected by reticular pseudodrusen secondary to AMD were included and treated by subthreshold 577 nm yellow wavelength laser photo-coagulator.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '12.08', 'spread': '4.65', 'groupId': 'OG000'}]}]}, {'title': '4 weeks', 'categories': [{'measurements': [{'value': '11.08', 'spread': '5.06', 'groupId': 'OG000'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '11.45', 'spread': '5.70', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.404', 'groupIds': ['OG000'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Analysis of Variance (ANOVA) for paired samples with Bonferroni post-hoc analysis'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4 weeks and 12 weeks', 'description': 'Change in retinal sensitivity on customized microperimetry (treated area).', 'unitOfMeasure': 'dB', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pseudodrusen', 'description': 'Patients affected by reticular pseudodrusen secondary to AMD were included and treated by subthreshold 577 nm yellow wavelength laser photo-coagulator.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.14', 'spread': '0.09', 'groupId': 'OG000'}]}]}, {'title': '4 weeks', 'categories': [{'measurements': [{'value': '0.135', 'spread': '0.10', 'groupId': 'OG000'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '0.115', 'spread': '0.09', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.232', 'groupIds': ['OG000'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Analysis of Variance (ANOVA) for paired samples with Bonferroni post-hoc analysis'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4 weeks and 12 weeks', 'description': 'Change in mean Visual Acuity', 'unitOfMeasure': 'LogMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Thickness of the Outer Nuclear Layer in the Treated Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pseudodrusen', 'description': 'Patients affected by reticular pseudodrusen secondary to AMD were included and treated by subthreshold 577 nm yellow wavelength laser photo-coagulator.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '59.30', 'spread': '13.50', 'groupId': 'OG000'}]}]}, {'title': '4 weeks', 'categories': [{'measurements': [{'value': '64.75', 'spread': '12.31', 'groupId': 'OG000'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '67.75', 'spread': '15.52', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Analysis of Variance (ANOVA) for paired samples with Bonferroni post-hoc analysis'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4 weeks and 12 weeks', 'description': 'The thickness of the outer nuclear layer in the treated area was measured using structural OCT', 'unitOfMeasure': 'µm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Partecipants With Adverse and Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pseudodrusen', 'description': 'Patients affected by reticular pseudodrusen secondary to AMD were included and treated by subthreshold 577 nm yellow wavelength laser photo-coagulator.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 weeks and 12 weeks', 'description': 'Adverse and Serious Adverse Events were recorded', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Partecipants With Presence of Haemorrhage, Photocoagulation Spots, Ischemic Areas', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pseudodrusen', 'description': 'Patients affected by reticular pseudodrusen secondary to AMD were included and treated by subthreshold 577 nm yellow wavelength laser photo-coagulator.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 weeks and 12 weeks', 'description': 'Fundus examination by using slit-lamp was performed in order to assess the presence of hemorrhage, photocoagulation spots, ischemic areas', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Intraocular Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pseudodrusen', 'description': 'Patients affected by reticular pseudodrusen secondary to AMD were included and treated by subthreshold 577 nm yellow wavelength laser photo-coagulator.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '15.5', 'spread': '2.9', 'groupId': 'OG000'}]}]}, {'title': '4 weeks', 'categories': [{'measurements': [{'value': '14.9', 'spread': '2.4', 'groupId': 'OG000'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '14.7', 'spread': '2.4', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.267', 'groupIds': ['OG000'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Analysis of Variance (ANOVA) for paired samples with Bonferroni post-hoc analysis'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks and 12 weeks', 'description': 'Intraocular pressure was recorded.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pseudodrusen', 'description': 'Patients affected by reticular pseudodrusen secondary to AMD were included and treated by subthreshold 577 nm yellow wavelength laser photo-coagulator.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Pseudodrusen', 'description': 'Patients affected by reticular pseudodrusen secondary to AMD were included and treated by subthreshold 577 nm yellow wavelength laser photo-coagulator.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '78.4', 'spread': '6.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Italy', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Retinal sensitivity in the treated area', 'classes': [{'categories': [{'measurements': [{'value': '12.08', 'spread': '4.65', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'dB', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-01', 'size': 41979, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-02-02T14:42', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-11', 'studyFirstSubmitDate': '2016-06-02', 'resultsFirstSubmitDate': '2020-02-02', 'studyFirstSubmitQcDate': '2016-06-10', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-02', 'studyFirstPostDateStruct': {'date': '2016-06-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retinal Sensitivity', 'timeFrame': 'Baseline, 4 weeks and 12 weeks', 'description': 'Change in retinal sensitivity on customized microperimetry (treated area).'}], 'secondaryOutcomes': [{'measure': 'Visual Acuity', 'timeFrame': 'Baseline, 4 weeks and 12 weeks', 'description': 'Change in mean Visual Acuity'}, {'measure': 'The Thickness of the Outer Nuclear Layer in the Treated Area', 'timeFrame': 'Baseline, 4 weeks and 12 weeks', 'description': 'The thickness of the outer nuclear layer in the treated area was measured using structural OCT'}, {'measure': 'Number of Partecipants With Adverse and Serious Adverse Events', 'timeFrame': '4 weeks and 12 weeks', 'description': 'Adverse and Serious Adverse Events were recorded'}, {'measure': 'Number of Partecipants With Presence of Haemorrhage, Photocoagulation Spots, Ischemic Areas', 'timeFrame': '4 weeks and 12 weeks', 'description': 'Fundus examination by using slit-lamp was performed in order to assess the presence of hemorrhage, photocoagulation spots, ischemic areas'}, {'measure': 'Intraocular Pressure', 'timeFrame': '4 weeks and 12 weeks', 'description': 'Intraocular pressure was recorded.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Age-Related Macular Degeneration', 'Geographic Atrophy', 'Reticular pseudodrusen', 'Lasers', 'PASCAL 577'], 'conditions': ['Age-Related Macular Degeneration', 'Geographic Atrophy', 'Reticular Pseudodrusen']}, 'referencesModule': {'references': [{'pmid': '15615751', 'type': 'BACKGROUND', 'citation': 'Luttrull JK, Musch DC, Mainster MA. Subthreshold diode micropulse photocoagulation for the treatment of clinically significant diabetic macular oedema. Br J Ophthalmol. 2005 Jan;89(1):74-80. doi: 10.1136/bjo.2004.051540.'}, {'pmid': '16996596', 'type': 'BACKGROUND', 'citation': 'Parodi MB, Spasse S, Iacono P, Di Stefano G, Canziani T, Ravalico G. Subthreshold grid laser treatment of macular edema secondary to branch retinal vein occlusion with micropulse infrared (810 nanometer) diode laser. Ophthalmology. 2006 Dec;113(12):2237-42. doi: 10.1016/j.ophtha.2006.05.056. Epub 2006 Sep 25.'}, {'pmid': '19041477', 'type': 'BACKGROUND', 'citation': 'Chen SN, Hwang JF, Tseng LF, Lin CJ. Subthreshold diode micropulse photocoagulation for the treatment of chronic central serous chorioretinopathy with juxtafoveal leakage. Ophthalmology. 2008 Dec;115(12):2229-34. doi: 10.1016/j.ophtha.2008.08.026.'}, {'pmid': '24837050', 'type': 'BACKGROUND', 'citation': 'Luttrull JK, Sinclair SH. Safety of transfoveal subthreshold diode micropulse laser for fovea-involving diabetic macular edema in eyes with good visual acuity. Retina. 2014 Oct;34(10):2010-20. doi: 10.1097/IAE.0000000000000177.'}, {'pmid': '25650711', 'type': 'BACKGROUND', 'citation': 'Luttrull JK, Chang DB, Margolis BW, Dorin G, Luttrull DK. LASER RESENSITIZATION OF MEDICALLY UNRESPONSIVE NEOVASCULAR AGE-RELATED MACULAR DEGENERATION: Efficacy and Implications. Retina. 2015 Jun;35(6):1184-94. doi: 10.1097/IAE.0000000000000458.'}, {'pmid': '25719988', 'type': 'BACKGROUND', 'citation': 'Vujosevic S, Martini F, Longhin E, Convento E, Cavarzeran F, Midena E. SUBTHRESHOLD MICROPULSE YELLOW LASER VERSUS SUBTHRESHOLD MICROPULSE INFRARED LASER IN CENTER-INVOLVING DIABETIC MACULAR EDEMA: Morphologic and Functional Safety. Retina. 2015 Aug;35(8):1594-603. doi: 10.1097/IAE.0000000000000521.'}, {'pmid': '16340527', 'type': 'BACKGROUND', 'citation': 'Bessho K, Rodanant N, Bartsch DU, Cheng L, Koh HJ, Freeman WR. Effect of subthreshold infrared laser treatment for drusen regression on macular autofluorescence in patients with age-related macular degeneration. Retina. 2005 Dec;25(8):981-8. doi: 10.1097/00006982-200512000-00005.'}, {'pmid': '26493180', 'type': 'BACKGROUND', 'citation': 'Virgili G, Michelessi M, Parodi MB, Bacherini D, Evans JR. Laser treatment of drusen to prevent progression to advanced age-related macular degeneration. Cochrane Database Syst Rev. 2015 Oct 23;2015(10):CD006537. doi: 10.1002/14651858.CD006537.pub3.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the effectiveness of subthreshold laser treatment on retinal sensitivity in patients with reticular pseudodrusen and incipient Geographic Atrophy (GA) secondary to Age-Related Macular Degeneration (AMD). Secondary objective is to investigate changes in best-corrected visual acuity, atrophy progression and safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* GA \\< 0.5 disk areas secondary to AMD and/or Reticular pseudodrusen\n* 50 years or older\n* The periphery of the atrophic lesions must demonstrate increased autofluorescence\n* Best corrected visual acuity between 20/20 and 20/400 inclusive\n* Clear ocular media\n* Ability to provide informed consent and attend all study visits\n\nExclusion Criteria:\n\n* GA secondary to other causes aside from AMD\n* Evidence of choroidal neovascularization in either eye\n* Any prior treatment for AMD, aside from antioxidants\n* Any other ocular condition that would progress in the study period and confound visual acuity assessment\n* Any ocular or systemic medication known to be toxic to the lens, retina or optic nerve\n* Presence of idiopathic or autoimmune-associated uveitis\n* Any intraocular surgery 3 months of entry\n* Any prior thermal laser in the macula\n* History of vitrectomy, filtering surgery, corneal transplant or retinal detachment surgery\n* Previous therapeutic radiation in the ocular region in either eye\n* Any treatment with an investigational agent in the previous 60 days before study entry\n* Women of child-bearing potential, defined as all women less than 1 year postmenopausal or less than 6 weeks since sterilization at Baseline, unless they are using highly effective methods of contraception during dosing of study treatment\n* Participation in an investigational drug, biologic, or device study within 6 Months prior to Baseline \\[Note: observational clinical studies solely involving over-the-counter vitamins, supplements, or diets are not exclusionary'}, 'identificationModule': {'nctId': 'NCT02800356', 'briefTitle': 'Subthreshold Laser Treatment for Reticular Pseudodrusen and Geographic Atrophy Secondary to AMD', 'organization': {'class': 'OTHER', 'fullName': 'Ospedale San Raffaele'}, 'officialTitle': 'Subthreshold Laser Treatment for Reticular Pseudodrusen and Incipient Geographic Atrophy Secondary to Age - Related Macular Degeneration: a Pilot Study', 'orgStudyIdInfo': {'id': 'PASCAL-GA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pseudodrusen', 'description': 'Subthreshold 577 nm yellow wavelength laser photo-coagulator', 'interventionNames': ['Procedure: Subthreshold 577 nm yellow wavelength laser photo-coagulator']}, {'type': 'EXPERIMENTAL', 'label': 'Geographic atrophy', 'description': 'Subthreshold 577 nm yellow wavelength laser photo-coagulator', 'interventionNames': ['Procedure: Subthreshold 577 nm yellow wavelength laser photo-coagulator']}], 'interventions': [{'name': 'Subthreshold 577 nm yellow wavelength laser photo-coagulator', 'type': 'PROCEDURE', 'otherNames': ['Pascal Synthesis 577 (Topcon)', 'Subthreshold laser'], 'description': 'Subthreshold photocoagulation is a method in which the burn spots (treated areas) cannot be seen with biomicroscopy, on color fundus photograph, on Optical Coherence Tomography or Fluorescein Angiography when the subthreshold level is adequately set. Subthreshold photocoagulation can be considered to be truly minimally invasive or non-damaging photocoagulation. A term sometimes used is photo-thermal stimulation since the Retinal Pigment Epithelium (RPE) layer is heated and stimulated, but not destroyed.\n\nThe threshold level output power is set to obtain barely visible burn at approximately 200 mW to 250 mW using the titration mode, and irradiation is conducted after switching over to Endpoint Management.', 'armGroupLabels': ['Geographic atrophy', 'Pseudodrusen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20132', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'facility': 'Ospedale San Raffaele', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Giuseppe Querques, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ospedale San Raffaele'}, {'name': 'Riccardo Sacconi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ospedale San Raffaele'}, {'name': 'Francesco Gelormini, MDs', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ospedale San Raffaele'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ospedale San Raffaele', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head-Medical retina & Imaging unit', 'investigatorFullName': 'Querques Giuseppe', 'investigatorAffiliation': 'Ospedale San Raffaele'}}}}