Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2026-03-06 @ 5:45 AM
Study NCT ID:
NCT02799992
Status:
UNKNOWN
Last Update Posted:
2016-06-15
First Post:
2016-06-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pseudo-PDT in Central Serous Chorioretinopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-06-09', 'studyFirstSubmitDate': '2016-06-06', 'studyFirstSubmitQcDate': '2016-06-09', 'lastUpdatePostDateStruct': {'date': '2016-06-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best-corrected Visual Acuity (LogMAR)', 'timeFrame': '6 months', 'description': 'Measured with ETDRS chart'}, {'measure': 'Central Retinal Thickness (micron)', 'timeFrame': '6 months', 'description': 'Measured with OCT'}, {'measure': 'Subfoveal Choroidal Thickness (micron)', 'timeFrame': '6 months', 'description': 'Measured with OCT'}], 'secondaryOutcomes': [{'measure': 'Ellipsoid Zone Recovery (integrity of IS/OS line)', 'timeFrame': '6 months', 'description': 'As visible with OCT scans'}]}, 'conditionsModule': {'conditions': ['Chronic Central Serous Chorioretinopathy']}, 'descriptionModule': {'briefSummary': 'Acute central serous chorioretinopathy (CSC) is a common disorder in middle-aged patients, characterized by serous retinal detachment in the macular region. We evaluated half-dose verteporfin photodynamic therapy (hd-PDT) versus 689 nm laser treatment in chronic CSC.\n\nTwenty-two eyes of 22 patients with symptomatic chronic CSC were randomized in a 1:1 ratio to receive hd-PDT (group 1) or 689-LT delivering 95 J/cm2 by application of an intensity of 805 mW/cm2 over 118 seconds. Best-corrected visual acuity (BCVA) and spectral-domain optical coherence tomography findings were compared between groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥18 years;\n* patients with best-corrected visual acuity (BCVA) of 20/200 or better;\n* presence of subretinal fluid (SRF) and/or serous pigment epithelial detachment involving the fovea on optical coherence tomography (OCT);\n* presence of active angiographic leakage in fluorescein angiography caused by CSC and no other diseases, and abnormal dilated choroidal vasculature and other features in indocyanine green angiography (ICGA) consistent with the diagnosis of CSC.\n\nExclusion Criteria:\n\n* any previous treatment for CSC;\n* evidence of choroidal neovascularization or other maculopathy on fundus examination.'}, 'identificationModule': {'nctId': 'NCT02799992', 'briefTitle': 'Pseudo-PDT in Central Serous Chorioretinopathy', 'organization': {'class': 'OTHER', 'fullName': 'Università degli Studi di Brescia'}, 'orgStudyIdInfo': {'id': 'CSC0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Half Dose Photodynamic Therapy', 'description': 'Half Dose Photodynamic Therapy The safety enhanced PDT protocol for CSC was performed using half the normal dose of verteporfin (Visudyne, Novartis Pharma, Switzerland), which is 3 mg/m2 verteporfin', 'interventionNames': ['Procedure: Half Dose Photodynamic Therapy']}, {'type': 'EXPERIMENTAL', 'label': '689 nm Laser Treatment', 'description': 'A 689 nm laser treatment delivering 95 J/cm2 by application of an intensity of 805 mW/cm2 over 118 seconds was performed. No verteporfin or other drugs were administered to the patients.', 'interventionNames': ['Procedure: 689 nm Laser Treatment of the Macula']}], 'interventions': [{'name': '689 nm Laser Treatment of the Macula', 'type': 'PROCEDURE', 'armGroupLabels': ['689 nm Laser Treatment']}, {'name': 'Half Dose Photodynamic Therapy', 'type': 'PROCEDURE', 'armGroupLabels': ['Half Dose Photodynamic Therapy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Andrea Russo, MD, PhD', 'role': 'CONTACT', 'email': 'dott.andrea.russo@gmail.com', 'phone': '+390303995308'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Università degli Studi di Brescia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD Candidate', 'investigatorFullName': 'Andrea Russo', 'investigatorAffiliation': 'Università degli Studi di Brescia'}}}}