Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-01-21 @ 10:50 PM
Study NCT ID:
NCT06346405
Status:
RECRUITING
Last Update Posted:
2025-09-23
First Post:
2024-03-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Central Serous Chorioretinopathy and Micropulse Laser Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056833', 'term': 'Central Serous Chorioretinopathy'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-17', 'studyFirstSubmitDate': '2024-03-05', 'studyFirstSubmitQcDate': '2024-03-28', 'lastUpdatePostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vessel density changes', 'timeFrame': '12 and 24 months', 'description': 'Evaluation of changes in vessel density of choriocapillaris by optical coherence tomography (OCT) angiography before and after treatment'}], 'secondaryOutcomes': [{'measure': 'Choroidal thickness', 'timeFrame': '12 and 24 months', 'description': 'Evaluation of changes in choroidal thickness before and after treatment.'}, {'measure': 'Choroidal thickness and vessel density', 'timeFrame': '12 and 24 months', 'description': 'Correlation among changes in choroidal thickness and changes in vessel density of choriocapillary with best corrected visual acuity.'}, {'measure': 'Qualitative analysis of retino-choroidal vascularization with identification of vascular pattern', 'timeFrame': '12 and 24 months', 'description': 'To qualitatively evaluate the vascular patterns using optical coherence tomography (OCT) - angiography and to verify if a particular one is associated with a greater response to subthreshold micropulse laser treatment.'}, {'measure': 'Metamorphopsia', 'timeFrame': '12 and 24 months', 'description': 'Evaluation of quantitative improvement of metamorphosia by M-CHARTS after treatment.'}, {'measure': 'Metamorphopsia and BCVA', 'timeFrame': '12 and 24 months', 'description': 'Correlation between metamorphopsia and best corrected visual acuity (BCVA)'}, {'measure': 'Ellipsoid Zone Integrity', 'timeFrame': '12 and 24 months', 'description': 'Evaluation of ellipsoid zone integrity by optical coherence tomography (OCT) B scan.'}, {'measure': 'Improvement in retinal function', 'timeFrame': '12 and 24 months', 'description': 'To evaluate the potential improvement in retinal function with mean retinal sensitivity and microperimetry.'}, {'measure': 'Quality of life (QoL)', 'timeFrame': '12 and 24 months', 'description': 'Evaluation of correlation among quality of life parameters assessed by visual function questionnaire (VFQ), stress and relapses and visual acuity.'}, {'measure': 'Ellipsoid zone and BCVA', 'timeFrame': '12 and 24 months', 'description': 'To evaluate the association between ellipsoid zone integrity on optical coherence tomography (OCT) B scan and best corrected visual acuity (BCVA)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Central Serous Chorioretinopathy']}, 'descriptionModule': {'briefSummary': 'To evaluate choroidal and choriocapillaris changes in patients with central serous chorioretinopathy, undergone sub threshold micropulse laser treatment, following any improvement with conservative therapy with Acetazolamide and/or Eplerenone'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients older than 18 years old, with diagnosis of central serous chorioretinopathy since at least 6 months, undergone Acetazolamide and/or Eplerenone therapy with no improvement after 6 months.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of central serous chorioretinopathy (CSC) with no response to conservative therapy, consisted in Acetazolamide and Eplerenone after six months.\n* Foveal serous retinal detachment for at least 6 months.\n* Minimum age of 18 years old at the screening time\n* Reading and comprehension skills of informed consent\n\nExclusion Criteria:\n\n* Previous retinal treatment for CSC, except for Acetazolamide and Eplerenone\n* No diffuse retinal epitheliopathy\n* Other concomitant ocular diseases, such as age related macular degeneration, diabetic retinopathy, choroidal neovascularization\n* Not controlled glaucoma with eyedrops, or advanced glaucoma\n* Myopia or hypermetropia greater than 6 diopters\n* Opacities of dioptric media\n* Low quality of optical coherence tomography (OCT) and OCT-Angiography scans\n* Low quality images of Fluorescein angiography and indocyanine green angiography\n* No written consensus signed.'}, 'identificationModule': {'nctId': 'NCT06346405', 'acronym': 'LEVEO', 'briefTitle': 'Central Serous Chorioretinopathy and Micropulse Laser Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Central Serous Chorioretinopathy and Micropulse Laser Treatment: Evaluation of Morphological and Functional Recovery', 'orgStudyIdInfo': {'id': '10'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Subthreshold Micropulse Laser Treatment', 'type': 'OTHER', 'description': 'Subthreshold micropulse laser treatment consists in 33 spots of 100 microns, distance among each spot of 2.50 microns, duration of 200 sec, power of 250 milliwatt (mW) duty cycle 5%.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Roma', 'state': 'R', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Maria Cristina Savastano, MD, PhD', 'role': 'CONTACT', 'email': 'mariacristinasavastano@policlinicogemelli.it', 'phone': '(+39)063015'}], 'facility': 'Fondazione Policlinico Agostino Gemelli, IRCCS', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'centralContacts': [{'name': 'Maria Cristina Savastano, MD, PhD', 'role': 'CONTACT', 'email': 'mariacristinasavastano@policlinicogemelli.it', 'phone': '(+39)063015'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Savastano Maria Cristina', 'investigatorAffiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}}}}