Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 1:19 PM
Study NCT ID:
NCT07427160
Status:
RECRUITING
Last Update Posted:
2026-02-23
First Post:
2026-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognostic Role of Macular Neovascular Membrane Subtype in Pneumatic Displacement of Macular Hemorrhages
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-17', 'studyFirstSubmitDate': '2026-02-17', 'studyFirstSubmitQcDate': '2026-02-17', 'lastUpdatePostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anatomical success rate of pneumatic displacement', 'timeFrame': '5-8 days post-treatment', 'description': 'Percentage of patients achieving successful subretinal hemorrhage displacement, defined as the absence of subretinal blood within the internal ring of the ETDRS grid (3 mm centered on the fovea) at the first post-operative OCT'}, {'measure': 'Change in Best-Corrected Visual Acuity (BCVA)', 'timeFrame': 'Baseline and 6 months.', 'description': 'Evaluation of the difference in visual acuity from baseline to the 6-month follow-up. Snellen chart measurements will be converted to LogMAR for statistical analysis.'}], 'secondaryOutcomes': [{'measure': 'Change in Central Retinal Thickness', 'timeFrame': 'Baseline, 1 month, 3 months, and 6 months.', 'description': 'Measurement of retinal thickness (in microns) using Spectralis HRA+OCT to evaluate the anatomical response to treatment.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['AMD - Age-Related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'This study investigates the prognostic value of macular neovascularization (MNV) subtypes in patients treated with pneumatic displacement for submacular hemorrhage. The researchers will compare anatomical and functional outcomes (visual acuity) between PCV, RAP, and other MNV forms within a Caucasian cohort to identify subtype-specific predictors of recovery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of Caucasian patients, aged 50 years or older, diagnosed with submacular hemorrhage (SMH) secondary to macular neovascularization (MNV). All participants underwent pneumatic displacement treatment at the Multizonal Ophthalmology Unit of the Provincial Agency for Healthcare Services (APSS) in Trento and Rovereto, Italy, between December 1, 2016, and May 31, 2023.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing pneumatic displacement (PD) for submacular hemorrhage (SMH), secondary to macular neovascularization (MNV)\n* Age 50 years or older at the time of SMH diagnosis\n* Caucasian ethnicity\n* SMH involving the central or internal ring of the Early Treatment Diabetic Retinopathy Study (ETDRS) grid (within a 3 mm circumference centered on the fovea)\n* SMH dimensions equal to or greater than one papillary diameter\n* Pneumatic displacement treatment performed within 36 hours of SMH diagnosis\n\nExclusion Criteria:\n\n* SMH estimated to be present for more than 15 days at the time of diagnosis\n* SMH secondary to conditions other than MNV\n* Presence of proliferative diabetic retinopathy in the study eye\n* Aphakia in the study eye\n* Inadequate pupillary dilation, media opacities, or other impediments to retinal imaging\n* Previous pneumatic displacement procedures for SMH in the study eye\n* Ocular surgery in the 8 weeks preceding the pneumatic displacement intervention\n* Follow-up duration of less than 6 months following the procedure'}, 'identificationModule': {'nctId': 'NCT07427160', 'briefTitle': 'Prognostic Role of Macular Neovascular Membrane Subtype in Pneumatic Displacement of Macular Hemorrhages', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Sanitaria Universitaria Integrata del Trentino'}, 'officialTitle': 'Prognostic Role of Macular Neovascular Membrane Subtype in Pneumatic Displacement of Macular Hemorrhages', 'orgStudyIdInfo': {'id': 'GAS.MNV'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PCV', 'description': 'Patients with submacular hemorrhage secondary to Polypoidal Choroidal Vasculopathy (PCV)'}, {'label': 'RAP', 'description': 'Patients with submacular hemorrhage secondary to Retinal Angiomatous Proliferation (RAP), also known as Type 3 MNV'}, {'label': 'Other MNV', 'description': 'Patients with submacular hemorrhage secondary to other forms of Macular Neovascularization (MNV) not classified as PCV or RAP'}]}, 'contactsLocationsModule': {'locations': [{'zip': '38122', 'city': 'Trento', 'state': 'Trento', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'marco mazzola, MD', 'role': 'CONTACT', 'email': 'marco.mazzola@asuit.tn.it', 'phone': '+39479950266'}, {'name': 'tommaso brighenti, MD', 'role': 'CONTACT', 'email': 'tommaso.brighenti@asuit.tn.it', 'phoneExt': '+39348780821'}, {'name': 'marco mazzola, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale Santa Chiara Di Trento', 'geoPoint': {'lat': 46.06787, 'lon': 11.12108}}], 'centralContacts': [{'name': 'marco mazzola, medical doctor', 'role': 'CONTACT', 'email': 'marco.mazzola@asuit.tn.it', 'phone': '+393479950266'}, {'name': 'tommaso brighenti, MD', 'role': 'CONTACT', 'email': 'tommaso.brighenti@asuit.tn.it', 'phone': '+393484780821'}], 'overallOfficials': [{'name': 'marco mazzola, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Azienda Sanitaria Universitaria Integrata del Trentino'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marco Mazzola', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MEDICAL DOCTOR', 'investigatorFullName': 'Marco Mazzola', 'investigatorAffiliation': 'Azienda Sanitaria Universitaria Integrata del Trentino'}}}}