Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 7:52 PM
Study NCT ID:
NCT07492966
Status:
COMPLETED
Last Update Posted:
2026-03-25
First Post:
2026-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exosomes Effect on Visual Function in CVI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019575', 'term': 'Blindness, Cortical'}], 'ancestors': [{'id': 'D001766', 'term': 'Blindness'}, {'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2025-09-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-20', 'studyFirstSubmitDate': '2026-02-08', 'studyFirstSubmitQcDate': '2026-03-20', 'lastUpdatePostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exploratory Objectives (Neuroplasticity Mechanisms)', 'timeFrame': 'Up to 1 year', 'description': 'Learning-curve slope analysis during rehabilitation tasks'}], 'primaryOutcomes': [{'measure': 'Whether exosome therapy combined with standardized neuro-visual rehabilitation improves functional vision outcomes compared to rehabilitation plus placebo.', 'timeFrame': 'Up to 1 year', 'description': 'Change in Visual Function Index (VFI) total score\n\nThe total score for visual function is 15, comprising the sum of 13 functions, each worth 1 point, and fixation, which is worth 2 points. Missing functions are scored as 0.'}, {'measure': 'Primary Objective ( Safety)', 'timeFrame': 'Up to 1 year', 'description': 'To evaluate the advers effects of repeated intranasal exosome administration in pediatric patients with CVI over a 12-week treatment period.\n\nEpileptic attack Allergic reactions Treatment discontinuation due to adverse events'}, {'measure': 'Affected Visual fields (Totally impaired /delayed)', 'timeFrame': 'Up to 1 year', 'description': 'Impaired Visual Field Before, n (%) 0/1'}], 'secondaryOutcomes': [{'measure': 'Exploratory Objectives (Neuroplasticity Mechanisms)', 'timeFrame': 'Up to 1 year', 'description': 'Quantification of "Delayed Field → Functional Field" transition rate'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cortical Visual Impairment', 'Visual Function', 'Nasal Mesenchymal Exosome', 'Exosome'], 'conditions': ['Cortical Visual Impairment', 'Visual Function']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.cureus.com/articles/64479-current-modalities-for-low-vision-rehabilitation.pdf', 'label': 'Current Modalities for Low Vision Rehabilitation'}, {'url': 'https://hal.science/hal-04948043v1/file/2022-Biomedicines-review.pdf', 'label': 'Recent Advances in Extracellular Vesicle-Based Therapies Using Induced Pluripotent Stem Cell-Derived Mesenchymal Stromal Cells'}, {'url': 'https://studenttheses.uu.nl/bitstream/handle/20.500.12932/41663/Writing%20Assignment_EVs%20application%20in%20ophthalmic%20diseases_ID.pdf?sequence=1', 'label': 'Extracellular vesicle-based therapy application and efficacy in ophthalmic diseases: from origin to target'}, {'url': 'https://www.frontiersin.org/journals/immunology/articles/10.3389/fimmu.2023.1097456/pdf', 'label': 'Extracellular vesicles as a new horizon in the diagnosis and treatment of inflammatory eye diseases: A narrative review of the literature'}, {'url': 'https://doi.org/10.1186/s13287-022-03234-y', 'label': 'Safety and efficacy outcomes after intranasal administration of neural stem cells in cerebral palsy: a randomized phase 1/2 controlled trial'}, {'url': 'http://166.62.7.99/conferences/LNMLS/BEHDP%202021/Y0611.pdf', 'label': 'Mesenchymal stem cell-derived exosomes therapy: research progress and mechanism of action'}, {'url': 'https://doi.org/10.1038/s41390-025-03856-x', 'label': 'Updates on neonatal cell and novel therapeutics: Proceedings of the Second Neonatal Cell Therapies Symposium (2024)'}, {'url': 'https://doi.org/10.1186/s13052-024-01679-w', 'label': 'Successful treatment of cortical visual impairment in children using anti-amblyopia treatment despite the absence of amblyopia: a case report'}, {'url': 'https://doi.org/10.3389/fcell.2022.809686', 'label': 'Possible Effect of the use of Mesenchymal Stromal Cells in the Treatment of Autism Spectrum Disorders: A Review'}, {'url': 'https://doi.org/10.32948/ajsep.2024.09.12', 'label': 'Research progress of stem cell therapy for neurological diseases'}, {'url': 'http://studytexter.com/wp-content/uploads/formidable/2/s40135-017-0153-0.pdf', 'label': 'Extracellular Vesicles: Biomarkers, Therapeutics, and Vehicles in the Visual System'}, {'url': 'https://doi.org/10.21203/rs.3.rs-3953405/v1', 'label': 'Exosomes derived from microRNA-22-3p-overexpressed mesenchymal stem cells protect retinal ganglion cells by regulating MAPK pathway'}, {'url': 'https://doi.org/10.1016/j.biopha.2024.116321', 'label': 'Human amniotic mesenchymal stromal cell-derived exosomes promote neuronal function by inhibiting excessive apoptosis in a hypoxia/ischemia-induced cerebral palsy model: A preclinical study'}]}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn about the effects of nazally applied exosome treatment on visual functions in children with Phase 1 Cerebral visual impairment (CVİ).\n\nThe main question it aims to answer is:\n\nDoes exosome therapy administered via the nasal route for neurological disorders in children with Phase 1 CVI also show a beneficial effect on visual functions? Researchers will compare visual and visual function findings before and after the exosome application to determine whether the exosome application is also effective in visual function.\n\nParticipants:\n\n* They will receive exosomes via the nasal route every month for 6 months.\n* They will visit the clinic every month for monitoring and tests.', 'detailedDescription': 'Purpose Cortical visual impairment (CVI) denotes a pediatric visual deficit arising from non-ocular etiologies, purportedly linked to perturbations in visual cortical processing regions. This syndrome characteristically ensues from perinatal insults-such as asphyxia, prematurity, neonatal hypoglycemia, or hypoxia-inflicting damage upon retro-geniculate visual pathways and cortical centers. Empirical evidence underscores cerebral neuroplasticity, facilitating reorganization despite congenital retro-geniculate lesions; nonetheless, CVI manifests heterogeneous visual and cognitive sequelae. With 17% of neonates necessitating intensive care, advancements in neonatal care have augmented survival, concomitantly escalating the prevalence of neurodevelopmental disorders including CVI and cerebral palsy (CP), thereby spurring investigational reparative modalities such as stem cell and molecular therapeutics.\n\nMethods This investigation prospectively enrolled 32 children aged 0.6-13 years diagnosed with CVI, who received intranasal exosome therapy (5 × 10\\^6 particles/dose) between 2023 and 2024. Administration occurred in 4-6 iterations at monthly intervals. Comprehensive neuro-ophthalmic evaluations encompassed dynamic retinoscopy, preferential looking assessments (LEA and Cardiff cards) for visual acuity and Visual Function Index, alongside surveillance of ventral stream deficits (e.g., delayed gaze, complexity aversion) and dorsal stream impairments (e.g., visuomotor orienting). Statistical analyses employed IBM SPSS Statistics version 25.0 (IBM Corp., Armonk, NY, USA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '34 Months', 'minimumAge': '12 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consisted of pediatric patients aged 12-34 months who dere diagnosed with Phase 1 CVI and SP and who were referred to the Zatay Pediatric Neurology Clinic. All participants recieved exosome therapy 4-6 times over a 12 month period, administered monthly.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Phase I Cerebral Palsy and Cortical Visual Impairment\n* During the 12 months period recieved 4-6 times intranasal exosome\n\nExclusion Criteria:\n\n* Irregular follow-up\n* Abondened the study'}, 'identificationModule': {'nctId': 'NCT07492966', 'briefTitle': 'Exosomes Effect on Visual Function in CVI', 'organization': {'class': 'OTHER', 'fullName': 'Okan University'}, 'officialTitle': 'The Effect of Nasal Mesenchymal Exosome Administration on Vision Function in CVI', 'orgStudyIdInfo': {'id': '2025/12-05'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'study group', 'description': 'The cohort comprised 32 pediatric volunteers aged 12-34 months diagnosed with Phase 1 cortical visual impairment (CVI) concomitant with simultaneous perception (SP) deficit at Zatay Paediatric Neurology Clinic between June 2024 and July 2025. All participants underwent intranasal exosome therapy administered in 4-6 monthly doses over a 12-month surveillance interval.\n\nData were prospectively accrued via clinical files and serial neuro-ophthalmic examination records, with comprehensive follow-up spanning 12 months to delineate therapeutic trajectory and neuroplastic adaptations.', 'interventionNames': ['Other: Molecularly matched therapy']}], 'interventions': [{'name': 'Molecularly matched therapy', 'type': 'OTHER', 'description': 'Derived from mesenchymal stem cells, exosomes are nano-scale vesicles characterized by their regenerative and anti-inflammatory capabilities. These vesicles can traverse the blood-brain barrier to transport functional cargo, including lipids, mRNA, and proteins, to target cells. Over the course of 12 months, volunteers were administered 5 million units of exosomes in 7 ml via nasal spray once a month for a total of 4-6 doses, with an infusion rate of 1 ml per hour.', 'armGroupLabels': ['study group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'state': 'Tuzla', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Okan University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'ipdSharing': 'YES', 'description': 'All IPD that underlie results in a publication', 'accessCriteria': 'Open access for academics'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hatice Semrin Timlioglu İper', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Hatice Semrin Timlioglu İper', 'investigatorAffiliation': 'Okan University'}}}}