Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-29 @ 1:19 PM
Study NCT ID:
NCT04252534
Status:
COMPLETED
Last Update Posted:
2020-02-05
First Post:
2020-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Management of Retinitis Pigmentosa Via Electromagnetic Stimulation and Platelet Rich Plasma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2020-08-14', 'releaseDate': '2020-08-02'}, {'resetDate': '2020-09-16', 'releaseDate': '2020-08-28'}, {'resetDate': '2020-10-09', 'releaseDate': '2020-09-17'}, {'resetDate': '2021-01-28', 'releaseDate': '2021-01-11'}, {'resetDate': '2023-03-16', 'releaseDate': '2023-03-14'}, {'resetDate': '2023-12-13', 'releaseDate': '2023-03-16'}], 'estimatedResultsFirstSubmitDate': '2020-08-02'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012174', 'term': 'Retinitis Pigmentosa'}], 'ancestors': [{'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D058499', 'term': 'Retinal Dystrophies'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Comparative, open label'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-01', 'studyFirstSubmitDate': '2020-01-31', 'studyFirstSubmitQcDate': '2020-01-31', 'lastUpdatePostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ellipsoid zone width (EZW)', 'timeFrame': 'Change from baseline EZW at 12 months', 'description': 'The ellipsoid zone (EZ) is an image of the inner and outer segments of photoreceptor cells on OCT view'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Retinitis pigmentosa', 'Electromagnetic stimulation', 'Platelet rich plasma', 'Magnovision', 'Ellipsoid zone'], 'conditions': ['Retinitis Pigmentosa']}, 'referencesModule': {'references': [{'pmid': '29546474', 'type': 'BACKGROUND', 'citation': 'Arslan U, Ozmert E, Demirel S, Ornek F, Sermet F. Effects of subtenon-injected autologous platelet-rich plasma on visual functions in eyes with retinitis pigmentosa: preliminary clinical results. Graefes Arch Clin Exp Ophthalmol. 2018 May;256(5):893-908. doi: 10.1007/s00417-018-3953-5. Epub 2018 Mar 15.'}, {'pmid': '31385285', 'type': 'BACKGROUND', 'citation': 'Ozmert E, Arslan U. Management of Deep Retinal Capillary Ischemia by Electromagnetic Stimulation and Platelet-Rich Plasma: Preliminary Clinical Results. Adv Ther. 2019 Sep;36(9):2273-2286. doi: 10.1007/s12325-019-01040-2. Epub 2019 Aug 5.'}, {'pmid': '31931872', 'type': 'BACKGROUND', 'citation': "Ozmert E, Arslan U. Management of retinitis pigmentosa by Wharton's jelly derived mesenchymal stem cells: preliminary clinical results. Stem Cell Res Ther. 2020 Jan 13;11(1):25. doi: 10.1186/s13287-020-1549-6."}, {'pmid': '32303913', 'type': 'DERIVED', 'citation': 'Arslan U, Ozmert E. Management of Retinitis Pigmentosa via Platelet-Rich Plasma or Combination with Electromagnetic Stimulation: Retrospective Analysis of 1-Year Results. Adv Ther. 2020 May;37(5):2390-2412. doi: 10.1007/s12325-020-01308-y. Epub 2020 Apr 18.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate whether natural progression rate can be slowed down with subtenon PRP or PRP application combined with rEMS in retinitis pigmentosa cases.', 'detailedDescription': 'Retinitis pigmentosa (RP) is a progressive external retinal degeneration resulting from mutation in any of the 260 genes found in the retinal pigment epithelium (RPE). The progression rate and findings of the disease are heterogeneous according to genetic mutation and heredity type. The initial symptom of the disease is usually night blindness (nyctalopia) beginning in childhood or adolescent period. Narrowing in the visual field and legal blindness develops as the disease progresses. If low grade inflammation is added, the disease is complicated by cataracts, epiretinal membrane and macular edema. In the fundus examination, the appearance of midperiferal bone spicule pigmentation is usually sufficient to diagnosis. Developments in optical coherence tomography (OCT) technology enable detailed imaging of the sensorial retina and the ellipsoid zone. The ellipsoid zone (EZ) is an image of the inner and outer segments of photoreceptor cells. Loss of EZ is considered the gold standard in the diagnosis and follow-up of RP. Visual field monitoring and electroretinography (ERG) are indirect signs of EZ loss and correlated with EZ width. Mutations in RPE disrupt the synthesis of some vital peptide and growth factors for photoreceptors.\n\nPlatelet-rich plasma (PRP) is a good source of growth factors. Platelets have more than 30 growth factors and cytokines in α-granules such as neurotrophic growth factor (NGF), neural factor (NF), brain derived neurotrophic factor (BDNF), basic fibroblast growth factor (bFGF), insulin-like growth factor (IGF), transforming growth factor (TGF-β), vascular endothelial growth factor (VEGF), platelet derived growth factor (PDGF) etc. These peptides regulate the energy cycle at the cellular level, local capillary blood flow, neurogenesis and cellular metabolism. Anti-inflammatory effects of PRP are also associated with soluble cytokines.\n\nRepetitive electromagnetic stimulation (rEMS), increases binding affinity and the synthesis of growth factor receptors on neural tissues. It provides electromagnetic iontophoresis by changing the electrical charges of tyrosine kinase receptors (Trk). rEMS forms hyperpolarization-depolarization waves in neurons, thereby increasing neurotransmission and capillary blood flow. Trk receptors are commonly found around limbus, extraocular muscle insertions and the optic nerve. Molecules smaller than 75 kD can pass from the sclera passively to the suprachoroidal space. Electrical or electromagnetic iontophoresis is required for molecules larger than 75kD such as BDNF and IGF to pass through the sclera.\n\nThe aim of this study is to investigate whether natural progression rate can be slowed down with subtenon PRP or PRP application combined with rEMS in retinitis pigmentosa cases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* RP patients in any phenotype with vision over 50 letters\n\nExclusion Criteria:\n\n* Media opacity and nystagmus presence to prevent EZW imaging in OCT'}, 'identificationModule': {'nctId': 'NCT04252534', 'acronym': 'rEMS', 'briefTitle': 'Management of Retinitis Pigmentosa Via Electromagnetic Stimulation and Platelet Rich Plasma', 'organization': {'class': 'OTHER', 'fullName': 'Ankara Universitesi Teknokent'}, 'officialTitle': 'Management of Retinitis Pigmentosa Via Repetitive Electromagnetic Stimulation and Autologous Platelet Rich Plasma', 'orgStudyIdInfo': {'id': '19-1293-18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Repetitive electromagnetic stimulation', 'description': 'Group 1 consists of 20 RP patients (40 eyes) who received combined rEMS with PRP. In this group, patients received rEMS for 30 minutes before subtenon PRP injections. In this group, 3 loading doses were applied at 3-week intervals. Then 2 booster dose were applied at 6-month intervals.', 'interventionNames': ['Combination Product: PRP combined Magnovision', 'Biological: PRP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Platelet rich plasma', 'description': 'Group 2 consists of 20 RP patients (40 eyes). In this group, patients received only subtenon PRP injections. In this group, 3 loading doses were applied at 3-week intervals. Then 2 booster dose were applied at 6-month intervals.', 'interventionNames': ['Biological: PRP']}, {'type': 'NO_INTERVENTION', 'label': 'Natural course', 'description': 'Group 3 consists of 20 RP patients (40 eyes). Patients in this group did not accept any interventional application and were only followed up. The'}], 'interventions': [{'name': 'PRP combined Magnovision', 'type': 'COMBINATION_PRODUCT', 'description': 'The rEMS helmet is used to stimulate the retina and visual pathways. (MagnovisionTM) combined with subtenon platelet rich plasma injection', 'armGroupLabels': ['Repetitive electromagnetic stimulation']}, {'name': 'PRP', 'type': 'BIOLOGICAL', 'description': 'Fresh autologous platelet rich plasma, injected subtenon space.', 'armGroupLabels': ['Platelet rich plasma', 'Repetitive electromagnetic stimulation']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Umut Arslan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara Universitesi Teknokent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara Universitesi Teknokent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator, MD', 'investigatorFullName': 'Umut Arslan', 'investigatorAffiliation': 'Ankara Universitesi Teknokent'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2020-08-02', 'type': 'RELEASE'}, {'date': '2020-08-14', 'type': 'RESET'}, {'date': '2020-08-28', 'type': 'RELEASE'}, {'date': '2020-09-16', 'type': 'RESET'}, {'date': '2020-09-17', 'type': 'RELEASE'}, {'date': '2020-10-09', 'type': 'RESET'}, {'date': '2021-01-11', 'type': 'RELEASE'}, {'date': '2021-01-28', 'type': 'RESET'}, {'date': '2023-03-14', 'type': 'RELEASE'}, {'date': '2023-03-16', 'type': 'RESET'}, {'date': '2023-03-16', 'type': 'RELEASE'}, {'date': '2023-12-13', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Umut Arslan, Principle investigator, MD, Ankara Universitesi Teknokent'}}}}