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Management of Retinitis Pigmentosa Via Electromagnetic Stimulation and Platelet Rich Plasma (rEMS)

Primary Purpose

Retinitis Pigmentosa

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PRP combined Magnovision
PRP
Sponsored by
Ankara Universitesi Teknokent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinitis Pigmentosa focused on measuring Retinitis pigmentosa, Electromagnetic stimulation, Platelet rich plasma, Magnovision, Ellipsoid zone

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • RP patients in any phenotype with vision over 50 letters

Exclusion Criteria:

  • Media opacity and nystagmus presence to prevent EZW imaging in OCT

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    No Intervention

    Arm Label

    Repetitive electromagnetic stimulation

    Platelet rich plasma

    Natural course

    Arm 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.

    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.

    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

    Outcomes

    Primary Outcome Measures

    Ellipsoid zone width (EZW)
    The ellipsoid zone (EZ) is an image of the inner and outer segments of photoreceptor cells on OCT view

    Secondary Outcome Measures

    Full Information

    First Posted
    January 31, 2020
    Last Updated
    February 1, 2020
    Sponsor
    Ankara Universitesi Teknokent
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04252534
    Brief Title
    Management of Retinitis Pigmentosa Via Electromagnetic Stimulation and Platelet Rich Plasma
    Acronym
    rEMS
    Official Title
    Management of Retinitis Pigmentosa Via Repetitive Electromagnetic Stimulation and Autologous Platelet Rich Plasma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2017 (Actual)
    Primary Completion Date
    December 30, 2019 (Actual)
    Study Completion Date
    December 30, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ankara Universitesi Teknokent

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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. Platelet-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. Repetitive 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Retinitis Pigmentosa
    Keywords
    Retinitis pigmentosa, Electromagnetic stimulation, Platelet rich plasma, Magnovision, Ellipsoid zone

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Comparative, open label
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Repetitive electromagnetic stimulation
    Arm Type
    Active Comparator
    Arm 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.
    Arm Title
    Platelet rich plasma
    Arm Type
    Active Comparator
    Arm 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.
    Arm Title
    Natural course
    Arm Type
    No Intervention
    Arm 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
    Intervention Type
    Combination Product
    Intervention Name(s)
    PRP combined Magnovision
    Intervention Description
    The rEMS helmet is used to stimulate the retina and visual pathways. (MagnovisionTM) combined with subtenon platelet rich plasma injection
    Intervention Type
    Biological
    Intervention Name(s)
    PRP
    Intervention Description
    Fresh autologous platelet rich plasma, injected subtenon space.
    Primary Outcome Measure Information:
    Title
    Ellipsoid zone width (EZW)
    Description
    The ellipsoid zone (EZ) is an image of the inner and outer segments of photoreceptor cells on OCT view
    Time Frame
    Change from baseline EZW at 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: RP patients in any phenotype with vision over 50 letters Exclusion Criteria: Media opacity and nystagmus presence to prevent EZW imaging in OCT
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Umut Arslan, MD
    Organizational Affiliation
    Ankara Universitesi Teknokent
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29546474
    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.
    Results Reference
    background
    PubMed Identifier
    31385285
    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.
    Results Reference
    background
    PubMed Identifier
    31931872
    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.
    Results Reference
    background
    PubMed Identifier
    32303913
    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.
    Results Reference
    derived

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    Management of Retinitis Pigmentosa Via Electromagnetic Stimulation and Platelet Rich Plasma

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