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CompletedNCT04252534rEMSUpdated Feb 5, 2020

Management of Retinitis Pigmentosa Via Electromagnetic Stimulation and Platelet Rich Plasma

An interventional study of PRP combined Magnovision and PRP in Retinitis Pigmentosa, sponsored by Ankara Universitesi Teknokent. Completed. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-02-05.

Sponsored by Ankara Universitesi Teknokent · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Retinitis Pigmentosa

Keywords

  • Retinitis pigmentosa
  • Electromagnetic stimulation
  • Platelet rich plasma
  • Magnovision
  • Ellipsoid zone
03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • RP patients in any phenotype with vision over 50 letters

Exclusion criteria

Exclusion Criteria:

  • Media opacity and nystagmus presence to prevent EZW imaging in OCT
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Repetitive electromagnetic stimulation

    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.

    Combination Product: PRP combined Magnovision · Biological: PRP

  • Active comparator
    Platelet rich plasma

    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.

    Biological: PRP

  • No intervention
    Natural course

    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

  • Combination productPRP combined Magnovision

    The rEMS helmet is used to stimulate the retina and visual pathways. (MagnovisionTM) combined with subtenon platelet rich plasma injection

  • BiologicalPRP

    Fresh autologous platelet rich plasma, injected subtenon space.

05

What researchers measure

Primary outcomes

  1. Ellipsoid zone width (EZW)

    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

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 29546474 ↗
  • 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. PubMed 31385285 ↗
  • 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. PubMed 31931872 ↗
  • 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. PubMed 32303913 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT04252534
Lead sponsor
Ankara Universitesi Teknokent
Responsible party
Umut Arslan (Principle investigator, MD, Ankara Universitesi Teknokent) — Principal investigator
First posted
Feb 5, 2020
Start date
Jan 1, 2017
Primary completion
Dec 30, 2019
Completion
Dec 30, 2019
Last update
Feb 5, 2020

Study contacts

Umut Arslan, MD
principal investigator · Ankara Universitesi Teknokent

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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