Skip to content

Management of Retinitis Pigmentosa Via Electromagnetic Stimulation and Platelet Rich Plasma

Management of Retinitis Pigmentosa Via Repetitive Electromagnetic Stimulation and Autologous Platelet Rich Plasma

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04252534
Acronym
rEMS
Enrollment
60
Registered
2020-02-05
Start date
2017-01-01
Completion date
2019-12-30
Last updated
2020-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinitis Pigmentosa

Keywords

Retinitis pigmentosa, Electromagnetic stimulation, Platelet rich plasma, Magnovision, Ellipsoid zone

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.

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.

Sponsors

Ankara Universitesi Teknokent
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Comparative, open label

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Ellipsoid zone width (EZW)Change from baseline EZW at 12 monthsThe ellipsoid zone (EZ) is an image of the inner and outer segments of photoreceptor cells on OCT view

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026