Retinitis PigmentosarEMSNCT04252534
Management of Retinitis Pigmentosa Via Electromagnetic Stimulation and Platelet Rich Plasma
A study testing PRP combined Magnovision and PRP in people with Retinitis Pigmentosa, run by Ankara Universitesi Teknokent.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Retinitis Pigmentosa
- What is being tested?
- PRP combined Magnovision and PRP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- RP patients in any phenotype with vision over 50 letters
Who cannot join
- Media opacity and nystagmus presence to prevent EZW imaging in OCT
About this study
Official title: Management of Retinitis Pigmentosa Via Repetitive Electromagnetic Stimulation and Autologous Platelet Rich Plasma
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.
- Conditions
- Retinitis Pigmentosa
- Being tested
- PRP combined Magnovision, PRP
- Keywords
- Retinitis pigmentosa, Electromagnetic stimulation, Platelet rich plasma, Magnovision, Ellipsoid zone
- Medical subject headings
- Retinitis Pigmentosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP combined MagnovisionCombination product
The rEMS helmet is used to stimulate the retina and visual pathways. (MagnovisionTM) combined with subtenon platelet rich plasma injection
PRPBiological
Fresh autologous platelet rich plasma, injected subtenon space.
| Study group | Role | What they receive |
|---|---|---|
| Repetitive electromagnetic stimulation | Active comparator | 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. Receives: Combination Product: PRP combined Magnovision; Biological: PRP |
| Platelet rich plasma | Active comparator | 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. Receives: Biological: PRP |
| Natural course | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ellipsoid zone width (EZW)
The ellipsoid zone (EZ) is an image of the inner and outer segments of photoreceptor cells on OCT view
Measured: Change from baseline EZW at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Jan 2017
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Retinitis PigmentosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Comparative, open label
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Universitesi Teknokent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Umut Arslan, Ankara Universitesi Teknokent
- Investigators
- Umut Arslan, MD, Principal investigator, Ankara Universitesi Teknokent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252534
- Sponsor's protocol ID
- 19-1293-18
- Acronym
- rEMS
- Status last verified
- Feb 2020
- First submitted
- 31 Jan 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 29546474Ozmert 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 31385285Ozmert 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 31931872Arslan 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Retinitis Pigmentosa Via Repetitive Electromagnetic Stimulation and Autologous Platelet Rich Plasma
- ClinicalTrials.gov ID
- NCT04252534
- Acronym / sponsor ID
- rEMS / 19-1293-18
- Conditions
- Retinitis Pigmentosa
- Keywords
- Retinitis pigmentosa, Electromagnetic stimulation, Platelet rich plasma, Magnovision, Ellipsoid zone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ankara Universitesi TeknokentUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Comparative, open label
| Arm | Type | Receives |
|---|---|---|
| Repetitive electromagnetic stimulation | Active comparator | Combination Product: PRP combined Magnovision, Biological: PRPGroup 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. |
| Platelet rich plasma | Active comparator | Biological: PRPGroup 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. |
| Natural course | No intervention | –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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- RP patients in any phenotype with vision over 50 letters
Key exclusion criteria (1 listed)
- Media opacity and nystagmus presence to prevent EZW imaging in OCT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRP combined MagnovisionThe rEMS helmet is used to stimulate the retina and visual pathways. (MagnovisionTM) combined with subtenon platelet rich plasma injection | Combination product | Repetitive electromagnetic stimulation |
| PRPFresh autologous platelet rich plasma, injected subtenon space. | Biological | Platelet rich plasma, Repetitive electromagnetic stimulation |
Primary outcome
Ellipsoid zone width (EZW)
Time frame: Change from baseline EZW at 12 months
The ellipsoid zone (EZ) is an image of the inner and outer segments of photoreceptor cells on OCT view
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Background: PubMed 29546474Arslan 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.
- Background: PubMed 31385285Ozmert 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.
- Background: PubMed 31931872Ozmert 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.
- Derived from this study: PubMed 32303913Arslan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Umut Arslan, MD principal investigator
Ankara Universitesi Teknokent
Questions about this trial
What is this clinical trial studying?
A study testing PRP combined Magnovision and PRP in people with Retinitis Pigmentosa, run by Ankara Universitesi Teknokent.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ellipsoid zone width (EZW) (time frame: Change from baseline EZW at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04252534, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.