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Deep Retinal Capillary IschemiarEMSNCT04242719

Management of Deep Retinal Capillary Ischemia by Electromagnetic Stimulation and Platelet- Rich Plasma

A study testing Electromagnetic stimulation and Platelet rich plasma in people with Deep Retinal Capillary Ischemia and Paracentral Acute Middle Maculopathy, run by Ankara Universitesi Teknokent at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To investigate the efficacy of retinal electromagnetic stimulation and sub-tenon autologous platelet rich plasma in the treatment of deep retinal capillary ischemia. Read more about this study

Who is it for?
Ages 15 to 80 years
What is being tested?
Electromagnetic stimulation and Platelet rich plasma
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2018to 28 Feb 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 15 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients complaining of blurred vision and/or acute-onset paracentral scotoma during the last month without any visible fundus change along with typical SD-OCT and OCTA findings.

Who cannot join

  • The presence of noticeable changes in the fundus examination,
  • Any optic media opacity that may cause artefacts on OCTA images and interfere with quantitative measurements of the DCP vessel density,
  • Complaining of paracentral scotoma lasting more than 1 month (in order to exclude chronic changes in the retinal tissue),
  • Presence of atrophic changes in INL or ONL on cross-sectional B-scan SD-OCT

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ankara University Biotechnology Institute

    Ankara, Türkiye, 06312

Other trials in Turkey (Türkiye)

About this study

To investigate the efficacy of retinal electromagnetic stimulation and sub-tenon autologous platelet rich plasma in the treatment of deep retinal capillary ischemia.

Read the detailed description

Deep retinal capillary ischemia (DRCI) is a recently described entity in patients presenting with an acute-onset paracentral scotoma. Subclinical macular lesions of DRCI were formerly best visualized on near-infrared reflectance imaging. The development of optical coherence tomography angiography (OCTA) has facilitated studies of the retinal capillary structures. The multiplanar superficial capillary plexus is located in the inner plexiform layer (IPL) and contains synapses between bipolar and ganglion cells as well as amacrine cells. The deep capillary plexus (DCP) is located in the outer plexiform layer (OPL), which is thinner than the IPL. The DCP is composed of synapses of photoreceptors, bipolar cells, and horizontal cells. This area is also at the border of the oxygen diffusion from the choroid. It is likely that the oxygen coming from the choroid has been completely consumed by the photoreceptors because of the low partial pressure of oxygen level in the outer nuclear layer (ONL). The DCP supplies both the bipolar cells and the synaptic structure of the OPL and Henle fibers.

Deep retinal capillary ischemia is an ischemic event in the middle and deep layers of the retina due to various systemic or local vascular pathologies. It is obvious in the intraretinal hyper-reflective bandlike zone located superior or inferior to the OPL conjointly on in a structural cross-sectional B-scan of the spectral domain optical coherence tomography (SD-OCT) examination along with an acute-onset paracentral scotoma and subjective complaints of the patient. Ophthalmologists often face a significant diagnostic challenge because of a lack of noticeable changes in the appearance of the retina.

DRCI has two different appearances on B-scan SD-OCT exams according to the level of the involved DCP. If the hyper-reflective bandlike zone is located on the outer plexiform layer-inner nuclear layer (OPL-INL) junction, then it is termed "Paracentral Acute Middle Maculopathy (PAMM)" or type-1 deep retinal capillary ischemia. If the hyper-reflective band is seen on the OPL-ONL junction, then it is termed as type-2 deep retinal capillary ischemia. This might be a new variant of "Acute Macular Neuroretinopathy (AMN)". These intraretinal hyperreflective zones are seen as patchy areas of various patterns on en-face OCT image, and atrophic areas in the inner and the outer nuclear layer respectively are developed in the late stage of the diseases. The pathophysiologic features of DCP ischemia is considered to be ischemic hypoxia leading to cell death with swelling of the middle retinal tissues. This may lead to severe vision loss and permanent paracentral scotoma depending on the underlying cause and depth of ischemia. It can also be observed by slowing metabolic activity in photoreceptors and neural retina. The metabolic slowdown is defined as a dormant phase in photoreceptors and OFF mode in the neural retina.

The retinal deep capillary plexus is a single monoplanar capillary plexus located in the OPL. It has the lowest vessel density-this is a significant finding that might be used to evaluate retinal vascular diseases accurately. For this reason, the changes in the percentage of the vessel density in DCP during the follow-up were preferred as an assessment parameter of the treatment modalities used in this prospective clinical study.

Platelets are anucleated cells that contain many types of growth factors including platelet-derived growth factor(PDGF), transforming growth factor-β(TGF-β), vascular endothelial growth factor(VEGF), and epidermal growth factor(EGF) in alpha granules. Thus, the supplementation of growth medium with autologous platelet-rich plasma (aPRP) could be desirable for clinical applications and could lead to some functional improvement.

High-frequency repetitive electromagnetic stimulation (rEMS) has promising therapeutic potential in ischemic neurological patients. The rationale of rEMS is that it modulates neural excitability and increases neural plasticity; thus, it improves the functional outcome. These neuroprotective effects of rEMS are dependent on the increase in the level of brain-derived neurotrophic factor (BDNF), VEGF, and increased tyrosine kinase A, B, and C (TrkA, TrkB, and TrkC) receptor activation. Therefore, high-frequency rEMS might be a promising therapeutic strategy for ischemic retinal disorders such as DRCI.

There is no known and proven specific treatment for DRCI to date except for systemic check-ups and treatment of the underlying diseases or predisposing factors. The aim of this preliminary clinical study is to investigate the efficacy of high-frequency rEMS alone or in combination with sub-tenon fresh aPRP as a treatment modality in the treatment of DRCI. To the best of our knowledge, this is the first prospective clinical trial on this subject in the ophthalmic literature.

Being tested
Electromagnetic stimulation, Platelet rich plasma
Keywords
Deep retinal capillary ischemia, Paracentral acute middle maculopathy, Acute macular neuroretinopathy, Electromagnetic stimulation, Magnovision, Platelet-rich plasma
Medical subject headings
White Dot Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electromagnetic stimulationDevice

    Also called Magnovision

    Retinal electromagnetic stimulation A high-frequency repetitive electromagnetic stimulation protocol has been defined in the literature and was applied in groups 1 and group 2 via a novel device developed specifically for ophthalmic usage (Magnovision-TM, Bioretina Biyoteknoloji AŞ, Ankara,Turkey). The patients underwent 10 consecutive sessions of rEMS application. Parameters for the treatment were 42 hertz frequency/min, 30 minutes of duration and mild operating cycle. The power of the electromagnetic field was 2000 milligauss, which is a very low dose and within the safety limits of World Health Organisation. In group 2, sub-tenon aPRP injections were also performed immediately after the first, fifth, and tenth sessions of rEMS application.

  • Platelet rich plasmaBiological

    Also called Autologous PRP

    About 20 ml of blood was drawn from the patient's antecubital vein and inserted into two 10-ml vacutainer tubes that contain trisodium citrate (T-LAB PRP Kit, T-Biyoteknoloji, Bursa, TURKEY). These tubes were placed in a refrigerated (+4 °C) centrifuge (Nüve NF 1200R, Nüve Laboratuar Teknolojileri, Ankara, TURKEY) and spun at 2500 rpm (580×g) for 8 min within 30 min of collection. Three different layers formed in the tubes: red blood cells at the bottom, platelet-rich plasma in the middle, and platelet-poor plasma in the top layer. A total of 1.5 ml of the middle layer (which mainly contained platelets) was withdrawn by syringe and immediately injected into the sub-tenon space of each eye after topical anesthesia with proparacaine hydrochloride (Alcaine, Alcon, USA) drops.

Study groups in NCT04242719
Study groupRoleWhat they receive
Only electromagnetic stimulationActive comparatorOnly rEMS was preferred as the initial step
Receives: Device: Electromagnetic stimulation
Combined with electromagnetic stimulation and PRPActive comparatorOrder to augment the effect of the rEMS, sub-tenon aPRP injection was added.
Receives: Device: Electromagnetic stimulation; Biological: Platelet rich plasma
Natural courseNo interventionServed as control group, and existing systemic disorder(s) were consulted and treated accordingly.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Deep retinal capillary vessel density

    The vessel densities (in %) of deep capillary plexus were measured with "AngioAnalytic" feature of the OCTA device. To compare the percentage of the vessel densities precisely during follow-up, the "Link-B Scans" button on the screen was activated so that the exact same segmentation planes of the DCP could be compared. The OCTA device automatically calculated and displayed the vessel density maps as follow-up sequences (Angio Retina multiscan view) and trend analysis.

    Measured: Change from baseline deep reinal capillary vessel density at 1 month.

  2. Best corrected visual acuity

    Number of readable letters after glasses correction

    Measured: Change from baseline best corrected visual acuity at 1 month.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2020
  2. Study start1 Jan 2018
  3. Primary completion30 Jan 2019
  4. Study completion28 Feb 2019

Resources

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
Randomised
Intervention model
Parallel groups
Model description
Prospective, open-label, comparative
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04242719
Sponsor's protocol ID
17-1177-18
Acronym
rEMS
Status last verified
Jan 2020
First submitted
20 Jan 2020
Last updated
27 Jan 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nemiroff J, Kuehlewein L, Rahimy E, Tsui I, Doshi R, Gaudric A, Gorin MB, Sadda S, Sarraf D. Assessing Deep Retinal Capillary Ischemia in Paracentral Acute Middle Maculopathy by Optical Coherence Tomography Angiography. Am J Ophthalmol. 2016 Feb;162:121-132.e1. doi: 10.1016/j.ajo.2015.10.026. Epub 2015 Nov 10.

    PubMed 26562176
  • 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
  • Luo J, Zheng H, Zhang L, Zhang Q, Li L, Pei Z, Hu X. High-Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) Improves Functional Recovery by Enhancing Neurogenesis and Activating BDNF/TrkB Signaling in Ischemic Rats. Int J Mol Sci. 2017 Feb 20;18(2):455. doi: 10.3390/ijms18020455.

    PubMed 28230741
  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Electromagnetic stimulation and Platelet rich plasma in people with Deep Retinal Capillary Ischemia and Paracentral Acute Middle Maculopathy, run by Ankara Universitesi Teknokent at 1 site in Turkey (Türkiye).

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 4 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 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Deep retinal capillary vessel density (time frame: Change from baseline deep reinal capillary vessel density at 1 month.). The study lists 2 primary outcomes in all. 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 NCT04242719, 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 27 Jan 2020.

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