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Central Serous ChorioretinopathyCSCRNCT04224831

Treatment of Chronic Central Serous Chorioretinopathy Via Electromagnetic Stimulation and Platelet- Rich Plasma

A study testing Source of growth factors: autologous platelet-rich plasma (aPRP) + repetitive electromagnetic stimulation for iontophoresis in people with Central Serous Chorioretinopathy and Chronic Central Serous Chorioretinopathy, 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

Purpose: To investigate the efficacy of combined use of retinal repetitive electromagnetic stimulation and subtenon autologous platelet-rich plasma in the treatment of recalcitrant or unresponsive chronic central serous chorioretinopathy. Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
Source of growth factors: autologous platelet-rich plasma (aPRP) + repetitive electromagnetic stimulation for iontophoresis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Dec 2018to 1 Jan 2020
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

  • The chronic CSCR cases included here meet one or more of the following criteria:
  • Complaints of recurrent symptoms lasting longer than 3 months;
  • Recalcitrant or unresponsive to all known current treatment modalities including PDT and MPL;
  • Typical B-scan SD-OCT findings of chronicity such as elongation of photoreceptor outer segments indicating chronic nature of sub-macular fluid and/or the presence of serous flat-irregular RPED and focal areas of thickened RPE that lie below the collection of SRF;
  • Widespread RPE/photoreceptor damage, RPE mottling and atrophy along with chronic submacular fluid;
  • Widespread multifocal areas of chronic serous retinal detachment and/or flat-irregular RPEDs in those eyes that effective and reliable laser application is impossible.

Who cannot join

  • Sub-threshold micro-pulse laser and/or photodynamic therapy applied in the last three months;
  • Chronic CSCR complicated with secondary CNV.

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

Official title: Treatment of Chronic Recalcitrant or Unresponsive Central Serous Chorioretinopathy Via Electromagnetic Stimulation And Platelet- Rich Plasma

Purpose: To investigate the efficacy of combined use of retinal repetitive electromagnetic stimulation and subtenon autologous platelet-rich plasma in the treatment of recalcitrant or unresponsive chronic central serous chorioretinopathy.

Read the detailed description

Central serous chorioretinopathy (CSCR) is a retinal disorder that is mostly unilateral, and predominantly affects young and middle-aged male patients who are otherwise healthy. It is characterized by leaking fluid through a dysfunctional retinal pigment epithelium (RPE) to submacular area resulting in serous neuroretinal detachment. The main risk factors for CSCR include emotional stress, systemic arterial hypertension, pregnancy, use of corticosteroids, and the presence of pachychoroid under the RPE layer.

Although several clinical presentations are described, two forms of CSCR can be distinguished: acute and chronic. Acute CSCR usually presents with sudden visual loss of central vision, disturbed color vision and dark adaptation, central or paracentral scotoma, metamorphopsia, and/or micropsia caused by the rapid accumulation of subretinal fluid (SRF). While spontaneous resolution is common and self-limiting with little or no residual damage in the acute variant, the chronic variant is usually progressive with persistence of SRF. Persistent serous detachment for more than 3 months can result in progressive photoreceptor (PR) compromise, which explains the worsening visual outcomes versus the acute form.

The chronic form of CSCR is characterized by diffuse multifocal irregular hyper-fluorescence seen on fluorescein angiography (FA) and indocyanine green angiography (ICGA) in addition to widespread RPE changes. B-scan optical coherence tompgraphy (OCT) shows elongated PR outer segments and a shallow heterogenous RPE detachment surrounded by subretinal fluid containing fibrin/fluorophore. Widespread diffuse RPE abnormalities including RPE atrophy, intraretinal fluid, and cystic retinal changes, retinal atrophy, subretinal fibrinous accumulation, subretinal fibrosis, and secondary choroidal neovascularization (CNV) are late complications that can lead to permanent visual loss.

The etiology of this disease remains incompletely understood with systemic associations and a complex pathogenesis that involves diffuse dysfunction of the RPE cells, the choroid, or both. Various treatment modalities have been used nowadays with varying success rates. These are selected according to the stage of the disease and diffusiveness and presence of CNV. Examples include acetazolamide, mineralocorticoid receptor antagonists, intravitreal anti-VEGF injections, photodynamic therapy (PDT), and subthreshold micropulse lasers (MPL). However, some of the CSCR cases are recalcitrant or unresponsive to currently available therapy modalities. The disease can be recurrent in 15-50% of cases or bilateral in approximately one-third of cases. Secondary CNV is an important vision-threatening complication of longstanding CSCR with an incidence ranging from 2% to 9%. Thus, new treatment options and approaches, addressing the complex nature of the etiopathogenesis are necessary in patients who would otherwise be disabled.

Platelets are anucleated cells containing many types of growth factors (GFs) such as epithelial growth factor (EGF), fibroblast growth factor (FGF), transforming growth factor (TGF), nerve growth factor (NGF), platelet-derived growth factor (PDGF), and insulin-like growth factor (IGF). These growth factors and their receptors are expressed in epithelial and endothelial cells and play a key role in tissue healing. EGF stimulates the proliferation and migration of epithelial cells. NGF is a neurotrophin that stimulates growth and survival of intraretinal glial cells, Müller's cells, and neurons; it can restore the function of injured neurons. NGF also plays a key role in the integrity and function of the both epithelial cells and nerve fibers. Autologous platelet-rich plasma (aPRP) that contains many GFs has been used to treat retinitis pigmentosa and deep retinal capillary ischemia with promising clinical functional and structural improvements.

Repetitive high frequency electromagnetic stimulation (rEMS) has shown promising potential in epithelization and wound healing. rEMS creates a stimulated focus in the tissue by increasing blood flow and platelets at the capillary level. rEMS can also change the growth factor balance and tyrosine kinase (Trk) receptor activities in damaged microenvironment. Electromagnetic stimulation along with growth factors has shown synergetic effects toward enhanced epithelial integrity and neural functions. With the addition of possible iontophoresis effects in the rEMS, the passage of the various active molecules can be augmented at the tissue level thereby increasing the widespread effect of the GFs in the damaged choroidal and outer retinal microenvironment. Indeed, the combined use of rEMS and aPRP in the treatment of the eyes with deep retinal capillary ischemia due to various etiologies has shown favorable results in otherwise untreatable cases.

The primary aim of this prospective clinical study is to present the utility and efficacy of rEMS together with subtenon aPRP as a new treatment modality in the treatment of chronic CSCR cases which were recalcitrant or unresponsive to the current gold standard treatments. The second aim of the study is to evaluate whether there is ischemic evidences in choriocapillaris and the outer retina as well as their changes with this novel combination therapy.

Being tested
Source of growth factors: autologous platelet-rich plasma (aPRP) + repetitive electromagnetic stimulation for iontophoresis
Keywords
Central serous chorioretinopathy, Electromagnetic stimulation, Platelet rich plasma, Growth factors, Iontophoresis
Medical subject headings
Central Serous Chorioretinopathy

What participants receive

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

  • Source of growth factors: autologous platelet-rich plasma (aPRP) + repetitive electromagnetic stimulation for iontophoresisCombination product

    Autologous platelet rich plasma is containing many types of growth factors (GFs) such as epithelial growth factor (EGF), fibroblast growth factor (FGF), transforming growth factor (TGF), nerve growth factor (NGF), platelet-derived growth factor (PDGF), and insulin-like growth factor (IGF).

    Repetitive high frequency electromagnetic stimulation (rEMS) creates a stimulated focus in the tissue by increasing blood flow and platelets at the capillary level. Electromagnetic stimulation along with growth factors has shown synergetic effects toward enhanced epithelial integrity and neural functions. With the addition of possible iontophoresis effects in the rEMS, the passage of the various active molecules can be augmented at the tissue level thereby increasing the widespread effect of the GFs in the damaged choroidal and outer retinal microenvironment.

Study groups in NCT04224831
Study groupRoleWhat they receive
Before applicationActive comparatorThe chronic CSCR cases included here meet one or more of the following criteria: * Complaints of recurrent symptoms lasting longer than 3 months; * Recalcitrant or unresponsive to all known current treatment modalities including PDT and MPL; * Typical B-scan SD-OCT findings of chronicity such as elongation of photoreceptor outer segments indicating chronic nature of sub-macular fluid and/or the presence of serous flat-irregular RPED and focal areas of thickened RPE that lie below the collection of SRF; * Widespread RPE/photoreceptor damage, RPE mottling and atrophy along with chronic submacular fluid; * Widespread multifocal areas of chronic serous retinal detachment and/or flat-irregular RPEDs in those eyes that effective and reliable laser application is impossible.
Receives: Combination Product: Source of growth factors: autologous platelet-rich plasma (aPRP) + repetitive electromagnetic stimulation for iontophoresis
After applicationActive comparatorThe changes in SMT, CMT, DRCD, and BCVA before and after the interventions were compared.
Receives: Combination Product: Source of growth factors: autologous platelet-rich plasma (aPRP) + repetitive electromagnetic stimulation for iontophoresis

What is being measured

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

  1. Sub-macular thickness

    This was measured manually from the ellipsoid zone to the Bruch's membrane in where sub-macular fluid is the thickest.

    Measured: Change from baseline sub-macular thickness at 1 months

Secondary outcomes (1)
  1. Vessel densities of deep retinal capillary plexus

    These 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 deep capillary plexus could be compared. The OCTA device automatically calculated and displayed the vessel density maps as follow-up sequences (angio retina multi-scan view) and trend analysis.

    Measured: Change from baseline vessel densities of deep retinal capillary plexus at 1 months

Timeline

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

  1. First posted13 Jan 2020
  2. Study start1 Dec 2018
  3. Primary completion30 Sep 2019
  4. Study completion1 Jan 2020

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
Non-randomised
Intervention model
Single group
Model description
Prospective, open label study; The cases resistant to all known conventional treatment methods were compared before and after the application. The control group cannot be formed because there are cases resistant to all treatment methods.
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04224831
Sponsor's protocol ID
03.10.2018/02
Acronym
CSCR
Status last verified
Jan 2020
First submitted
6 Jan 2020
Last updated
13 Jan 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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
  • Nicholson B, Noble J, Forooghian F, Meyerle C. Central serous chorioretinopathy: update on pathophysiology and treatment. Surv Ophthalmol. 2013 Mar-Apr;58(2):103-26. doi: 10.1016/j.survophthal.2012.07.004.

    PubMed 23410821
  • Manayath GJ, Ranjan R, Karandikar SS, Shah VS, Saravanan VR, Narendran V. Central serous chorioretinopathy: Current update on management. Oman J Ophthalmol. 2018 Sep-Dec;11(3):200-206. doi: 10.4103/ojo.OJO_29_2018.

    PubMed 30505108
  • Ross A, Ross AH, Mohamed Q. Review and update of central serous chorioretinopathy. Curr Opin Ophthalmol. 2011 May;22(3):166-73. doi: 10.1097/ICU.0b013e3283459826.

    PubMed 21427570
  • Gemenetzi M, De Salvo G, Lotery AJ. Central serous chorioretinopathy: an update on pathogenesis and treatment. Eye (Lond). 2010 Dec;24(12):1743-56. doi: 10.1038/eye.2010.130. Epub 2010 Oct 8.

    PubMed 20930852
  • 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
  • Arslan U, Ozmert E. Treatment of resistant chronic central serous chorioretinopathy via platelet-rich plasma with electromagnetic stimulation. Regen Med. 2020 Aug;15(8):2001-2014. doi: 10.2217/rme-2020-0056. Epub 2020 Oct 27.

    PubMed 33107400

Questions about this trial

What is this clinical trial studying?

A study testing Source of growth factors: autologous platelet-rich plasma (aPRP) + repetitive electromagnetic stimulation for iontophoresis in people with Central Serous Chorioretinopathy and Chronic Central Serous Chorioretinopathy, 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 6 inclusion and 2 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 13 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?

Sub-macular thickness (time frame: Change from baseline sub-macular thickness at 1 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 NCT04224831, which also lists 7 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 13 Jan 2020; AzTrials last refreshed its copy on 8 Nov 2026.

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