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

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Brief Title

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

Official Title

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

Brief 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.
    

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.
    


Study Type

Interventional


Primary Outcome

Sub-macular thickness

Secondary Outcome

 Vessel densities of deep retinal capillary plexus

Condition

Central Serous Chorioretinopathy

Intervention

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

Study Arms / Comparison Groups

 Before application
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Combination Product

Estimated Enrollment

22

Start Date

December 1, 2018

Completion Date

January 1, 2020

Primary Completion Date

September 30, 2019

Eligibility Criteria

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  Sub-threshold micro-pulse laser and/or photodynamic therapy applied in the last three
             months;

          -  Chronic CSCR complicated with secondary CNV.
      

Gender

All

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

Umut Arslan, MD, , 

Location Countries

Turkey

Location Countries

Turkey

Administrative Informations


NCT ID

NCT04224831

Organization ID

03.10.2018/02


Responsible Party

Principal Investigator

Study Sponsor

Ankara Universitesi Teknokent


Study Sponsor

Umut Arslan, MD, Principal Investigator, Ankara Universitesi Teknokent


Verification Date

January 2020