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

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ClinicalTrials.gov Identifier: NCT04224831
Recruitment Status : Completed
First Posted : January 13, 2020
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Umut Arslan, Ankara Universitesi Teknokent

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.

Condition or disease Intervention/treatment Phase
Central Serous Chorioretinopathy Chronic Central Serous Chorioretinopathy Combination Product: Source of growth factors: autologous platelet-rich plasma (aPRP) + repetitive electromagnetic stimulation for iontophoresis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Treatment of Chronic Recalcitrant or Unresponsive Central Serous Chorioretinopathy Via Electromagnetic Stimulation And Platelet- Rich Plasma
Actual Study Start Date : December 1, 2018
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Before application

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

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.


Active Comparator: After application
The changes in SMT, CMT, DRCD, and BCVA before and after the interventions were compared.
Combination Product: Source of growth factors: autologous platelet-rich plasma (aPRP) + repetitive electromagnetic stimulation for iontophoresis

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.





Primary Outcome Measures :
  1. Sub-macular thickness [ Time Frame: Change from baseline sub-macular thickness at 1 months ]
    This was measured manually from the ellipsoid zone to the Bruch's membrane in where sub-macular fluid is the thickest.


Secondary Outcome Measures :
  1. Vessel densities of deep retinal capillary plexus [ Time Frame: Change from baseline vessel densities of deep retinal capillary plexus at 1 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04224831


Locations
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Turkey
Ankara University Biotechnology Institute
Ankara, Türkiye, Turkey, 06312
Sponsors and Collaborators
Ankara Universitesi Teknokent
Investigators
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Principal Investigator: Umut Arslan, MD Ankara Universitesi Teknokent
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Umut Arslan, Principle investigator, MD, Ankara Universitesi Teknokent
ClinicalTrials.gov Identifier: NCT04224831    
Other Study ID Numbers: 03.10.2018/02
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Umut Arslan, Ankara Universitesi Teknokent:
Central serous chorioretinopathy
Electromagnetic stimulation
Platelet rich plasma
Growth factors
Iontophoresis
Additional relevant MeSH terms:
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Central Serous Chorioretinopathy
Retinal Diseases
Eye Diseases
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action