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

NCT04224831 | Completed DMC

• 1 other identifier: 03.10.2018/02
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Serous Chorioretinopathy; Chronic Central Serous Chorioretinopathy

Keywords

Central serous chorioretinopathy; Electromagnetic stimulation; Platelet rich plasma; Growth factors; Iontophoresis

Outcome Measures

Primary Outcomes (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.

  Change from baseline sub-macular thickness at 1 months

Secondary Outcomes (1)

• Vessel densities of deep retinal capillary plexus

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

Study Arms (2)

Before application

ACTIVE COMPARATOR

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

After application

ACTIVE COMPARATOR

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

Interventions

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

After application; Before application

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ankara Universitesi Teknokent: lead

Study Sites (1)

Ankara University Biotechnology Institute

Ankara, Türkiye, 06312, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  PMID: 31385285 BACKGROUND

• 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.

  PMID: 23410821 RESULT

• 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.

  PMID: 30505108 RESULT

• 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.

  PMID: 21427570 RESULT

• 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.

  PMID: 20930852 RESULT

• 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.

  PMID: 29546474 RESULT

• 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.

  PMID: 33107400 DERIVED

MeSH Terms

Conditions

Central Serous Chorioretinopathy

Interventions

Iontophoresis

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Electrophoresis; Electrochemical Techniques; Investigative Techniques

Study Officials

• Umut Arslan, MD

  Ankara Universitesi Teknokent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator, MD

Model Details: 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.

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 13, 2020
• Study Start: December 1, 2018
• Primary Completion: September 30, 2019
• Study Completion: January 1, 2020
• Last Updated: January 13, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)