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).
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
- Conditions the study is for
- Central Serous Chorioretinopathy, Chronic Central Serous Chorioretinopathy
- 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
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. 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.
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)
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.
- First posted13 Jan 2020
- Study start1 Dec 2018
- Primary completion30 Sep 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Central Serous ChorioretinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ankara Universitesi Teknokent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Umut Arslan, Ankara Universitesi Teknokent
- Investigators
- Umut Arslan, MD, Principal investigator, Ankara Universitesi Teknokent
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 31385285Nicholson 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 23410821Manayath 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 30505108Ross 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 21427570Gemenetzi 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 20930852Arslan 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 29546474Arslan 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Chronic Recalcitrant or Unresponsive Central Serous Chorioretinopathy Via Electromagnetic Stimulation And Platelet- Rich Plasma
- ClinicalTrials.gov ID
- NCT04224831
- Acronym / sponsor ID
- CSCR / 03.10.2018/02
- Keywords
- Central serous chorioretinopathy, Electromagnetic stimulation, Platelet rich plasma, Growth factors, Iontophoresis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Ankara Universitesi TeknokentUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Before application | Active comparator | Combination Product: Source of growth factors: autologous platelet-rich plasma (aPRP) + repetitive electromagnetic stimulation for iontophoresisThe 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. |
| After application | Active comparator | Combination Product: Source of growth factors: autologous platelet-rich plasma (aPRP) + repetitive electromagnetic stimulation for iontophoresisThe changes in SMT, CMT, DRCD, and BCVA before and after the interventions were compared. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- The chronic CSCR cases included here meet one or more of the following criteria:
Key exclusion criteria (2 listed)
- Sub-threshold micro-pulse laser and/or photodynamic therapy applied in the last three months;
- Chronic CSCR complicated with secondary CNV.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Source of growth factors: autologous platelet-rich plasma (aPRP) + repetitive electromagnetic stimulation for iontophoresisAutologous 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. | Combination product | After application, Before application |
Primary outcome
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.
1 secondary outcome
Vessel densities of deep retinal capillary plexus
Time frame: Change from baseline vessel densities of deep retinal capillary plexus at 1 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Background: PubMed 31385285Ozmert 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.
- Results publication: PubMed 23410821Nicholson 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.
- Results publication: PubMed 30505108Manayath 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.
- Results publication: PubMed 21427570Ross 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.
- Results publication: PubMed 20930852Gemenetzi 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.
- Results publication: PubMed 29546474Arslan 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.
- Derived from this study: PubMed 33107400Arslan 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.
- Individual participant dataSharing planned: No
Related trials for Central Serous Chorioretinopathy
Not yet recruitingObservational study
A Case-Control Study Revealing Intraocular Microenvironment Characteristics in Patients With Ocular Diseases Based on Multi-Omics Analysis
Age- Related Macular Degeneration, Diabetic Retinopathy
Not yet recruiting
Mindfulness for Central Serous Chorioretinopathy
Central Serous Chorioretinopathy
RecruitingObservational study
Biomarkers and Choroidal Neovascularization
Choroidal Neovascularization, Mineralocorticoid Excess
Not yet recruitingPhase 2
Faricimab for Chronic Central Serous Chorioretinopathy: A Randomized Sham-Controlled Trial
Central Serous Chorioretinopathy (CSC)
Recruiting
the Study of the Association Between the Gut Microbiota and Central Serous Chorioretinopathy
Central Serous Chorioretinopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Umut Arslan, MD principal investigator
Ankara Universitesi Teknokent
1 site in 1 country: see every site and its status.
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.