Central Serous Chorioretinopathy Clinical Trial
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03497000 -
Effects of OCTA-guided PDT in Acute CSC
|
N/A | |
Recruiting |
NCT03692169 -
The Changes of Retinal Capillaries After Half-dose PDT Measured by OCTA in Eyes With CSC
|
||
Not yet recruiting |
NCT02215330 -
A Study of the Beneficial Effects of Eplerenone on Central Serous Chorioretinopathy
|
Phase 2/Phase 3 | |
Completed |
NCT01990677 -
Eplerenone for the Treatment of Central Serous Chorioretinopathy
|
N/A | |
Completed |
NCT01971190 -
Efficacy and Safety of Intravitreal Aflibercept Injection for Subacute Central Serous Chorioretinopathy
|
Phase 2 | |
Active, not recruiting |
NCT01710332 -
The Safety & Efficacy of Intravitreal Aflibercept Injection in Patients With Persistent Central Serous Chorioretinopathy
|
Phase 2 | |
Active, not recruiting |
NCT00403884 -
Selective RPE Laser Treatment (SRT) for Various Macular Diseases
|
N/A | |
Recruiting |
NCT05570591 -
Subthreshold Nanosecond Laser for Non-resolving Central Serous Chorioretinopathy
|
N/A | |
Recruiting |
NCT05589974 -
Choroidal Blood Flow in Acute and Chronic Central Serous Chorioretinopathy
|
||
Completed |
NCT05104138 -
Eplerenone Versus PDT: Comparative Study by OCTA
|
||
Terminated |
NCT01982383 -
Study on the Use of Micropulse Laser to Treat Central Serous Chorioretinopathy
|
N/A | |
Completed |
NCT01880788 -
Genetic Analysis of Chronic Central Serous Chorioretinopathy Masquerading as Neovascular AMD
|
N/A | |
Completed |
NCT01327170 -
Micropulse Diode Laser Treatment for Chronic Central Serous Chorioretinopathy
|
N/A | |
Completed |
NCT01019668 -
Central Serous Chorioretinopathy Treated by Modified Photodynamic Therapy
|
N/A | |
Recruiting |
NCT06346405 -
Central Serous Chorioretinopathy and Micropulse Laser Treatment
|
||
Recruiting |
NCT02141308 -
OCT in Rare Chorioretinal Diseases
|
||
Completed |
NCT01822561 -
Eplerenone for Central Serous Chorioretinopathy
|
Phase 2 | |
Completed |
NCT00802906 -
Bevacizumab Versus Micropulse in Central Serous Chorioretinopathy (CSC)
|
N/A | |
Withdrawn |
NCT05679180 -
Navigated Microsecond Laser for Chronic Central Serous Chorioretinopathy: MICROPULSE
|
N/A | |
Completed |
NCT05686421 -
Comfortable and Stabilizing Chin & Forehead Rest Attachment for Slit Lamp Configurations
|
N/A |