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The Changes of Retinal Capillaries After Half-dose PDT Measured by OCTA in Eyes With CSC

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ClinicalTrials.gov Identifier: NCT03692169
Recruitment Status : Recruiting
First Posted : October 2, 2018
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
Jin Chen-jin, Sun Yat-sen University

Brief Summary:
To determine changes in retinal and choroidal capillaries with optical coherence tomographic angiography (OCTA) after half-dose photodynamic therapy (hd-PDT) in eyes with central serous chorioretinopathy (CSC).

Condition or disease Intervention/treatment
Central Serous Chorioretinopathy Procedure: Half-dose photodynamic therapy

Detailed Description:

PDT was hypothesized to have a primary effect on the choroidal capillaries, and a number of studies have reported choriocapillary damage and choroidal vascular remodeling after PDT. More recently, although OCTA related CSC research has been conducted, no quantitative report has thoroughly investigated the microstructural changes in the superficial, deep retinal and choroidal capillaries after hd-PDT. The purpose of the present study is to determine the changes in the retinal and choroidal capillaries quantitatively with OCTA after hd-PDT in eyes with CSC.

This is a prospective observational study of patients undergoing hd-PDT for CSC with active leakage in retinal pigment epithelium (RPE) and followed for 3 months. Fundus fluorescein angiography (FFA) and indocyanine green angiography (ICGA) were performed at baseline; best corrected visual acuity (BCVA), fundus photography, optical coherence tomography angiography (OCTA) with the split-spectrum amplitude-decorrelation angiography algorithm (XR Optovue, Fremont, CA, USA) and spectral domain OCT (SD-OCT) were performed at baseline and each follow-up visit after hd-PDT.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Changes of Retinal and Choroidal Capillaries After Half-dose Photodynamic Therapy Measured by Angio- OCT in Eyes With Central Serous Chorioretinopathy
Actual Study Start Date : October 31, 2016
Estimated Primary Completion Date : October 10, 2018
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Verteporfin

Group/Cohort Intervention/treatment
CSC patients
Half-dose photodynamic therapy was performed when a serous retinal detachment involving the macular fovea was present; The treatment field size was set as 3000 microns. This was achieved by administering 3mg/m² of Verteporfin intravenously over a period of 10 minutes. Fifteen minutes after commencing the verteporfin infusion the GLD was exposed to a 689 nm laser light with a florescence of 600 mw/cm² for 83 seconds and a total energy of 50 J/cm². OCTA (XR Optovue, Fremont, CA, USA) and spectral domain OCT (SD-OCT) were performed at baseline and each follow-up (one month and three months) visit after hd-PDT.
Procedure: Half-dose photodynamic therapy
Half-dose photodynamic therapy was achieved by administering 3mg/m² of Verteporfin (Visudyne; Novartis, Switzerland) intravenously over a period of 10 minutes. Fifteen minutes after commencing the verteporfin infusion the greatest linear dimension was exposed to a 689 nm laser light with a florescence of 600 mw/cm² for 83 seconds and a total energy of 50 J/cm². Optical coherence tomography angiography (OCTA) with the split-spectrum amplitude-decorrelation angiography algorithm (XR Optovue, Fremont, CA, USA) and spectral domain OCT (SD-OCT) were performed at baseline and each follow-up (one month and three months) visit after hd-PDT.




Primary Outcome Measures :
  1. Changes of retinal capillaries after hd-PDT [ Time Frame: 1 month, 3 month ]
    The primary outcome measure is the OCTA-based changes in the retinal capillaries after hd-PDT


Secondary Outcome Measures :
  1. The proportion of eyes with complete absorption of subretinal fluid(SRF) [ Time Frame: 1 month, 3 month ]
    The outcome 2 measure is the OCT-based improvement rate (defined as the proportion of eyes with complete absorption of subretinal fluid on OCT images)

  2. Change of Best Corrected Visual Acuity(BCVA) [ Time Frame: 1 month, 3 month ]
    The outcome 3 measure is the EDTRS charts-based improvement of Best Corrected Visual Acuity

  3. Changes of choroidal thickness after hd-PDT [ Time Frame: 1 month, 3 month ]
    The outcome 4 measure is the OCT-based thinning of choroidal thickness after hd-PDT



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with Central Serous Chorioretinopathy (CSC)
Criteria

Inclusion Criteria:

  1. CSC diagnosed by FFA and ICGA, where the active leakage was just located in macular fovea with SRF confirmed by OCT
  2. Patient age ≥18 years
  3. BCVA ≥35 letters on ETDRS charts
  4. Persistent CSC for a period of time or patients were anxiety about the symptom and asking for treatment
  5. Lack of either spontaneous improvement or improvement induced by empirical treatment such as pharmaceutical drug
  6. The provision of written informed consent -

Exclusion Criteria:

  1. The presence of any other chorioretinal diseases that may affect the studies, such as age-related macular degeneration (AMD), polypoidal choroidal vasculopathy (PCV)
  2. Patients who had received any previous treatment, including PDT, intraocular drug injection or focal thermal laser photocoagulation for CSC
  3. Patients with PED in macular fovea which the average diameter (transverse diameter and vertical diameter) was more than 300 microns
  4. Patients with high myopia, defined as a refractive error (spherical equivalent) < -6.00 diopters, or an axial length >26.5 mm
  5. Patients with media opacities, or signal strength index of the images < 60
  6. Patients under corticosteroid therapy -

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): NCT03692169


Contacts
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Contact: Fabao Xu 15521250400 517311823@qq.com

Locations
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China, Guangdong
Fabao Xu Completed
Guangzhou, Guangdong, China, 510000
Zhongshan Ophthalmic Center, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510000
Sponsors and Collaborators
Jin Chen-jin
Investigators
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Study Director: Chenjin Jin Zhongshan Ophthalmic Center, Sun Yat-sen University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jin Chen-jin, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03692169    
Other Study ID Numbers: CSC-PDT-OCTA(ZOC)
First Posted: October 2, 2018    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Jin Chen-jin, Sun Yat-sen University:
Central serous chorioretinopathy
Additional relevant MeSH terms:
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Central Serous Chorioretinopathy
Retinal Diseases
Eye Diseases
Verteporfin
Photosensitizing Agents
Dermatologic Agents