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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

Tracking Information
First Submitted Date September 26, 2018
First Posted Date October 2, 2018
Last Update Posted Date October 2, 2018
Actual Study Start Date October 31, 2016
Estimated Primary Completion Date October 10, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 28, 2018)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: September 28, 2018)
  • 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)
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Changes of Retinal Capillaries After Half-dose PDT Measured by OCTA in Eyes With CSC
Official Title The Changes of Retinal and Choroidal Capillaries After Half-dose Photodynamic Therapy Measured by Angio- OCT in Eyes With Central Serous Chorioretinopathy
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).
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with Central Serous Chorioretinopathy (CSC)
Condition Central Serous Chorioretinopathy
Intervention 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.
Study Groups/Cohorts 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.
Intervention: Procedure: Half-dose photodynamic therapy
Publications * Peng J, Zhong L, Ma L, Jin J, Zheng Y, Jin C. Comparison of vascular parameters between normal cynomolgus macaques and healthy humans by optical coherence tomography angiography. BMC Ophthalmol. 2019 Oct 11;19(1):204. doi: 10.1186/s12886-019-1207-x.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 28, 2018)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2019
Estimated Primary Completion Date October 10, 2018   (Final data collection date for primary outcome measure)
Eligibility 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 -
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Fabao Xu 15521250400 517311823@qq.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03692169
Other Study ID Numbers CSC-PDT-OCTA(ZOC)
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Jin Chen-jin, Sun Yat-sen University
Study Sponsor Jin Chen-jin
Collaborators Not Provided
Investigators
Study Director: Chenjin Jin Zhongshan Ophthalmic Center, Sun Yat-sen University
PRS Account Sun Yat-sen University
Verification Date September 2018