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

Central Serous Chorioretinopathy Clinical Trial

Official title:

The Changes of Retinal and Choroidal Capillaries After Half-dose Photodynamic Therapy Measured by Angio- OCT in Eyes With Central Serous Chorioretinopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03692169
• Other study ID #: CSC-PDT-OCTA(ZOC)
• Status: Recruiting
• Start date: October 31, 2016
• Est. completion date: June 30, 2019

Study information

• Verified date: September 2018
• Source: Sun Yat-sen University
• Contact: Fabao Xu
• Phone: 15521250400
• Email: 517311823[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2019
• Est. primary completion date: October 10, 2018
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 -

Related Conditions & MeSH terms

• 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.

Locations

Country	Name	City	State
China	Fabao Xu	Guangzhou	Guangdong
China	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Jin Chen-jin

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of retinal capillaries after hd-PDT	The primary outcome measure is the OCTA-based changes in the retinal capillaries after hd-PDT	1 month, 3 month
Secondary	The proportion of eyes with complete absorption of subretinal fluid(SRF)	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)	1 month, 3 month
Secondary	Change of Best Corrected Visual Acuity(BCVA)	The outcome 3 measure is the EDTRS charts-based improvement of Best Corrected Visual Acuity	1 month, 3 month
Secondary	Changes of choroidal thickness after hd-PDT	The outcome 4 measure is the OCT-based thinning of choroidal thickness after hd-PDT	1 month, 3 month