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

September 28, 2018 updated by: Jin Chen-jin

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

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).

Study Overview

Status

Unknown

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

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Zhongshan Ophthalmic Center, Sun Yat-sen University
      • Guangzhou, Guangdong, China, 510000
        • Completed
        • Fabao Xu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Central Serous Chorioretinopathy (CSC)

Description

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 -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 month, 3 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1 month, 3 month
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
1 month, 3 month
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
1 month, 3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 31, 2016

Primary Completion (ANTICIPATED)

October 10, 2018

Study Completion (ANTICIPATED)

June 30, 2019

Study Registration Dates

First Submitted

September 26, 2018

First Submitted That Met QC Criteria

September 28, 2018

First Posted (ACTUAL)

October 2, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 2, 2018

Last Update Submitted That Met QC Criteria

September 28, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • CSC-PDT-OCTA(ZOC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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