Choroidal Blood Flow in Acute and Chronic Central Serous Chorioretinopathy

Patients with central serous chorioretinopathy (CSC) will be monitored with laser speckle flow graphy (LSFG), swept source optical coherence tomography (SS-OCT) and SS-OCT angiography (SS-OCTA). The aim is to unveil the flow and pulse wave characteristics of the choroidal circulation in acute CSC and chronic CSC.

Study Overview

• Status: Recruiting
• Conditions: Central Serous Chorioretinopathy
• Intervention / Treatment: Drug: Verteporfin

Detailed Description

Acute CSC - The proposed study tests the hypothesis that choroidal blood flow characteristics are related to the eventual resolution of subretinal fluid. Such relation can shed light on pathophysiological disease mechanisms and constitute a biomarker for disease activity.

Chronic CSC - The proposed study tests the hypothesis that choroidal blood flow characteristics will change in response to standard treatment with PDT. The research of such changes will increase the understanding of the treatment response. This knowledge will help in the effort to understand the why some patients are non-responsive to the treatment.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Vegard Forsaa, MD PhD; Phone Number: +4748152212; Email: forsaa@gmail.com

Study Locations

• Norway
  • Stavanger, Norway, 4016
    • Recruiting
    • Stavanger University Hospital, Department of Ophthalmology
    • Contact: Vegard Forsaa, MD; Phone Number: +47 48152212; Email: vegard.forsaa@sus.no
    • Principal Investigator: Vegard Forsaa, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with acute or chronic CSC.

Description

Inclusion Criteria:-

• Able to sign informed consent
• Possible to obtain fundus imaging

• Acute CSC ˂4 months of duration in one eye, defined as:

  1. Subfoveal presence of SRF on OCT
  2. Present attack is 1st -3rd attack of CSC

  b) Patient history and examination consistent with acute CSC c) Characteristic appearance of acute CSC on fundus autofluorescence (FAF) and OCT

• Chronic CSC ≥4 months of duration in one eye, defined as:

  1. Subfoveal presence of SRF on OCT
  2. Subjective visual loss/symptoms
  3. Characteristic appearance of chronic CSC on FAF, fluorescein angiography (FA), and indocyanin angiography (ICGA) and OCT
  4. Patient history and examination consistent with chronic CSC

Exclusion Criteria:

• History of retinal disease other than CSC (e.g. retinal detachment)
• Contraindications for FA, ICGA or PDT (only for chronic CSC)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Acute; Patients with acute first attack CSC with subretinal fluid (SRF) on OCT and symptom duration under 4 months.
Chronic; Patients with chronic CSC, i.e. symptoms and SRF for more than 4 months.	Drug: Verteporfin; Chronic CSC are receiving one treatment before the observation period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mean blur rate	Relative changes in choroidal blood flow	6 months
Change in pulse wave form analysis	Changes in the shapes of pulse curves	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in choroidal density	Changes in the tissue density	6 months
Change in choroidal thickness	Changes in the morphology of the choroid	6 months

Collaborators and Investigators

• Sponsor: Helse Stavanger HF
• Investigators: Principal Investigator: Vegard Forsaa, MD PhD, Helse Stavanger HF

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: September 20, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Central Serous Chorioretinopathy; Photosensitizing Agents; Dermatologic Agents; Verteporfin
• Other Study ID Numbers: REK485079

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: This study can be expanded as a multicenterstudy. I so, IPD will be shared among the study group.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No