Choroidal Blood Flow in Acute and Chronic Central Serous Chorioretinopathy

Recruiting

• Conditions: Central Serous Chorioretinopathy
• Interventions: Drug: Verteporfin

• Registration Number: NCT05589974
• Lead Sponsor: Helse Stavanger HF

Brief Summary

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.

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 Timeline

• Study First Submitted: 2022-09-20
• Study Start: 2022-10-01
• Study First Submitted QC: 2022-10-18
• Study First Posted: 2022-10-21
• Status Verified: 2023-11
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-18
• Primary Completion: 2025-12-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chronic	Verteporfin	Patients with chronic CSC, i.e. symptoms and SRF for more than 4 months.

Primary Outcome Measures

Name	Time	Method
Change in mean blur rate	6 months	Relative changes in choroidal blood flow
Change in pulse wave form analysis	6 months	Changes in the shapes of pulse curves

Secondary Outcome Measures

Name	Time	Method
Change in choroidal density	6 months	Changes in the tissue density
Change in choroidal thickness	6 months	Changes in the morphology of the choroid

Trial Locations

Locations (1)

Stavanger University Hospital, Department of Ophthalmology; 🇳🇴 Stavanger, Norway