Choroidal Blood Flow in Acute and Chronic Central Serous Chorioretinopathy

Sponsor

Helse Stavanger HF (Other)

Overall Status

Recruiting

CT.gov ID

NCT05589974

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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). We aim to unveil the flow and pulse wave characteristics of the choroidal circulation in acute CSC and chronic CSC.

Condition or Disease	Intervention/Treatment	Phase
Central Serous Chorioretinopathy	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 Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Choroidal Blood Flow in Acute and Chronic Central Serous Chorioretinopathy

Actual Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Jul 31, 2026

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Choroidal blood flow1 [6 months]
Change in mean blur rate
Choroidal blood flow2 [6 months]
Change in pulse wave form analysis

Secondary Outcome Measures

Choroidal morphology [6 months]
Change in choroidal density
Choroidal morphology [6 months]
Change in choroidal thickness

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:-

Able to sign informed consent
Possible to obtain fundus imaging
Acute CSC ˂4 months of duration in one eye, defined as:

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

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:

Subfoveal presence of SRF on OCT
Subjective visual loss/symptoms
Characteristic appearance of chronic CSC on FAF, fluorescein angiography (FA), and indocyanin angiography (ICGA) and OCT
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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stavanger University Hospital, Department of Ophthalmology	Stavanger		Norway	4016

Sponsors and Collaborators

Helse Stavanger HF

Investigators

Principal Investigator: Vegard Forsaa, MD PhD, Helse Stavanger HF

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Helse Stavanger HF

ClinicalTrials.gov Identifier:

NCT05589974

Other Study ID Numbers:

REK485079

First Posted:

Oct 21, 2022

Last Update Posted:

Oct 21, 2022

Last Verified:

Sep 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Central Serous Chorioretinopathy

Verteporfin

Study Results

No Results Posted as of Oct 21, 2022