Pseudo-PDT in Central Serous Chorioretinopathy

Chronic Central Serous Chorioretinopathy Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02799992
• Other study ID #: CSC0001
• Status: Not yet recruiting
• Phase: N/A
• First received: June 6, 2016
• Last updated: June 9, 2016
• Start date: June 2016
• Est. completion date: September 2016

Study information

• Verified date: June 2016
• Source: Università degli Studi di Brescia
• Contact: Andrea Russo, MD, PhD
• Phone: +390303995308
• Email: dott.andrea.russo[@]gmail.com
• Is FDA regulated: No
• Health authority: Ethics Committee: Italy
• Study type: Interventional

Clinical Trial Summary

Acute central serous chorioretinopathy (CSC) is a common disorder in middle-aged patients, characterized by serous retinal detachment in the macular region. We evaluated half-dose verteporfin photodynamic therapy (hd-PDT) versus 689 nm laser treatment in chronic CSC.

Twenty-two eyes of 22 patients with symptomatic chronic CSC were randomized in a 1:1 ratio to receive hd-PDT (group 1) or 689-LT delivering 95 J/cm2 by application of an intensity of 805 mW/cm2 over 118 seconds. Best-corrected visual acuity (BCVA) and spectral-domain optical coherence tomography findings were compared between groups.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age =18 years;

• patients with best-corrected visual acuity (BCVA) of 20/200 or better;

• presence of subretinal fluid (SRF) and/or serous pigment epithelial detachment involving the fovea on optical coherence tomography (OCT);

• presence of active angiographic leakage in fluorescein angiography caused by CSC and no other diseases, and abnormal dilated choroidal vasculature and other features in indocyanine green angiography (ICGA) consistent with the diagnosis of CSC.

Exclusion Criteria:

• any previous treatment for CSC;

• evidence of choroidal neovascularization or other maculopathy on fundus examination.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Central Serous Chorioretinopathy
• Chronic Central Serous Chorioretinopathy

Intervention

Procedure:
• 689 nm Laser Treatment of the Macula

• Half Dose Photodynamic Therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Brescia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best-corrected Visual Acuity (LogMAR)	Measured with ETDRS chart	6 months	No
Primary	Central Retinal Thickness (micron)	Measured with OCT	6 months	No
Primary	Subfoveal Choroidal Thickness (micron)	Measured with OCT	6 months	No
Secondary	Ellipsoid Zone Recovery (integrity of IS/OS line)	As visible with OCT scans	6 months	Yes