Pseudo-PDT in Central Serous Chorioretinopathy

Not Applicable

• Conditions: Chronic Central Serous Chorioretinopathy
• Interventions: Procedure: 689 nm Laser Treatment of the Macula; Procedure: Half Dose Photodynamic Therapy

• Registration Number: NCT02799992
• Lead Sponsor: Università degli Studi di Brescia

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-06
• Study Start: 2016-06
• Study First Submitted: 2016-06-06
• Study First Submitted QC: 2016-06-09
• Last Update Submitted: 2016-06-09
• Study First Posted: 2016-06-15
• Last Update Posted: 2016-06-15
• Primary Completion: 2016-09
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 22

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
689 nm Laser Treatment	689 nm Laser Treatment of the Macula	A 689 nm laser treatment delivering 95 J/cm2 by application of an intensity of 805 mW/cm2 over 118 seconds was performed. No verteporfin or other drugs were administered to the patients.
Half Dose Photodynamic Therapy	Half Dose Photodynamic Therapy	Half Dose Photodynamic Therapy The safety enhanced PDT protocol for CSC was performed using half the normal dose of verteporfin (Visudyne, Novartis Pharma, Switzerland), which is 3 mg/m2 verteporfin

Primary Outcome Measures

Name	Time	Method
Central Retinal Thickness (micron)	6 months	Measured with OCT
Subfoveal Choroidal Thickness (micron)	6 months	Measured with OCT
Best-corrected Visual Acuity (LogMAR)	6 months	Measured with ETDRS chart

Secondary Outcome Measures

Name	Time	Method
Ellipsoid Zone Recovery (integrity of IS/OS line)	6 months	As visible with OCT scans