Pseudo-PDT in Central Serous Chorioretinopathy

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrea Russo, MD, PhD; Phone Number: +390303995308; Email: dott.andrea.russo@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Procedure: Half Dose Photodynamic Therapy
Experimental: 689 nm Laser Treatment; 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.	Procedure: 689 nm Laser Treatment of the Macula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best-corrected Visual Acuity (LogMAR)	Measured with ETDRS chart	6 months
Central Retinal Thickness (micron)	Measured with OCT	6 months
Subfoveal Choroidal Thickness (micron)	Measured with OCT	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ellipsoid Zone Recovery (integrity of IS/OS line)	As visible with OCT scans	6 months

Collaborators and Investigators

• Sponsor: Università degli Studi di Brescia

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): September 1, 2016
• Study Completion (Anticipated): September 1, 2016

Study Registration Dates

• First Submitted: June 6, 2016
• First Submitted That Met QC Criteria: June 9, 2016
• First Posted (Estimate): June 15, 2016

Study Record Updates

• Last Update Posted (Estimate): June 15, 2016
• Last Update Submitted That Met QC Criteria: June 9, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Central Serous Chorioretinopathy
• Other Study ID Numbers: CSC0001