Pseudo-PDT in Central Serous Chorioretinopathy

• Sponsor: Università degli Studi di Brescia (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02799992
• Collaborator: (none)
• Enrollment: 22
• Arms: 2
• Duration (Months): 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Central Serous Chorioretinopathy	Procedure: 689 nm Laser Treatment of the Macula; Procedure: Half Dose Photodynamic Therapy	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Jun 1, 2016
• Anticipated Primary Completion Date: Sep 1, 2016
• Anticipated Study Completion Date: Sep 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Best-corrected Visual Acuity (LogMAR) [6 months]

   Measured with ETDRS chart

2. Central Retinal Thickness (micron) [6 months]

   Measured with OCT

3. Subfoveal Choroidal Thickness (micron) [6 months]

   Measured with OCT

Secondary Outcome Measures

1. Ellipsoid Zone Recovery (integrity of IS/OS line) [6 months]

   As visible with OCT scans

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Università degli Studi di Brescia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Andrea Russo, MD, PhD Candidate, Università degli Studi di Brescia
• ClinicalTrials.gov Identifier: NCT02799992
• Other Study ID Numbers: CSC0001
• First Posted: Jun 15, 2016
• Last Update Posted: Jun 15, 2016
• Last Verified: Jun 1, 2016

• Additional relevant MeSH terms: Central Serous Chorioretinopathy

Study Results

No Results Posted as of Jun 15, 2016