Back to resultsPseudo-PDT in Central Serous Chorioretinopathy
Primary Purpose
Chronic Central Serous Chorioretinopathy
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
689 nm Laser Treatment of the Macula
Half Dose Photodynamic Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Central Serous Chorioretinopathy
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Half Dose Photodynamic Therapy
689 nm Laser Treatment
Arm Description
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
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.
Outcomes
Primary Outcome Measures
Best-corrected Visual Acuity (LogMAR)
Measured with ETDRS chart
Central Retinal Thickness (micron)
Measured with OCT
Subfoveal Choroidal Thickness (micron)
Measured with OCT
Secondary Outcome Measures
Ellipsoid Zone Recovery (integrity of IS/OS line)
As visible with OCT scans
Full Information
NCT ID
NCT02799992
First Posted
June 6, 2016
Last Updated
June 9, 2016
Sponsor
Università degli Studi di Brescia
1. Study Identification
Unique Protocol Identification Number
NCT02799992
Brief Title
Pseudo-PDT in Central Serous Chorioretinopathy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università degli Studi di Brescia
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Central Serous Chorioretinopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Half Dose Photodynamic Therapy
Arm Type
Active Comparator
Arm Description
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
Arm Title
689 nm Laser Treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
689 nm Laser Treatment of the Macula
Intervention Type
Procedure
Intervention Name(s)
Half Dose Photodynamic Therapy
Primary Outcome Measure Information:
Title
Best-corrected Visual Acuity (LogMAR)
Description
Measured with ETDRS chart
Time Frame
6 months
Title
Central Retinal Thickness (micron)
Description
Measured with OCT
Time Frame
6 months
Title
Subfoveal Choroidal Thickness (micron)
Description
Measured with OCT
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Ellipsoid Zone Recovery (integrity of IS/OS line)
Description
As visible with OCT scans
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Russo, MD, PhD
Phone
+390303995308
Email
dott.andrea.russo@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Pseudo-PDT in Central Serous Chorioretinopathy
We'll reach out to this number within 24 hrs