Pseudo-PDT in Central Serous Chorioretinopathy
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|ClinicalTrials.gov Identifier: NCT02799992|
Recruitment Status : Unknown
Verified June 2016 by Andrea Russo, Università degli Studi di Brescia.
Recruitment status was: Not yet recruiting
First Posted : June 15, 2016
Last Update Posted : June 15, 2016
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||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||September 2016|
|Estimated Study Completion Date :||September 2016|
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
- Best-corrected Visual Acuity (LogMAR) [ Time Frame: 6 months ]Measured with ETDRS chart
- Central Retinal Thickness (micron) [ Time Frame: 6 months ]Measured with OCT
- Subfoveal Choroidal Thickness (micron) [ Time Frame: 6 months ]Measured with OCT
- Ellipsoid Zone Recovery (integrity of IS/OS line) [ Time Frame: 6 months ]As visible with OCT scans
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02799992
|Contact: Andrea Russo, MD, PhDfirstname.lastname@example.org|