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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
Sponsor:
Information provided by (Responsible Party):
Andrea Russo, Università degli Studi di Brescia

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2016
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016

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Arms and Interventions
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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
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Primary Outcome Measures :
  1. Best-corrected Visual Acuity (LogMAR) [ Time Frame: 6 months ]
    Measured with ETDRS chart

  2. Central Retinal Thickness (micron) [ Time Frame: 6 months ]
    Measured with OCT

  3. Subfoveal Choroidal Thickness (micron) [ Time Frame: 6 months ]
    Measured with OCT


Secondary Outcome Measures :
  1. Ellipsoid Zone Recovery (integrity of IS/OS line) [ Time Frame: 6 months ]
    As visible with OCT scans


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02799992


Contacts
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Contact: Andrea Russo, MD, PhD +390303995308 dott.andrea.russo@gmail.com

Sponsors and Collaborators
Università degli Studi di Brescia
More Information
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Responsible Party: Andrea Russo, MD, PhD Candidate, Università degli Studi di Brescia
ClinicalTrials.gov Identifier: NCT02799992    
Other Study ID Numbers: CSC0001
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: June 15, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Central Serous Chorioretinopathy
Retinal Diseases
Eye Diseases