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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

Tracking Information
First Submitted Date  ICMJE June 6, 2016
First Posted Date  ICMJE June 15, 2016
Last Update Posted Date June 15, 2016
Study Start Date  ICMJE June 2016
Estimated Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2016)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2016)
Ellipsoid Zone Recovery (integrity of IS/OS line) [ Time Frame: 6 months ]
As visible with OCT scans
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pseudo-PDT in Central Serous Chorioretinopathy
Official Title  ICMJE Not Provided
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Central Serous Chorioretinopathy
Intervention  ICMJE
  • Procedure: 689 nm Laser Treatment of the Macula
  • Procedure: Half Dose Photodynamic Therapy
Study Arms  ICMJE
  • 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
    Intervention: 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.
    Intervention: Procedure: 689 nm Laser Treatment of the Macula
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 9, 2016)
22
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2016
Estimated Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02799992
Other Study ID Numbers  ICMJE CSC0001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andrea Russo, Università degli Studi di Brescia
Study Sponsor  ICMJE Università degli Studi di Brescia
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Università degli Studi di Brescia
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP