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The Safe Effective Light Dose of Photodynamic Therapy for Chronic Central Serous Chorioretinopathy

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ClinicalTrials.gov Identifier: NCT01630863
Recruitment Status : Unknown
Verified February 2015 by Min Sagong, Yeungnam University College of Medicine.
Recruitment status was:  Recruiting
First Posted : June 28, 2012
Last Update Posted : February 16, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To find the safe effective lowest light dose for photodynamic therapy (PDT). in the treatment of central serous chorioretinopathy.

Condition or disease Intervention/treatment
Central Serous Chorioretinopathy Procedure: Photodynamic therapy

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Safe Effective Light Dose of Photodynamic Therapy for Chronic Central Serous Chorioretinopathy
Study Start Date : June 2012
Primary Completion Date : October 2014
Estimated Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 50% group
power of PDT is applied to the patients at 50% of the full energy based on TAP study.
Procedure: Photodynamic therapy
Photodynamic therapy is performed using verteporfin. Full dose of verteporfin is infused for 10 minutes, followed by laser delivery at 15 minutes from the start of infusion. Different light dose of PDT is applied to the patients at 50%, 40% and 30% of the full energy based on TAP study. The area of irradiation is set to the abnormal choroidal vascular hyperpermeability on ICGA corresponding to the leaking area on FA.
Experimental: 40% group
Decreasing power of PDT is applied to the patients at 40% of the full energy based on TAP study.
Procedure: Photodynamic therapy
Photodynamic therapy is performed using verteporfin. Full dose of verteporfin is infused for 10 minutes, followed by laser delivery at 15 minutes from the start of infusion. Different light dose of PDT is applied to the patients at 50%, 40% and 30% of the full energy based on TAP study. The area of irradiation is set to the abnormal choroidal vascular hyperpermeability on ICGA corresponding to the leaking area on FA.
Experimental: 30% group
Decreasing power of PDT is applied to the patients at 30% of the full energy based on TAP study.
Procedure: Photodynamic therapy
Photodynamic therapy is performed using verteporfin. Full dose of verteporfin is infused for 10 minutes, followed by laser delivery at 15 minutes from the start of infusion. Different light dose of PDT is applied to the patients at 50%, 40% and 30% of the full energy based on TAP study. The area of irradiation is set to the abnormal choroidal vascular hyperpermeability on ICGA corresponding to the leaking area on FA.


Outcome Measures

Primary Outcome Measures :
  1. Changes of best corrected visual acuity [ Time Frame: 6 month ]
    Changes of best corrected visual acuity at baseline and 1, 3, 6 month after PDT


Secondary Outcome Measures :
  1. Change of central retinal thickness, success rate, recurrence rate, and complications [ Time Frame: 6 months ]
    Change of the central retinal thickness on optical coherence tomography (OCT)are compared at baseline at 1, 3, and 6 months after PDT. Additionally, success rate, recurrence rate, and complications between three groups are evaluated during 6 months.


Eligibility Criteria

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Idiopathic detachment of the neurosensory retina with a focal leak at the level of the RPE with FA
  2. Presence of SRF and/or serous pigment epithelial detachment on optical coherence tomography (OCT)
  3. Presence of abnormal dilated choroidal vasculature in ICGA
  4. Patients with symptomatic CSC of at least 3 months duration

Exclusion Criteria:

  1. Patients who received any previous treatment, including PDT or focal thermal laser photocoagulation for CSC, or who had evidence of CNV, PCV, or other maculopathy on clinical examination, FA, or ICGA
  2. Patients receiving exogenous corticosteroid treatment
  3. Patients with systemic diseases such as Cushing's disease or renal diseases
  4. Pregnant patients
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): NCT01630863


Contacts
Contact: Min Sagong 82-53-620-4191 msagong@ynu.ac.kr

Locations
Korea, Republic of
Yeungnam University College of Medicine Recruiting
Daegu, Korea, Republic of
Contact: Min Sagong    82-53-620-4191    msagong@ynu.ac.kr   
Principal Investigator: Min Sagong         
Sponsors and Collaborators
Yeungnam University College of Medicine
More Information

Responsible Party: Min Sagong, Assistant Professor, Yeungnam University College of Medicine
ClinicalTrials.gov Identifier: NCT01630863     History of Changes
Other Study ID Numbers: YUH-12-007-D4
First Posted: June 28, 2012    Key Record Dates
Last Update Posted: February 16, 2015
Last Verified: February 2015

Keywords provided by Min Sagong, Yeungnam University College of Medicine:
Central serous chorioretinopathy
photodynamic therapy
safe and effective dose

Additional relevant MeSH terms:
Central Serous Chorioretinopathy
Retinal Diseases
Eye Diseases