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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Yeungnam University College of Medicine
Sponsor:
Information provided by (Responsible Party):
Min Sagong, Yeungnam University College of Medicine
ClinicalTrials.gov Identifier:
NCT01630863
First received: June 26, 2012
Last updated: September 2, 2014
Last verified: September 2014
  Purpose

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


Condition Intervention
Central Serous Chorioretinopathy
Procedure: Photodynamic therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Safe Effective Light Dose of Photodynamic Therapy for Chronic Central Serous Chorioretinopathy

Resource links provided by NLM:


Further study details as provided by Yeungnam University College of Medicine:

Primary Outcome Measures:
  • Changes of best corrected visual acuity [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    Changes of best corrected visual acuity at baseline and 1, 3, 6 month after PDT


Secondary Outcome Measures:
  • Change of central retinal thickness, success rate, recurrence rate, and complications [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 45
Study Start Date: June 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: June 26, 2012
Last Updated: September 2, 2014
Health Authority: Korea: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 23, 2014