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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2014

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: 50% group
    • power of PDT is applied to the patients at 50% of the full energy based on TAP study.
  • Experimental: 40% group
    • Decreasing power of PDT is applied to the patients at 40% of the full energy based on TAP study.
  • Experimental: 30% group
    • Decreasing power of PDT is applied to the patients at 30% of the full energy based on TAP study.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Yeungnam University College of Medicine
  • Provider of Information About this Clinical Study
    • Principal Investigator: Min Sagong, Assistant Professor – Yeungnam University College of Medicine
  • Overall Contact(s)
    • Min Sagong, 82-53-620-4191, msagong@ynu.ac.kr

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