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

Central Serous Chorioretinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01630863
• Other study ID #: YUH-12-007-D4
• Status: Recruiting
• Phase: N/A
• First received: June 26, 2012
• Last updated: February 13, 2015
• Start date: June 2012
• Est. completion date: March 2015

Study information

• Verified date: February 2015
• Source: Yeungnam University College of Medicine
• Contact: Min Sagong
• Phone: 82-53-620-4191
• Email: msagong[@]ynu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: March 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Central Serous Chorioretinopathy

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Yeungnam University College of Medicine	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Yeungnam University College of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of best corrected visual acuity	Changes of best corrected visual acuity at baseline and 1, 3, 6 month after PDT	6 month	No
Secondary	Change of central retinal thickness, success rate, recurrence rate, and complications	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.	6 months	No