The Safe Effective Light Dose of Photodynamic Therapy for Chronic Central Serous Chorioretinopathy
1 other identifier
interventional
45
1 country
1
Brief Summary
To find the safe effective lowest light dose for photodynamic therapy (PDT). in the treatment of central serous chorioretinopathy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 26, 2012
CompletedFirst Posted
Study publicly available on registry
June 28, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedFebruary 16, 2015
February 1, 2015
2.3 years
June 26, 2012
February 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes of best corrected visual acuity
Changes of best corrected visual acuity at baseline and 1, 3, 6 month after PDT
6 month
Secondary Outcomes (1)
Change of central retinal thickness, success rate, recurrence rate, and complications
6 months
Study Arms (3)
50% group
EXPERIMENTALpower of PDT is applied to the patients at 50% of the full energy based on TAP study.
40% group
EXPERIMENTALDecreasing power of PDT is applied to the patients at 40% of the full energy based on TAP study.
30% group
EXPERIMENTALDecreasing power of PDT is applied to the patients at 30% of the full energy based on TAP study.
Interventions
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 Criteria
You may qualify if:
- Idiopathic detachment of the neurosensory retina with a focal leak at the level of the RPE with FA
- Presence of SRF and/or serous pigment epithelial detachment on optical coherence tomography (OCT)
- Presence of abnormal dilated choroidal vasculature in ICGA
- Patients with symptomatic CSC of at least 3 months duration
You may not qualify if:
- 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
- Patients receiving exogenous corticosteroid treatment
- Patients with systemic diseases such as Cushing's disease or renal diseases
- Pregnant patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yeungnam University College of Medicine
Daegu, South Korea
Related Publications (1)
Park DG, Jeong S, Noh D, Sagong M. Optimal fluence rate of photodynamic therapy for chronic central serous chorioretinopathy. Br J Ophthalmol. 2021 Jun;105(6):844-849. doi: 10.1136/bjophthalmol-2020-316837. Epub 2020 Jul 29.
PMID: 32727733DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 26, 2012
First Posted
June 28, 2012
Study Start
June 1, 2012
Primary Completion
October 1, 2014
Study Completion
March 1, 2015
Last Updated
February 16, 2015
Record last verified: 2015-02