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

NCT ID: NCT01630863

Last Updated: 2015-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2015-03-31

Brief Summary

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

Detailed Description

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Conditions

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Central Serous Chorioretinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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50% group

power of PDT is applied to the patients at 50% of the full energy based on TAP study.

Group Type EXPERIMENTAL

Photodynamic therapy

Intervention Type PROCEDURE

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.

40% group

Decreasing power of PDT is applied to the patients at 40% of the full energy based on TAP study.

Group Type EXPERIMENTAL

Photodynamic therapy

Intervention Type PROCEDURE

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.

30% group

Decreasing power of PDT is applied to the patients at 30% of the full energy based on TAP study.

Group Type EXPERIMENTAL

Photodynamic therapy

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yeungnam University College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Min Sagong

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Yeungnam University College of Medicine

Daegu, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Min Sagong

Role: CONTACT

82-53-620-4191

Facility Contacts

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Min Sagong

Role: primary

82-53-620-4191

References

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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.

Reference Type DERIVED
PMID: 32727733 (View on PubMed)

Other Identifiers

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YUH-12-007-D4

Identifier Type: -

Identifier Source: org_study_id

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