Back to resultsDifferent Doses of vPDT in the Treatment of cCSC
Primary Purpose
Central Serous Chorioretinopathy, Therapy, Photodynamic
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
50% dose of photodynamic therapy
70% dose of photodynamic therapy
Sponsored by
About this trial
This is an interventional treatment trial for Central Serous Chorioretinopathy
Eligibility Criteria
Inclusion Criteria:
- 18-75 years old, regardless of gender;
- Meet the diagnostic criteria of central serous chorioretinopathy;
- The course of CSC (subject to the symptoms of this disease) is more than 3 months;
- Patients with simultaneous diseases of both eyes were included in those with more subretinal fluid.
Exclusion Criteria:
- macular neuroretinal detachment caused by rhegmatogenous retinal detachment, uveitis, age-related macular degeneration, polypoid choroidal angiopathy and other fundus diseases;
- a previous history of PDT treatment;
- systemic hormone or local hormone nasal spray is being used, or hormone is stopped for less than 3 months.
Sites / Locations
- Peking University People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
50% dose of PDT
70% dose of PDT
Arm Description
Patients received 50% dose of verteporfin PDT therapy.
Patients received 70% dose of verteporfin PDT therapy.
Outcomes
Primary Outcome Measures
The complete absorption rate of subretinal fluid
The absorption of subretinal fluid was observed on optical coherence tomography at each follow up visit
Secondary Outcome Measures
Central foveal thickness change after the PDT
The hight of central foveal thickness was measured on optical coherence tomography at each visit
Subfoveal choroidal thickness change after the PDT
The hight of Subfoveal choroidal thickness was measured on optical coherence tomography at each visit
Best corrected visual acuity change after the PDT
The BCVA was tested at each visit
Full Information
NCT ID
NCT05390619
First Posted
May 17, 2022
Last Updated
May 21, 2022
Sponsor
Peking University People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05390619
Brief Title
Different Doses of vPDT in the Treatment of cCSC
Official Title
Comparison of Different Doses of Verteporfin Photodynamic Therapy in the Treatment of Chronic Central Serous Chorioretinopathy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a prospective, randomized and controlled clinical trial of photodynamic therapy (PDT) for chronic central serous chorioretinopathy (CSC). The patients who met the inclusion criteria were randomly divided into 50% dose PDT treatment group and 70% dose PDT treatment group. The primary treatment success rate and adverse event rate of the two groups were compared by optical coherence tomography (OCT), and then the best PDT treatment scheme for chronic CSC was summarized.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Serous Chorioretinopathy, Therapy, Photodynamic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
50% dose of PDT
Arm Type
Experimental
Arm Description
Patients received 50% dose of verteporfin PDT therapy.
Arm Title
70% dose of PDT
Arm Type
Experimental
Arm Description
Patients received 70% dose of verteporfin PDT therapy.
Intervention Type
Procedure
Intervention Name(s)
50% dose of photodynamic therapy
Intervention Description
Verteporfin (Visudyne; Novartis, Switzerland) was administrated intravenously over 10 minutes with 50% doses based on the randomization . Fifteen minutes after commencing the verteporfin infusion, a contact lens (Volk® area centralis) was positioned on the affected eye, the treatment area was exposed to a 689 nm laser with a fluence of 600 mw/cm2 for 83 seconds and a total laser energy of 50 J/cm2.
Intervention Type
Procedure
Intervention Name(s)
70% dose of photodynamic therapy
Intervention Description
Verteporfin (Visudyne; Novartis, Switzerland) was administrated intravenously over 10 minutes with 70% doses based on the randomization . Fifteen minutes after commencing the verteporfin infusion, a contact lens (Volk® area centralis) was positioned on the affected eye, the treatment area was exposed to a 689 nm laser with a fluence of 600 mw/cm2 for 83 seconds and a total laser energy of 50 J/cm2.
Primary Outcome Measure Information:
Title
The complete absorption rate of subretinal fluid
Description
The absorption of subretinal fluid was observed on optical coherence tomography at each follow up visit
Time Frame
3 months after the primary PDT
Secondary Outcome Measure Information:
Title
Central foveal thickness change after the PDT
Description
The hight of central foveal thickness was measured on optical coherence tomography at each visit
Time Frame
12 months after the PDT
Title
Subfoveal choroidal thickness change after the PDT
Description
The hight of Subfoveal choroidal thickness was measured on optical coherence tomography at each visit
Time Frame
12 months after the PDT
Title
Best corrected visual acuity change after the PDT
Description
The BCVA was tested at each visit
Time Frame
12 months after the PDT
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-75 years old, regardless of gender;
Meet the diagnostic criteria of central serous chorioretinopathy;
The course of CSC (subject to the symptoms of this disease) is more than 3 months;
Patients with simultaneous diseases of both eyes were included in those with more subretinal fluid.
Exclusion Criteria:
macular neuroretinal detachment caused by rhegmatogenous retinal detachment, uveitis, age-related macular degeneration, polypoid choroidal angiopathy and other fundus diseases;
a previous history of PDT treatment;
systemic hormone or local hormone nasal spray is being used, or hormone is stopped for less than 3 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuou Yao, Dr
Phone
13651177854
Email
yaoyoyo19@139.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mingwei Zhao, Dr
Phone
13801057408
Email
dr_mingweizhao@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuou Yao, Dr
Organizational Affiliation
Peking University People's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuou Yao, Dr
Email
yaoyoyo19@139.com
12. IPD Sharing Statement
Learn more about this trial
Different Doses of vPDT in the Treatment of cCSC
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