Different Doses of vPDT in the Treatment of cCSC

Central Serous Chorioretinopathy Clinical Trial

Official title:

Comparison of Different Doses of Verteporfin Photodynamic Therapy in the Treatment of Chronic Central Serous Chorioretinopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05390619
• Other study ID #: RDL2020-04
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2022
• Source: Peking University People's Hospital
• Contact: Yuou Yao, Dr
• Phone: 13651177854
• Email: yaoyoyo19[@]139.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Central Serous Chorioretinopathy
• Therapy, Photodynamic

Intervention

Procedure:
• 50% dose of photodynamic therapy
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.
• 70% dose of photodynamic therapy
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.

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The complete absorption rate of subretinal fluid	The absorption of subretinal fluid was observed on optical coherence tomography at each follow up visit	3 months after the primary PDT
Secondary	Central foveal thickness change after the PDT	The hight of central foveal thickness was measured on optical coherence tomography at each visit	12 months after the PDT
Secondary	Subfoveal choroidal thickness change after the PDT	The hight of Subfoveal choroidal thickness was measured on optical coherence tomography at each visit	12 months after the PDT
Secondary	Best corrected visual acuity change after the PDT	The BCVA was tested at each visit	12 months after the PDT