Different Doses of vPDT in the Treatment of cCSC

Not Applicable

• Conditions: Therapy, Photodynamic; Central Serous Chorioretinopathy
• Interventions: Procedure: 50% dose of photodynamic therapy; Procedure: 70% dose of photodynamic therapy

• Registration Number: NCT05390619
• Lead Sponsor: Peking University People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Status Verified: 2022-05
• Study First Submitted: 2022-05-17
• Study First Submitted QC: 2022-05-21
• Last Update Submitted: 2022-05-21
• Study First Posted: 2022-05-25
• Last Update Posted: 2022-05-25
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
50% dose of PDT	50% dose of photodynamic therapy	Patients received 50% dose of verteporfin PDT therapy.
70% dose of PDT	70% dose of photodynamic therapy	Patients received 70% dose of verteporfin PDT therapy.

Primary Outcome Measures

Name	Time	Method
The complete absorption rate of subretinal fluid	3 months after the primary PDT	The absorption of subretinal fluid was observed on optical coherence tomography at each follow up visit

Secondary Outcome Measures

Name	Time	Method
Best corrected visual acuity change after the PDT	12 months after the PDT	The BCVA was tested at each visit
Subfoveal choroidal thickness change after the PDT	12 months after the PDT	The hight of Subfoveal choroidal thickness was measured on optical coherence tomography at each visit
Central foveal thickness change after the PDT	12 months after the PDT	The hight of central foveal thickness was measured on optical coherence tomography at each visit

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China