Different Doses of vPDT in the Treatment of cCSC

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

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.

Study Overview

• Status: Recruiting
• Conditions: Central Serous Chorioretinopathy; Therapy, Photodynamic
• Intervention / Treatment: Procedure: 50% dose of photodynamic therapy; Procedure: 70% dose of photodynamic therapy

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuou Yao, Dr; Phone Number: 13651177854; Email: yaoyoyo19@139.com
• Study Contact Backup: Name: Mingwei Zhao, Dr; Phone Number: 13801057408; Email: dr_mingweizhao@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Recruiting
      • Peking University People's Hospital
      • Contact: Yuou Yao, Dr; Email: yaoyoyo19@139.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 50% dose of PDT; Patients received 50% dose of verteporfin PDT therapy.	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.
Experimental: 70% dose of PDT; Patients received 70% dose of verteporfin PDT therapy.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Best corrected visual acuity change after the PDT	The BCVA was tested at each visit	12 months after the PDT

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Investigators: Study Chair: Yuou Yao, Dr, Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: May 17, 2022
• First Submitted That Met QC Criteria: May 21, 2022
• First Posted (Actual): May 25, 2022

Study Record Updates

• Last Update Posted (Actual): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 21, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Central Serous Chorioretinopathy
• Other Study ID Numbers: RDL2020-04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No