Study of Photodynamic Therapy (PDT) in Patients With Central Serous Chorioretinopathy (CSC)

A Randomized, Double-masked, Multicenter, Controlled Study of Photodynamic Therapy in Patients With Central Serous Chorioretinopathy

The purpose of this study is to determine the safety and efficacy of PDT at 30% verteporfin dose in the treatment of CSC.

Study Overview

• Status: Completed
• Conditions: Central Serous Chorioretinopathy
• Intervention / Treatment: Procedure: PDT

• Study Type: Interventional
• Enrollment (Anticipated): 131
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • People's Hospital of Peking University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients with CSC
• patients signed the ICF
• patients with course of CSC less than 6 months
• patients did not undertake any treatment for CSC

Exclusion Criteria:

• patients with porphyria
• patients allergic to verteporfin
• pregnant or nursing women
• poor patients compliance
• sever liver dysfunction
• dioptric media opacities which make it difficult to exam fundus

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
Active Comparator: 50% dose PDT; patients in this group was given 50% verteporfin dose PDT	Procedure: PDT; 30% or 50% verteporfin dose PDT was given to patients with CSC; Other Names: photodynamic therapy
Experimental: 30% dose PDT; patients in this group was given 30% verteporfin dose PDT	Procedure: PDT; 30% or 50% verteporfin dose PDT was given to patients with CSC; Other Names: photodynamic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in BCVA	1 week,2 weeks,3 weeks,1 month,3months, 6 months, 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Leakage at RPE level in FA	1 week
Change from baseline in central retinal thickness	1 week,2 weeks,3 weeks,1 month,3months, 6 months, 1 year
The incidence rate of adverse event	1 week,2 weeks,3 weeks,1 month,3months, 6 months, 1 year

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Investigators: Principal Investigator: Youxin Chen, M.D, Peking Union Medical College; Principal Investigator: Feng Zhang, M.D, Beijing Tongren Hospital of Capital Medical University; Principal Investigator: Hong Dai, M.D, Beijing Hospital; Study Chair: Xiaoxin Li, M.D, Peking University People's Hospital

Publications and helpful links

General Publications

• Zhao M, Zhang F, Chen Y, Dai H, Qu J, Dong C, Kang X, Liu Y, Yang L, Li Y, Zhou P, Pan CT, Zhang L, Liu P, Zhou H, Jiao X, Xiong Y, Tian R, Lu Y, Yu X, Li X. A 50% vs 30% dose of verteporfin (photodynamic therapy) for acute central serous chorioretinopathy: one-year results of a randomized clinical trial. JAMA Ophthalmol. 2015 Mar;133(3):333-40. doi: 10.1001/jamaophthalmol.2014.5312.

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: April 8, 2012
• First Submitted That Met QC Criteria: April 9, 2012
• First Posted (Estimate): April 10, 2012

Study Record Updates

• Last Update Posted (Estimate): August 16, 2016
• Last Update Submitted That Met QC Criteria: August 15, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

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