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

Phase 4

Completed

• Conditions: Central Serous Chorioretinopathy
• Interventions: Procedure: PDT

• Registration Number: NCT01574430
• Lead Sponsor: Peking University People's Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2012-04-08
• Study First Submitted QC: 2012-04-09
• Study First Posted: 2012-04-10
• Primary Completion: 2012-12
• Study Completion: 2014-12
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-15
• Last Update Posted: 2016-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
30% dose PDT	PDT	patients in this group was given 30% verteporfin dose PDT
50% dose PDT	PDT	patients in this group was given 50% verteporfin dose PDT

Primary Outcome Measures

Name	Time	Method
Change from baseline in BCVA	1 week,2 weeks,3 weeks,1 month,3months, 6 months, 1 year

Secondary Outcome Measures

Name	Time	Method
The incidence rate of adverse event	1 week,2 weeks,3 weeks,1 month,3months, 6 months, 1 year
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

Trial Locations

Locations (1)

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