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

Central Serous Chorioretinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01574430
• Other study ID #: PDTCSC-CHINA
• Status: Completed
• Phase: Phase 4
• First received: April 8, 2012
• Last updated: August 15, 2016
• Start date: December 2010
• Est. completion date: December 2014

Study information

• Verified date: August 2016
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: December 2014
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Central Serous Chorioretinopathy

Intervention

Procedure:
• PDT
30% or 50% verteporfin dose PDT was given to patients with CSC

Locations

Country	Name	City	State
China	People's Hospital of Peking University	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	Change from baseline in BCVA		1 week,2 weeks,3 weeks,1 month,3months, 6 months, 1 year	No
Secondary	Leakage at RPE level in FA		1 week	Yes
Secondary	Change from baseline in central retinal thickness		1 week,2 weeks,3 weeks,1 month,3months, 6 months, 1 year	No
Secondary	The incidence rate of adverse event		1 week,2 weeks,3 weeks,1 month,3months, 6 months, 1 year	No