Back to results

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

Primary Purpose

Central Serous Chorioretinopathy

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

PDT

About this trial

This is an interventional treatment trial for Central Serous Chorioretinopathy

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

People's Hospital of Peking University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

50% dose PDT

30% dose PDT

Arm Description

patients in this group was given 50% verteporfin dose PDT

patients in this group was given 30% verteporfin dose PDT

Outcomes

Primary Outcome Measures

Change from baseline in BCVA

Secondary Outcome Measures

Leakage at RPE level in FA

Change from baseline in central retinal thickness

The incidence rate of adverse event

Full Information

NCT ID

NCT01574430

First Posted

April 8, 2012

Last Updated

August 15, 2016

Sponsor

Peking University People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01574430

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

December 2010 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University People's Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Central Serous Chorioretinopathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

131 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

50% dose PDT

Arm Type

Active Comparator

Arm Description

patients in this group was given 50% verteporfin dose PDT

Arm Title

30% dose PDT

Arm Type

Experimental

Arm Description

patients in this group was given 30% verteporfin dose PDT

Intervention Type

Procedure

Intervention Name(s)

PDT

Other Intervention Name(s)

photodynamic therapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Change from baseline in BCVA

Time Frame

1 week,2 weeks,3 weeks,1 month,3months, 6 months, 1 year

Secondary Outcome Measure Information:

Title

Leakage at RPE level in FA

Time Frame

1 week

Title

Change from baseline in central retinal thickness

Time Frame

1 week,2 weeks,3 weeks,1 month,3months, 6 months, 1 year

Title

The incidence rate of adverse event

Time Frame

1 week,2 weeks,3 weeks,1 month,3months, 6 months, 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: