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

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ClinicalTrials.gov Identifier: NCT01574430
Recruitment Status : Completed
First Posted : April 10, 2012
Last Update Posted : August 16, 2016
Sponsor:
Information provided by (Responsible Party):
Mingwei Zhao, Peking University People's Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Central Serous Chorioretinopathy Procedure: PDT Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 131 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-masked, Multicenter, Controlled Study of Photodynamic Therapy in Patients With Central Serous Chorioretinopathy
Study Start Date : December 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2014

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Arms and Interventions
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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 Name: 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 Name: photodynamic therapy


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in BCVA [ Time Frame: 1 week,2 weeks,3 weeks,1 month,3months, 6 months, 1 year ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574430


Locations
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China, Beijing
People's Hospital of Peking University
Beijing, Beijing, China, 100044
Sponsors and Collaborators
Peking University People's Hospital
Investigators
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Study Director: Mingwei Zhao, M.D Peking University People's Hospital
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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mingwei Zhao, Dr., Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT01574430    
Other Study ID Numbers: PDTCSC-CHINA
First Posted: April 10, 2012    Key Record Dates
Last Update Posted: August 16, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Central Serous Chorioretinopathy
Retinal Diseases
Eye Diseases