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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE April 8, 2012
First Posted Date  ICMJE April 10, 2012
Last Update Posted Date August 16, 2016
Study Start Date  ICMJE December 2010
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2012)
Change from baseline in BCVA [ Time Frame: 1 week,2 weeks,3 weeks,1 month,3months, 6 months, 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2012)
  • Leakage at RPE level in FA [ Time Frame: 1 week ]
  • Change from baseline in central retinal thickness [ Time Frame: 1 week,2 weeks,3 weeks,1 month,3months, 6 months, 1 year ]
  • The incidence rate of adverse event [ Time Frame: 1 week,2 weeks,3 weeks,1 month,3months, 6 months, 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Photodynamic Therapy (PDT) in Patients With Central Serous Chorioretinopathy (CSC)
Official Title  ICMJE A Randomized, Double-masked, Multicenter, Controlled Study of Photodynamic Therapy in Patients With Central Serous Chorioretinopathy
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Central Serous Chorioretinopathy
Intervention  ICMJE Procedure: PDT
30% or 50% verteporfin dose PDT was given to patients with CSC
Other Name: photodynamic therapy
Study Arms  ICMJE
  • Active Comparator: 50% dose PDT
    patients in this group was given 50% verteporfin dose PDT
    Intervention: Procedure: PDT
  • Experimental: 30% dose PDT
    patients in this group was given 30% verteporfin dose PDT
    Intervention: Procedure: PDT
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: August 15, 2016)
131
Original Estimated Enrollment  ICMJE
 (submitted: April 9, 2012)
120
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01574430
Other Study ID Numbers  ICMJE PDTCSC-CHINA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mingwei Zhao, Peking University People's Hospital
Study Sponsor  ICMJE Peking University People's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Peking University People's Hospital
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP