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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mingwei Zhao, Peking University People's Hospital
ClinicalTrials.gov Identifier:
NCT01574430
First received: April 8, 2012
Last updated: August 15, 2016
Last verified: August 2016
  Purpose
The purpose of this study is to determine the safety and efficacy of PDT at 30% verteporfin dose in the treatment of CSC.

Condition Intervention Phase
Central Serous Chorioretinopathy
Procedure: PDT
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-masked, Multicenter, Controlled Study of Photodynamic Therapy in Patients With Central Serous Chorioretinopathy

Resource links provided by NLM:


Further study details as provided by Peking University People's Hospital:

Primary Outcome Measures:
  • Change from baseline in BCVA [ Time Frame: 1 week,2 weeks,3 weeks,1 month,3months, 6 months, 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Leakage at RPE level in FA [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
  • Change from baseline in central retinal thickness [ Time Frame: 1 week,2 weeks,3 weeks,1 month,3months, 6 months, 1 year ] [ Designated as safety issue: No ]
  • The incidence rate of adverse event [ Time Frame: 1 week,2 weeks,3 weeks,1 month,3months, 6 months, 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 131
Study Start Date: December 2010
Study Completion Date: December 2014
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01574430

Locations
China, Beijing
People's Hospital of Peking University
Beijing, Beijing, China, 100044
Sponsors and Collaborators
Peking University People's Hospital
Investigators
Study Director: Mingwei Zhao, M.D People's Hospital of Peking University
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 People's Hospital of Peking University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mingwei Zhao, Dr., Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT01574430     History of Changes
Other Study ID Numbers: PDTCSC-CHINA 
Study First Received: April 8, 2012
Last Updated: August 15, 2016
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Central Serous Chorioretinopathy
Retinal Diseases
Eye Diseases
Verteporfin
Photosensitizing Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on September 27, 2016