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Completed

NCT Number: NCT01574430

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

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

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Key information

Conditions

Central Serous Chorioretinopathy Eye Diseases Retinal Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

People's Hospital of Peking University

Beijing, Beijing Municipality, 100044, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PDT

Procedure

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

Other names: photodynamic therapy

Primary outcomes

  1. Change from baseline in BCVA

    Time frame: 1 week,2 weeks,3 weeks,1 month,3months, 6 months, 1 year

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2014
First posted
Apr 10, 2012
Registry last updated
Aug 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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