Central Serous Chorioretinopathy Treated by Modified Photodynamic Therapy

This study has been completed.
Sponsor:
Information provided by:
Shin Kong Wu Ho-Su Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01019668
First received: November 19, 2009
Last updated: July 22, 2011
Last verified: July 2011
  Purpose

The purpose of this study is to evaluate the effectiveness as well as the detrimental influence of half-dose and half-fluence modification of verteporfin photodynamic therapy (PDT) for the treatment of prolonged unresolved central serous chorioretinopathy (CSCR).


Condition Intervention
Central Serous Chorioretinopathy
Drug: Verteporfin PDT, half-dose
Drug: verteporfin PDT, half-fluence

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Central Serous Chorioretinopathy Treated by Modified Photodynamic Therapy

Resource links provided by NLM:


Further study details as provided by Shin Kong Wu Ho-Su Memorial Hospital:

Primary Outcome Measures:
  • Effectiveness of both modification for the treatment of chronic CSCR Fluorescent leakage as regards to BCVA OCT changes [ Time Frame: within 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Detrimental influence on choroidal perfusion Represented by the decrease of fluorescent intensity In ICGA [ Time Frame: within 6 months ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: November 2008
Study Completion Date: June 2011
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: verteporfin PDT, half-dose
use different modification of verteporfin PDT to treat prolonged unresolved central serous chorioretinopathy
Drug: Verteporfin PDT, half-dose
half the regular dose or half the regular laser fluence to treat prolonged unresolved CSCR
Other Name: visudyne
Drug: verteporfin PDT, half-fluence
half the regular dose or half the regular laser fluence to treat prolonged unresolved CSCR
Other Name: visudyne
Active Comparator: verteporfin PDT, half-fluence
use different modification of verteporfin PDT to treat prolonged unresolved central serous chorioretinopathy
Drug: Verteporfin PDT, half-dose
half the regular dose or half the regular laser fluence to treat prolonged unresolved CSCR
Other Name: visudyne
Drug: verteporfin PDT, half-fluence
half the regular dose or half the regular laser fluence to treat prolonged unresolved CSCR
Other Name: visudyne

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with best-corrected visual acuity (BCVA) of 20/200 or better
  • Presence of subretinal fluid (SRF) and/or serous pigment epithelial detachment (PED) involving the fovea on optical coherence tomography (OCT)
  • Presence of active angiographic leakage in fluorescein angiography (FA) caused by CSC but not CNV or other diseases
  • Abnormal dilated choroidal vasculature and other features in ICGA consistent with the diagnosis of CSC.

Exclusion Criteria:

  • Patients who received previous PDT or focal thermal laser photocoagulation for the treatment of CSC.
  • Patients had evidence of CNV, polypoidal choroidal vasculopathy, or other maculopathy on clinical examination, FA, or ICGA
  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: NCT01019668

Locations
Taiwan
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan, 111
Sponsors and Collaborators
Shin Kong Wu Ho-Su Memorial Hospital
Investigators
Principal Investigator: Cheng-Kuo Cheng, MD Shin-Kong Wu Ho-Su Memorial Hospital, School of Medicine, Fu-Jen Catholic University
  More Information

No publications provided

Responsible Party: Cheng-Kuo Cheng, Assistant professor and attending physician of Ophthalmology, Shin-Kong Wu Ho-Su Memorial Hospital, School of Medicine, Fu-Jen Catholic University
ClinicalTrials.gov Identifier: NCT01019668     History of Changes
Other Study ID Numbers: SKH-8302-98-DR-27
Study First Received: November 19, 2009
Last Updated: July 22, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by Shin Kong Wu Ho-Su Memorial Hospital:
chorioretinopathy
photodynamic therapy
reduced fluence
reduced dose

Additional relevant MeSH terms:
Central Serous Chorioretinopathy
Retinal Diseases
Eye Diseases
Verteporfin
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014