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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
History of Changes
  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:

Drug Information available for: Verteporfin
U.S. FDA Resources

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
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 May 21, 2013