Clinical Trial: Central Serous Chorioretinopathy Treated by Modified Photodynamic Therapy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Central Serous Chorioretinopathy Treated by Modified Photodynamic Therapy

Brief Summary: 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).

Detailed Summary:

Purpose:

to evaluate the effectiveness as well as the detrimental influence of half-dose and half-fluence modification of verteporfin PDT for the treatment of prolonged unresolved Central Serous Chorioretinopathy (CSCR).

Study Design and Patient Recruitment:

This study was a prospective, randomized, consecutive, open-labeled, comparative interventional case series. Patients with symptomatic acute or chronic CSC of 3 weeks or more duration were recruited. Patients were offered treatment if they had worsening of symptoms or no subjective improvement since the onset of the CSC. Inclusion criteria included 1) patients with best-corrected visual acuity (BCVA) of 20/400 or better; 2) presence of subretinal fluid (SRF) and/or serous pigment epithelial detachment (PED) involving the fovea on optical coherence tomography (OCT); 3) presence of active angiographic leakage in fluorescein angiography (FA) caused by CSC but not CNV or other diseases; and 4) abnormal dilated choroidal vasculature and other features in ICGA consistent with the diagnosis of CSC. Patients who received previous PDT or focal thermal laser photocoagulation for the treatment of CSC or had evidence of CNV, polypoidal choroidal vasculopathy, or other maculopathy on clinical examination, FA, or ICGA were excluded. Informed consent was obtained from all subjects. 12 patients in each group were planned to recruit in each group.

Modified Photodynamic Therapy with Half Dosage:

The Half Dosage PDT protocol for CSC was performed using half the normal dose of verteporfin (Visudyne, Novartis AG, Bülach, Switzerland) i.e., 3 mg/m2 infusion of verteporfin with a rationale that using lower dosage has less collateral damagi
Sponsor: Shin Kong Wu Ho-Su Memorial Hospital

Current Primary Outcome: Effectiveness of both modification for the treatment of chronic CSCR Fluorescent leakage as regards to BCVA OCT changes [ Time Frame: within 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Detrimental influence on choroidal perfusion Represented by the decrease of fluorescent intensity In ICGA [ Time Frame: within 6 months ]

Original Secondary Outcome: Same as current

Information By: Shin Kong Wu Ho-Su Memorial Hospital

Dates:
Date Received: November 19, 2009
Date Started: November 2008
Date Completion:
Last Updated: July 22, 2011
Last Verified: July 2011