Viewing Study NCT00331435



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Study NCT ID: NCT00331435
Status: COMPLETED
Last Update Posted: 2011-03-31
First Post: 2006-05-30

Brief Title: PDT Study for Exudative AMD With PCV
Sponsor: Ophthalmic PDT Study Group
Organization: Ophthalmic PDT Study Group

Study Overview

Official Title: Clinical Research of Photodynamic Therapy for Exudative Age-related Macular Degeneration Accompanied With Polypoidal Choroidal Vasculopathy
Status: COMPLETED
Status Verified Date: 2011-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study is to evaluate and conduct an exploratory comparison of the efficacy and safety of indocyanine green angiography ICGA guided photodynamic therapy PDT and fluorescein angiography FA guided PDT for exudative age-related macular degeneration AMD accompanied with polypoidal choroidal vasculopathy PCV
Detailed Description: PDT with verteporfin has been proven beneficial for patients with AMD The laser spot size is decided based on FA finding FA guided PDT ICGA is needed to detect PCV lesions such as polypoidal lesions or abnormal network vessels In clinical practice PDT based on ICGA ICGA guided PDT has and is being conducted for the treatment of AMD with PCV However there are no reports on the outcomes of prospective research of PDT for PCV in Japanese patients Furthermore there are no reports comparing FA guided PDT and ICGA guided PDT

We propose to conduct this clinical research in order to investigate the efficacy and safety of PDT for PCV in Japanese patients and to compare results of FA guided PDT and ICGA guided PDT

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None