Photodynamic therapy with half dose verteporfin for central serous chorioretinopathy:Prospective intervention trial

UMIN ID: UMIN000002229

Registered date:20/07/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Central serous chorioretinopathy
• Date of first enrollment: 2009/06/01
• Target sample size: 10
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 3mg/m2 intravenous infusion of verteporfin over 10 minutes followed by delivery of diode laser at 689nm 15 minutes after the start of the infusion. Light dose rate is 600 mW/cm2, time of photosensitization is 83 seconds, and total light energy is 50J/cm2.

Outcome(s)

• Primary Outcome: resolution of serous retinal detachment of 4 days, 1 month, 3 months and 1 year after PDT
• Secondary Outcome: 1)visual acuity 2)optical coherence tomography 3)amplitudes and implicit time of a-wave, b-wave and odcillatory potentials recorded by focal macula electroretinogram 4)visual field 5)fluorescein angiography 6)indocyanine green angiography time of assessment 1)-5) : 4 days, 1 month, 3 months and 1 year after PDT 6),7) : 1 month, 3 months and 1 year after PDT

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: 1. drug allery to verteporfin 2. pregnant or expecting pregnancy 3. porphyria, or hypersensitivity to artificial illumination 4. macular diseases other than CSC 5. others (inappropriate case judged by investigator or subinvestigators)

Related Information

• Primary Sponsor: Nagoya University School of Medicine Department of Ophthalmology
• Source(s) of Monetary Support: None