140
Participants
Start Date
December 31, 2013
Primary Completion Date
May 31, 2017
Study Completion Date
May 31, 2017
Half-dose photodynamic therapy (PDT)
"At exactly 15 minutes after the start of the half-dose verteporfin infusion, the PDT treatment will take place. The area that has to be treated with the PDT laser is determined based on those hyperfluorescent area(s) on mid-phase (approximately 10 minutes) ICG-angiography that correspond to subretinal fluid accumulation in the macula on the OCT scan and hyperfluorescent hot spots on the mid-phase (approximately 3 minutes) fluorescein angiogram. The spot size will be defined based on diameter of the hyperfluorescent area on ICG angiography plus 1mm. The treatment is performed with standard fluency (50 J/cm2), a PDT laser wavelength of 689 nm, and a standard treatment duration of 83 seconds."
Micropulse laser (ML) treatment
"The following ML treatment settings will be used: a power of 1800 mW\*, a duty cycle of 5%, frequency of 500 Hz, exposure time of 0.2 s per spot, spot size: 125 µm, minimal distance of spot from fovea: 500 µm.~\* Subthreshold treatment is desired, meaning that no visible reaction due to laser treatment has to be seen in the retina. In virtually all patients, a power of 1800 mW wil not produce a visible discoloration of the retina after application of a laser spot with the aforementioned settings. If retinal discoloration is seen at a power of 1800 mW the power will be reduced with steps of 300 mW until there is no visible reaction. The first laser test spot will always be applied just outside the macular area."
Cologne University Eye Clinic, Cologne
Creteil University Eye Clinic, Paris
Leiden University Medical Center, Leiden
Radboud University Nijmegen Medical Centre, Institute of Ophthalmology, Nijmegen
Oxford University Eye Hospital, John Radcliffe Hospital, Oxford
University of Cologne
OTHER
University of Oxford
OTHER
Leiden University Medical Center
OTHER
University Hospital, Paris
OTHER
Radboud University Medical Center
OTHER