At the baseline visit of both the PLACE and SPECTRA trial, demographics and medical history were taken, and an ophthalmologic examination and imaging were performed. This extensive ophthalmologic examination included best-corrected visual acuity in Early Treatment of Diabetic Retinopathy Study letters, and retinal and foveal sensitivity on microperimetry (Macular Integrity Assessment microperimetry, Centervue, Padova, Italy). Imaging included OCT scans, fundus autofluorescence, fundus photographs, fluorescein angiography, ICGA, and were made by certified medical photographers. Patients were randomized to treatment with half-dose PDT or either eplerenone (SPECTRA trial) or high-density subthreshold micropulse laser (PLACE trial). For half-dose PDT, the area to be treated was determined by the central reading center based on hyperfluorescent areas on ICGA compatible with SRF on OCT and leakage on fluorescein angiography.
Before the start of the half-dose PDT, the pupil of the eye to be treated was dilated with topical 1.0% tropicamide and 2.5% phenylephrine. Afterward, 3 mg/m2 body surface verteporfin (Visudyne; Novartis Pharma AG, Basel, Switzerland) was administered over 10 minutes through an intravenous drip. Fifteen minutes after the starting the verteporfin infusion, an anesthetic drop containing oxybuprocaine 0.4% was administered before placing a PDT contact lens (×1.5; Volk Optical, Mentor, OH) on the eye. Finally, half-dose PDT was performed in the target treatment area with a standard fluency of 50 J/cm2, wavelength of 689 nm, and duration of 83 seconds.
At the first visit (6 weeks to 3 months after baseline and treatment) and at the 1-year visit (at 8–12 months after treatment), patients underwent ophthalmologic examination and imaging again. Data of the follow-up at 2 years after the baseline were also collected if present, in most cases, as a final follow-up in the trial setting, but also as a routine follow-up in the clinic.
Before the start of the half-dose PDT, the pupil of the eye to be treated was dilated with topical 1.0% tropicamide and 2.5% phenylephrine. Afterward, 3 mg/m2 body surface verteporfin (Visudyne; Novartis Pharma AG, Basel, Switzerland) was administered over 10 minutes through an intravenous drip. Fifteen minutes after the starting the verteporfin infusion, an anesthetic drop containing oxybuprocaine 0.4% was administered before placing a PDT contact lens (×1.5; Volk Optical, Mentor, OH) on the eye. Finally, half-dose PDT was performed in the target treatment area with a standard fluency of 50 J/cm2, wavelength of 689 nm, and duration of 83 seconds.
At the first visit (6 weeks to 3 months after baseline and treatment) and at the 1-year visit (at 8–12 months after treatment), patients underwent ophthalmologic examination and imaging again. Data of the follow-up at 2 years after the baseline were also collected if present, in most cases, as a final follow-up in the trial setting, but also as a routine follow-up in the clinic.
