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M. Rabena, D. Pieramici, M. Nasir, A. Castellarin, R. See, J. Basefsky, R. Avery; Standard and Low Fluence PDT in Combination With Bevacizumab in the Treatment of CNV Associated With AMD. Invest. Ophthalmol. Vis. Sci. 2008;49(13):562.
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A pilot trial of combination intravitreal bevacizumab (IVB) and photodynamic therapy (PDT) with verteporfin at standard and reduced fluence levels in treatment naïve patients with subfoveal CNV due to age-related macular degeneration (AMD).
Patients were enrolled in this prospective, single center, randomized, investigator-sponsored pilot clinical trial to evaluate IVB (1.25mg) in combination with verteporfin PDT. Patients were randomized to receive verteporfin PDT (standard fluence [600mw/cm2] or reduced fluence [300mw/cm2]) followed by same day IVB (1.25mg). Patients underwent complete ophthalmologic examination including ocular coherence tomography (OCT) and fluorescein angiography (FA). Patients were reevaluated every 4-6 weeks for retreatment with bevacizumab only based on OCTand every 10-12 weeks for retreatment with verteporfin PDT and bevacizumab (on the same day), based on FA and OCT findings. Participants in the study are to be monitored for two years.
Twenty patients (N=9 occult, N=8 minimally classic, N=3 predominantly classic) were randomized into the study (N=11 standard fluence, N=9 reduced fluence). At baseline, the mean greatest linear distance was 4.03mm (median 3.33mm, range 1.8mm to 10.4mm). After 3 and 6 months of follow-up, mean VA improved by 6 ± 4.72 letters and 4 ± 5.04 letters, respectively, compared to baseline; and central retinal thickness showed a mean decrease of 86.79± 9.64µm and 81.29± 17.88µm, respectively, compared to baseline. The average number of verteporfin PDT treatments and bevacizumab injections were 1.45 and 1.5 at 6 months. No significant differences were observed between the standard and reduced fluence groups. No patients experienced any severe ocular or systemic adverse events.
At 6 months, in this small pilot study, combination verteporfin PDT and IVB was well tolerated, resulted in improved visual acuity, and decreased CNV leakage by OCT and fluorescein angiography. No significant differences between standard and low fluence PDT were identified.
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