Combination Photodynamic Therapy and Bevacizumab Reduces the Retreatment Rate in a Randomized, Controlled, Double-Masked Study of Low and Very Low Fluence Laser in Age-Related Macular Degeneration

Abstract

Purpose: : To determine if verteporfin photodynamic therapy (PDT), at low or very low fluence rates, combined with bevacizumab will reduce the number of treatments required over 6 months in patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD), compared with bevacizumab alone.

Methods: : In this 6-month randomized controlled clinical trial, 36 subjects were assigned to one of three treatment groups: bevacizumab + low fluence (300 mW/cm²) verteporfin PDT (B+LF); bevacizumab + very low fluence (150 mW/cm²) verteporfin PDT (B+VLF); or bevacizumab + sham PDT (B). Intravitreal bevacizumab was delivered within 2 hours of PDT at baseline. Patients returned monthly thereafter for best-corrected ETDRS visual acuity (VA) testing, optical coherence tomography (OCT), and ocular examination. Retreatment decisions were based primarily on OCT. PDT was administered at months 3, 4, 5 or 6, with a minimum 3-month interval between verteporfin/sham PDT treatments.

Results: : As of December 2007, 6-month data were available for 31 of 36 enrolled patients. The average number of bevacizumab treatments in the bevacizumab only group was 5.1, compared to 2.7 in the low fluence and 2.4 in the very low fluence groups. Over 6 months, patients who were treated in the B+LF and B+VLF groups required significantly fewer treatments on average than those treated with bevacizumab alone (p=0.011 and p=0.001 respectively). Each group experienced an average improvement in VA (5.6, p>0.05; 14.1, p=0.003; and 9.1, p=0.005 letters, respectively).

Conclusions: : Bevacizumab combined with low or very low fluence verteporfin PDT reduces the number of bevacizumab treatments required over 6 months in patients with CNV secondary to AMD. Visual acuities responded favorably in all categories.

Clinical Trial: : www.clinicaltrials.gov NCT00359164

Keywords: choroid: neovascularization • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • age-related macular degeneration