Triple Plus Therapy Compared With Monthly Ranibizumab Reduces the Retreatment Rate in a Randomized Study in Age-Related Macular Degeneration

Abstract

Purpose: : A randomized controlled clinical trial was performed to determine if triple therapy plus with verteporfin reduced duration photodynamic therapy (rd-PDT) + intravitreal dexamethasone (DEX) + ranibizumab (LUC) with LUC booster, would reduce the number of treatments required in patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD), compared with LUC alone.

Methods: : 60 treatment naïve subjects were assigned to one of two treatment groups: Group 1: monthly LUC (0.5mg) injections (n=30) or Group 2: triple therapy plus with rd-PDT (42 seconds at 600 mW/cm² at a light dose of 25 J/cm² ) + intravitreal DEX (0.8mg) within 2 hours + LUC (0.5 mg) within 3 to 7 days after rd-PDT + a single LUC booster 1 month after initial triple therapy (n=30). Patients returned monthly for ETDRS visual acuity (VA) testing, optical coherence tomography (OCT) and ocular examination and every 3 months for fluorescein angiography (FA). Retreatment decisions were based on OCT and FA. LUC was repeated in Group 2 every 4 weeks if there was evidence of fluid on OCT or central retinal thickness (CRT) increased by >50 µm, or visual acuity decreased by 5 letters or more, or there was evidence of new blood. Rd-PDT + DEX + LUC was repeated for leakage on FA at month 3 followed by LUC booster 1 month later.

Results: : As of December 2008, 9-month data were analyzed. Group 1 patients received 9.0 LUC injections, compared to 2.6 LUC with 1.3 rd-PDTs in Group 2. At 9 months, 56.7% of Group 1 patients had no leakage on FA or OCT. At 9 months 70% of Group 2 patients exhibited no leakage on FA or OCT following a single triple therapy + single LUC. At 9 months 30% of Group 2 patients received two triple therapy + LUC boosters. Average improvement in VA was 8.6 letters in Group 1 and 12.1 letters in Group 2.

Conclusions: : A regimen of rd-PDT + intravitreal DEX + LUC with 1 month LUC booster reduces the number of LUC treatments required over 9 months in patients with wet AMD compared with monthly LUC, with favorable final visual acuities. 12 month data will be reported. Further investigation is warranted.

Clinical Trial: : www.clinicaltrials.gov NCT00794923

Keywords: age-related macular degeneration • photodynamic therapy • vascular endothelial growth factor