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Nathan Steinle, Avanti Ghanekar, Carlos Quezada-Ruiz; Ranibizumab versus verteporfin photodynamic therapy for myopic choroidal neovascularization: Results from RADIANCE. Invest. Ophthalmol. Vis. Sci. 2017;58(8):5920.
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According to Intelligent Research in Sight (IRIS®) Registry data, myopic choroidal neovascularization (mCNV) affected over 41,000 patients in the US in 2014 (Willis JR et al. Ophthalmology. 2016;123(8):1771-1782). The previous FDA-approved mCNV treatment of verteporfin photodynamic therapy (vPDT) stabilized visual acuity (VA) without improvement (VIP clinical trial, VIP Study Group. Ophthalmology. 2001;108(5):841-852 and VIP Study Group. Ophthalmology. 2003;110(4):667-673). The prospective RADIANCE trial, which has received limited attention in the US, directly compared the anti-vascular endothelial growth factor agent ranibizumab (RBZ) to vPDT to investigate which treatment provided the best VA outcomes for patients with mCNV.
RADIANCE was a phase 3, randomized, double-masked clinical trial conducted in patients with visual impairment due to mCNV. Patients (N=277) were randomized 2:2:1 into 2 RBZ treatment arms and a vPDT arm. Patients treated with RBZ received RBZ 0.5-mg injections on day 1, at month (M1) (required for VA group only), then as-needed based on VA (RBZ-VA, n=106) or disease activity (RBZ-DA, n=116) criteria. In the vPDT arm, patients were treated on day 1 then received RBZ or vPDT after M3 based on disease activity (vPDT, n=55). The primary efficacy end point was mean average best-corrected visual acuity (BCVA) change from baseline to M1 through M3; superiority was achieved at the multiple one-sided alpha-level of 0.001. BCVA outcomes were assessed through M12.
RBZ treatment groups were significantly superior to the vPDT treatment group with respect to mean average BCVA change from baseline to M1 through M3 (RBZ-VA: +10.5, RBZ-DA: +10.6 ETDRS letters versus vPDT: +2.2 ETDRS letters; both P<0.00001). The mean BCVA change from baseline to M12 in the RBZ-VA, RBZ-DA, and vPDT with RBZ rescue injection arms was +13.8, +14.4, and +9.3 ETDRS letters, respectively. The median number of RBZ injections by M11 were 4.0 (RBZ-VA), 2.0 (RBZ-DA), and 2.0 (vPDT/RBZ). By M12, no deaths or endophthalmitis occurred in any treatment arm.
RBZ treatment guided by disease activity criteria or BCVA stability criteria was superior to vPDT for vision loss due to mCNV. Clinically significant BCVA gains were achieved and maintained through M12 with as-needed treatment in the RBZ-VA and RBZ-DA arms (median 2.0-4.0 number of RBZ injections through M12).
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.
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