Session Title: Vascular Diseases II
Session Date/Time: Friday 27/09/2013 | 11:00-12:30
Paper Time: 11:00
Venue: Hall F (Level 2)
First Author: U.Wolf-Schnurrbusch SWITZERLAND
The pivotal RADIANCE study was primarily designed to evaluate the efficacy and safety of two different regimens of ranibizumab 0.5 mg versus verteporfin photodynamic therapy (vPDT) in patients with visual impairment due to myopic choroidal neovascularization (mCNV), further analyses were performed to compare the changes in visual acuity (VA) across different CNV subtypes as well as the retinal anatomical responses in all treatment groups.
RADIANCE was a 12-month (M), phase III, randomized, double-masked, multicenter, active-controlled trial sponsored by Novartis.
Patients (N=277) were randomized 2:2:1 to Group 1 (G1; ranibizumab treatment guided by VA stability; n=106), G2 (ranibizumab treatment guided by disease activity; n=116) and G3 (vPDT and as of M3 then allowing ranibizumab/vPDT in the discretion of the investigators; n=55). The mean average change in best-corrected visual acuity (BCVA) from baseline to M1 through M3 was evaluated in a subgroup analysis by CNV type (subfoveal/juxtafoveal/extrafoveal) in each treatment group (G1: n=70/26/7; G2: n=81/24/3; G3 n=38/16/1, respectively). Also, the proportion of patients in each treatment group with absence of anatomical parameters such as intraretinal edema, subretinal fluid, and intraretinal cysts at Month 12 was assessed.
264 (96.4%) patients completed the study. Across all groups, the mean average change in BCVA scores from baseline to Month 1 through Month 3 improved in patients with different CNV subtypes(subfoveal/juxtafoveal/extrafoveal) as follows: G1: +11.2/+10.6/+6.9; G2: +11.2/+10.2/+4.0; G3: 2.1/+1.3/+19.0 Early Treatment Diabetic Retinopathy Study letters, respectively. In ranibizumab treated patients with subfoveal and juxtafoveal CNV lesions, numerically greater improvements in the mean average BCVA change were observed when compared with vPDT treated patients. In G3, the numerically greater improvement in mean average BCVA change in the subgroup with extrafoveal CNV might be unreliable as this subgroup consisted of one patient only. Considerable reductions in the proportion of patients with intraretinal edema from baseline to M12 were observed; in G1: from 84.8% to 2.9%, in G2: 79.3% to 4.3%, and in G3: 87.3% to 1.8%. Similarly, proportions with subretinal fluid were reduced from baseline to M12; in G1: from 35.2% to 3.8%, in G2: 40.5% to 4.3%, and in G3: 34.5% to 1.8%, and proportions of patients with intraretinal cysts decreased again from baseline to M12: in G1 from 27.6% to 14.3%, in G2: 27.6% to 15.5%, and in G3: 18.2% to 10.9%.
The subanalysis at Month 3 revealed consistent and greater improvements in visual acuity across all mCNV subtypes in response to ranibizumab than vPDT. In addition, patients in all treatment groups showed improvements in retinal anatomical outcomes; even in G3 after allowing ranibizumab 0.5 mg.