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Seenu M Hariprasad, Linda Yau, Gary Sternberg, SHORE Study Group; Effect of Alternate Ranibizumab Dosing Regimens on Visual and Anatomic Outcomes in Patients with Retinal Vein Occlusion - The SHORE study. Invest. Ophthalmol. Vis. Sci. 2014;55(13):3889.
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The SHORE study evaluated whether as-needed (PRN) treatment with ranibizumab (RBZ) in patients with retinal vein occlusion (RVO), after reaching a stable disease state, provides visual acuity (VA) gains comparable to monthly dosing over 15 months.
This 15-month, phase IV, randomized study enrolled a total of 202 eligible patients with branch RVO (BRVO, N=115) and central RVO (CRVO, N=87). From Months (M) 0-6, patients received 7 monthly RBZ 0.5 mg injections, and, between M7 and M14, continued to receive monthly RBZ injections until the first month at which pre-specified VA and spectral-domain OCT (SD-OCT) stability criteria were met. Patients were then randomized 1:1 to continue RBZ monthly (N=85) or switch to a PRN regimen (N=86). Non-randomized patients (N=31; ie, those who completed the study but did not meet stability criteria at any visit from M7 to M14, or those who discontinued either prior to M7 or prior to achieving disease stability) continued to receive monthly injections. The primary efficacy analysis compared the slope of the BCVA change from baseline curves from M7 to M15 between the PRN and monthly arms.
Approximately 80% of patients were randomized by M8. There was no significant difference in the slopes of the BCVA change from baseline between M7 to M15 between the monthly and PRN arms. The mean BCVA change from baseline at M15 were +21.0 (PRN arm) and +18.7 (monthly arm) letters. At M15, 70.7% and 66.3% of PRN- and monthly-treated patients gained ≥15 letters from baseline, respectively, and 76.8% and 71.3% of these patients achieved a Snellen equivalent of 20/40 or better, respectively. VA gains of +20.6 (BRVO) and +18.0 (CRVO) letters were highly clinically meaningful. Mean CFT change from baseline at M15 was -247.8 µm (PRN arm) and -289.9 µm (monthly arm). The PRN group received a mean of 3.7 injections between M7 and M14. Ocular and systemic safety profiles over 15 months were generally balanced between the PRN and monthly arms, with no dose exposure trends observed.
PRN treatment with RBZ in RVO (BRVO and CRVO patients), after reaching a stable disease state, provided VA gains comparable to monthly dosing over 15 months. Both the PRN and monthly groups demonstrated rapid and clinically meaningful reductions in CFT on SD-OCT throughout the study. Safety was consistent with previous RBZ studies in RVO.
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