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Amelie Pielen, Julia Haller, GALILEO and COPERNICUS study investigators; Visual Acuity Outcomes in Dosing Subgroups of the GALILEO and COPERNICUS study in Patients With Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO) Under PRN Treatment. Invest. Ophthalmol. Vis. Sci. 2013;54(15):2827.
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Pharmacological agents that act against vascular endothelial growth factor (VEGF) have been shown to be effective treatments in the pathophysiology of macular edema secondary to CRVO. Monthly intravitreal delivery of aflibercept, a novel, anti-VEGF “trap” molecule, has been shown to treat macular edema and improve vision in CRVO patients. Here we present an integrated analysis evaluating BCVA outcomes by the number of intravitreal aflibercept injections (IAI) in patients who received pro re nata (PRN) dosing after 6 monthly doses in 2 clinical trials.
Two double-masked, multicenter, phase 3 trials (COPERNICUS and GALILEO) randomized patients to receive either IAI 2 mg or sham every 4 weeks up to Week 24. In both studies patients receiving fixed IAI until Week 24 were switched to PRN treatment with IAI from Weeks 24-52 (IAI 2q4-PRN). Number of injections ranged from 0 to 7. Integrated analysis was performed on BCVA outcomes in subgroups of patients receiving ≤3 and ≥4 injections after Week 24.
307 patients (198 received IAI; 109 received sham) completed Week 52. Of the patients who received IAI, 139 received ≤3 injections and 59 ≥4 injections. Baseline BCVA was 51.8 ± 15.0 letters in the ≤3 injections group and 51.9 ± 14.8 letters in the ≥4 injections group. The improvement achieved in BCVA at Week 24 after 6 monthly doses of was 18.8 ± 12.8 letters in the ≤3 injections group and 17.4 ± 11.2 letters in the ≥4 injections group. After 6 months with a PRN regimen and monthly monitoring, BCVA improvement showed a slight decrease of gain to 17.7 ± 16.6 letters in the ≤3 injections group and 16.7 ± 13.4 letters in the ≥4 injections group. In general AE frequency was rather similar between the 2 dosing subgroups with a few more injection related events in the group receiving 4 or more injections, the most frequent in both groups being conjunctival hemorrhage (≤3 injections: 5 cases [3.6%]; ≥4 injections: 7 cases [11.9%]).
These post-hoc analyses based on the numbers of injections administered in the second 6 months with monthly follow-up identified no added benefit of increased dosing in the PRN phase of pivotal studies. While gains achieved after 6 months of fixed dosing were largely maintained, both dosing subgroups showed a similar slight decrease of about 1 letter in BCVA.
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