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Sergio Pagliarini, Katja B Hatz, Philippe Margaron, Vladimir Bezlyak, Christine Thorburn; Similar two-year safety profiles of bilateral versus unilateral treatments with ranibizumab 0.5 mg in nAMD and DME. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):1510.
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Patients with neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME) often present with bilateral disease requiring treatment in both eyes. There are limited data available which compare the safety profile of unilateral treatment (UT) with anti-VEGF agents to that of bilateral treatment (BT). Therefore, we analyzed the differential 2-yr safety profiles of BT and UT patients in the observational EPICOHORT (nAMD) and the interventional RETAIN (DME; http://clinicaltrials.gov, NCT01171976, registered: 07-27-2010, trial start: 09-2010) studies that allowed for long-term bilateral ranibizumab 0.5 mg (RBZ) treatment (pro-re-nata or treat-and-extend).
Retrospective analysis of the 2-yr treatment exposure and safety profiles of RBZ in EPICOHORT (n=755) and RETAIN (n=370) patients (bilateral treatment administered at the investigator’s discretion). Treatment exposure was assessed by the mean injection number and interval between injections. The safety profiles included the proportions of patients with ocular and systemic adverse events (AE incidences) and AE types.
Overall, 18% (n=133) patients from EPICOHORT and 45% (n=166) patients from RETAIN received BT. The 2-yr RBZ exposure was higher in BT compared to UT patients; mean intervals between injections and numbers of injections (BT/UT): 20/41 days and 12.4/6.0 (nAMD), 11/26 days and 18.9/10.9 (DME), respectively. In contrast, the BT/UT safety profiles were similar for systemic AEs with overall AE incidences of 31.6/31.2% (nAMD) and 77.7/73.5% (DME). The 2-yr incidences of cerebrovascular thromboembolic events (BT/UT: 0.8/1.1% nAMD, 3.0/2.5% DME) and myocardial infarction (acute and non-acute; BT/UT: 0/0.6% nAMD, 1.8/2.5% DME) were comparable. Also, the overall BT/UT ocular AE incidences were similar in nAMD (39.1/34.1%) but higher in DME (65.1/47.5%) due to AEs associated with the injection procedure and complications related to diabetes (conjunctival hemorrhage, cataract, and worsening of retinal edema).
The analysis revealed similar systemic AE profiles of RBZ in BT and UT patients with nAMD and DME, indicating no clinical impact of bilateral treatment on systemic safety. Furthermore this analysis showed no unexpected increase in ocular AE incidences with BT compared with UT in patients with nAMD and DME.
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