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Extension trial suggests long-term tolerability of anti-VEGF
Ophthalmology. 2012;doi:10.1016/j.ophtha.2011.12.016.
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An extension trial suggested that multiple injections of ranibizumab may be well tolerated for more than 4 years, with less frequent treatment leading to decreased visual gain.
HORIZON, an open-label, multicenter, extension trial that included patients who completed the MARINA, ANCHOR or FOCUS trial through month 24, primarily assessed adverse events associated with 0.5 mg Lucentis (ranibizumab, Genentech).
Separate analyses were conducted for 600 patients who were initially treated with ranibizumab, 190 patients who were randomized to control and then switched over to ranibizumab, and 63 treatment-naïve patients.
Mild endophthalmitis occurred in one out of 3,552 HORIZON injections in those treated with ranibizumab, and no serious adverse events, specifically lens damage, retinal tear or rhegmatogenous retinal detachment, occurred. The proportion of patients with IOP of 30 mm Hg or greater was 9.2% in the ranibizumab treated-initial group, 6.6% in the ranibizumab crossover group and 0% in the untreated group; rates of glaucoma were 3.2%, 4.2% and 3.2%, respectively.
At month 48, after 2 years in the HORIZON trial, mean change in best corrected visual acuity relative to baseline was 2.0 letters in the ranibizumab treated-initial group, with a loss of 11.8 letters in the other two groups combined.
The trial authors noted that patients may have been significantly undertreated and that initial trial outcomes may have affected enrollment in the extension analysis, potentially causing bias. Another limitation was the possibility that rate of early discontinuation may have been affected by commercial availability of ranibizumab after U.S. Food and Drug Administration approval in 2006.