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HORIZON Trial: As-needed therapy has similar safety profile as initial phase 3 trials
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SAN FRANCISCO — Ranibizumab therapy was well tolerated in patients dosed on an as-needed basis for 2 years after participating in phase 3 clinical trials, a speaker said here.
 Matthew S. Benz |
Rates of presumed endophthalmitis were low among patients in the HORIZON trial, with one case (rate, 0.05%) among 600 patients who received Lucentis (ranibizumab, Genentech) and 0 of 184 patients who were crossed over to ranibizumab therapy either during their initial trial (MARINA, ANCHOR or FOCUS) or during the PRN phase (HORIZON), Matthew S. Benz, MD, said during the joint meeting of the American Academy of Ophthalmology and the Pan-American Association of Ophthalmology. There were no cases in 69 untreated patients followed for a total of 4 years (original trial plus HORIZON), he said.
Rates of uveitis (0.09% treated, 0 cross-over and 0 untreated) and vitreous hemorrhage (0.05%, 0.13% and 0, respectively) were also low. Rates of vascular events and systemic events were similar in all three groups, Dr. Benz said.
Any intraocular inflammation occurred after injection in 0.06% of initially treated and 0.65% of cross-over patients. New cataract formation occurred in 3.47% of treated and 3.13% of cross-over patients.