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HARBOR 2-year results support individualized dosing
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TORONTO — Two-year results of the HARBOR trial support as-needed treatment in patients with wet age-related macular degeneration, a researcher said here.
“Over 2 years, 93% of PRN [as needed] patients did not require monthly dosing, indicating that an individualized treatment approach with ranibizumab may be appropriate for most patients with wet macular degeneration,” Brandon Busbee, MD, said at the American Society of Retina Specialists meeting.
Brandon Busbee
In the HARBOR trial, 1,097 patients with active disease were randomized to one of four groups: 0.5 mg or 2 mg ranibizumab injected monthly, or 0.5 mg or 2 mg ranibizumab given in three monthly loading doses, then given as needed thereafter. The primary endpoint was 12 months, but patients remained in their initial randomization category for an additional year.
At month 12, patients in the HARBOR trial had clinically meaningful gains in visual acuity, ranging from a mean of +8.6 letters in the 2 mg as-needed group to a mean of +10.1 letters in the 0.5 mg monthly group.
“In the second year, patients maintained their vision with an approximate loss of about 1 letter in most of the groups, with the exception of the 0.5 mg PRN group, which lost 0.3 letters,” Busbee said.
More than 30% of patients in all groups gained 15 or more letters in the first year of the study, Busbee said, with most groups increasing that percentage by the end of month 24.
For patients who completed year 2 in the 0.5 mg PRN arm of the study, the number of injections varied from three to 24, with a median of 14 injections.
“This data suggests that there was an individualized response in this cohort,” Busbee said. “The average treatment interval was 9.9 weeks after three loading doses.”
Disclosure: Busbee receives consulting, research and speaking support from Genentech and Regeneron.