HARBOR study shows similar results for four anti-VEGF dosing regimens

BALTIMORE — Four dosing regimens of ranibizumab yielded similar safety and efficacy, with few ocular and systemic adverse events, a speaker said here.

“This is significant and clinically meaningful in terms of performance of treatment within all four arms,” Carl D. Regillo, MD, OSN Retina/Vitreous Board Member, said at Macula 2013.

Carl D. Regillo

The HARBOR study, a prospective, randomized trial, comprised four arms: 0.5-mg Lucentis (ranibizumab, Genentech) monthly (276 patients), 0.5-mg ranibizumab as needed (275 patients), 2-mg ranibizumab monthly (274 patients) and 2-mg ranibizumab as needed (273 patients).

The primary endpoints were safety and efficacy at 6 months; the secondary endpoints were safety and efficacy at 24 months.

Study results showed that patients in the 0.5-mg monthly dosing group received a mean 11.3 injections at 12 months and 21.4 injections at 24 months. Patients in the 0.5-mg as-needed dosing group received a mean 7.7 injections at 12 months and 10.4 injections at 24 months.

Patients in the 2-mg monthly dosing group received 11.2 injections at 12 months and 21.6 injections at 24 months. Those in the 2-mg as-needed dosing group received 6.9 injections at 12 months and 11.2 injections at 24 months.

All four groups had similar changes in central foveal thickness and gains in best corrected visual acuity at 24 months. The 0.5-mg as-needed dosing group gained a mean 7.9 letters at 24 months, Regillo said.

Disclosure: Regillo is a consultant for and has received research funding from Genentech, GSK, QLT and Regeneron.