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Victor Chong, Winfried Amoaku, Jonathan Alsop, Aaron Osborne; Effectiveness of quarterly (Q3M) versus monthly (QM) ranibizumab according to initial gains in visual acuity - an analysis of 12 month data from the EXCITE study. Invest. Ophthalmol. Vis. Sci. 2013;54(15):3816.
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© ARVO (1962-2015); The Authors (2016-present)
To investigate whether early visual acuity (VA) response to ranibizumab treatment in patients with neovascular AMD (nAMD) is predictive of VA outcomes at one year; and to to identify cohorts of patients (pts) in whom Q3M or more frequent follow-up may be required.
EXCITE was a 12-month, multicenter, double-masked, phase IIIb study of patients (N=353) with primary or recurrent nAMD (all lesion types) randomized 1:1:1 to treatment with three monthly initiating injections followed by 9 months of either 0.3 mg or 0.5 mg Q3M, or 0.3 mg QM ranibizumab. In this post-hoc analysis pts were categorized according to one of four VA response groups (those who: gained ≥15 letters [Cat 1]; gained 5-14 letters [Cat 2]; gained <5 and lost ≤ 5 letters) [Cat 3]; lost >5 letters [Cat 4]) according to change in best-corrected VA (BCVA [ETDRS]) from baseline to Month 3. Mean BCVA outcomes at Month 12 were compared between combined quarterly and monthly dosing groups using a linear regression model adjusted for Month 3 BCVA.
In Cat 1 pts (n=49), there was no difference in the efficacy of QM (n=19) and Q3M (n=30) dosing of ranibizumab at Month 12 (BCVA +0.6 and -0.7 letters respectively; p=0.577 [linear regression adjusted for Month 3 BCVA]). This was also evident in Cat 3 pts (n=118) (BCVA +0.11 [n=35] and -0.75 [n=83] respectively; p=0.523), but not in Cat 2 pts (n=147) (Month 12 BCVA +1.65, n=49; and -3.17, n=98 respectively; p=0.0027). In Cat 4 pts (n=24), QM dosing at Month 12 was significantly more effective than Q3M (BCVA +0.30 [n=10] versus -9.79 [n=14] respectively; p=0.037).
In EXCITE, QM treatment was superior to Q3M treatment; however, VA gains at month 3 were maintained in most pts with Q3M treatment. Eyes that have a strong early response to ranibizumab (≥15 letter gained) may require only Q3M treatment/monitoring. Eyes with initial loss of VA may require more intensive monitoring and treatment. These data suggest additional options for individualizing pt care in AMD.
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