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Charles Clifton Wykoff, David M Brown, Daniel Croft, Rui Wang, Lloyd Clark, John F. Payne, TREX-AMD; Multicenter, Prospective Trial Comparing Treat & Extend to Monthly Dosing in Neovascular AMD Management: TREX-AMD 12-Month Outcomes. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):5371.
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To prospectively assess a treat and extend (TREX) management strategy compared to monthly dosing with intravitreal ranibizumab in neovascular age-related macular degeneration (AMD).
Treatment naïve patients (n=60) with ETDRS BCVA of 20/32-20/400 (Snellen equivalent) were randomized 1:2 to receive intravitreal 0.5mg ranibizumab monthly or according to a TREX protocol. TREX patients were treated monthly (at least 3 doses), until resolution of clinical and spectral-domain-OCT evidence of exudative disease activity; the interval between visits was subsequently increased by 2-week intervals to a maximum of 12-weeks and patients were treated at every study visit. Upon recurrent exudative disease activity, the interval was individualized as tolerated. Primary outcome was mean change in BCVA. Secondary outcomes included mean change in central retinal thickness (CRT), number of treatments and percentage of patients gaining or losing 10 ETDRS letters.
At baseline mean age was 77 years (range 59-96), mean Snellen equivalent BCVA was 20/60 and mean CRT was 511um. Forty-nine eyes (82%) complete month 12 (M12). Mean BCVA improved from baseline to M12 by 9.2 and 7.2 letters in the monthly and TREX arms respectively (P= 1.32x10-5 and P=6.19x10-3 for each group and P=0.60 between groups). Mean CRT improved from baseline to M12 by 236um and 196um in the monthly and TREX arms (P=1.33x10-4 and P=3.04x10-6 for each group and P=0.11 between groups). Mean number of injections administered through M12 was 13.0 and 10.0 (range 7-13) in the monthly and TREX arms. At M12, 9 and 10 patients gained 10 or more letters in the monthly and TREX arms respectively. At M12, 0 and 2 patients lost 10 letters in the monthly and TREX arms respectively. Among TREX patients, 7 (18%) remained dry after the initial 3 monthly doses and 6 (15%) were maximally extended while 3 (8%) remained wet at every visit; the mean maximum extension interval between injections after the first 3 monthly doses was 8.5 weeks (range 4-12 weeks).
The treat and extend neovascular AMD management strategy employed in this prospective, randomized, controlled clinical trial resulted in visual and anatomic gains comparable to those obtained with monthly dosing.
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