Prospective Trial of Treat-and-Extend versus Monthly Dosing for Neovascular Age-Related Macular Degeneration: TREX-AMD 1-Year Results

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• 作者：Charles C. Wykoff ; MD ; PhD¹ ; ² ; ^{ccwmd@houstonretina.com" class="auth_mail" title="E-mail the corresponding author} ; Daniel E. Croft ; BA¹ ; David M. Brown ; MD¹ ; ² ; Rui Wang ; BA¹ ; John F. Payne ; MD³ ; Lloyd Clark ; MD³ ; Nizar Saleh Abdelfattah ; MD⁴ ; ⁵ ; SriniVas R. Sadda ; MD⁴ ; ⁵ ; on behalf of the TREX-AMD Study Group^&lowast ;
• 关键词：AMD ; age-related macular degeneration ; BCVA ; best-corrected visual acuity ; CRT ; central retinal thickness ; ETDRS ; Early Treatment Diabetic Retinopathy Study ; OCT ; optical coherence tomography ; PRN ; pro re nata ; SD ; spectral-domain ; TREX ; treat-and-extend ; VA ; visual acuity ; VEGF ; vascular endothelial growth factor
• 刊名：Ophthalmology
• 出版年：2015
• 出版时间：December 2015
• 年：2015
• 卷：122
• 期：12
• 页码：2514-2522
• 全文大小：1755 K

文摘

To assess prospectively a treat-and-extend (TREX) management strategy compared with monthly dosing of intravitreal ranibizumab in treatment-naïve neovascular age-related macular degeneration (AMD) patients.

Design

Phase IIIb, multicenter, randomized, controlled clinical trial.

Participants

Sixty patients with treatment-naïve neovascular AMD randomized 1:2 to monthly or TREX management.

Methods

Patients with Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) from 20/32 to 20/500 (Snellen equivalent) were randomized to receive intravitreal 0.5 mg ranibizumab monthly or according to a TREX protocol. The TREX patients were treated monthly for at least 3 doses, until resolution of clinical and spectral-domain optical coherence tomography evidence of exudative disease activity; the interval between visits then was individualized according to a strict prospective protocol.

Main Outcome Measures

Mean ETDRS BCVA change from baseline.

Results

At baseline, mean age was 77 years (range, 59–96 years), mean BCVA was 20/60 (Snellen equivalent), and mean central retinal thickness (CRT) was 511 μm. Fifty-seven eyes (95%) completed month 12, at which point mean BCVA improved by 9.2 and 10.5 letters in the monthly and TREX cohorts, respectively (P = 0.60). The mean number of injections administered through month 12 was 13.0 and 10.1 (range, 7–13) in the monthly and TREX cohorts, respectively (P < 0.0001). Among TREX patients, 7 (18%) were maximally extended, 4 (10%) demonstrated fluid at every visit, and at month 12, 18 (45%) had achieved an extension interval of 8 weeks or more; the mean maximum extension interval between injections after the first 3 monthly doses was 8.4 weeks (range, 4–12 weeks). Most TREX patients who demonstrated recurrent exudative disease activity (17/24 [71%]) were unable to extend beyond their initial maximum extension interval.

Conclusions

The TREX neovascular AMD management strategy used in this prospective, randomized, controlled trial resulted in visual and anatomic gains comparable with those obtained with monthly dosing.