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Randomized Controlled Trial
. 2018 Nov:195:93-100.
doi: 10.1016/j.ajo.2018.07.030. Epub 2018 Aug 2.

Early Response to Anti-Vascular Endothelial Growth Factor and Two-Year Outcomes Among Eyes With Diabetic Macular Edema in Protocol T

Neil M Bressler  1 , Wesley T Beaulieu  2 , Maureen G Maguire  3 , Adam R Glassman  4 , Kevin J Blinder  5 , Susan B Bressler  1 , Victor H Gonzalez  6 , Lee M Jampol  7 , Michele Melia  4 , Jennifer K Sun  8 , John A Wells 3rd  9 ; Diabetic Retinopathy Clinical Research Network
Affiliations
Randomized Controlled Trial

Early Response to Anti-Vascular Endothelial Growth Factor and Two-Year Outcomes Among Eyes With Diabetic Macular Edema in Protocol T

Neil M Bressler et al. Am J Ophthalmol. 2018 Nov.

Abstract

Purpose: Assess associations of 2-year visual acuity (VA) outcomes with VA and optical coherence tomography central subfield thickness (CST) after 12 weeks of anti-vascular endothelial growth factor treatment for diabetic macular edema in DRCR.net Protocol T.

Design: Randomized clinical trial.

Methods: Setting: Multicenter (89 U.S. sites).

Patient population: Eyes with VA and CST data from baseline and 12-week visits (616 of 660 eyes randomized [93.3%]).

Intervention: Six monthly injections of 2.0 mg aflibercept, 1.25 mg bevacizumab, or 0.3 mg ranibizumab; subsequent injections and focal/grid laser as needed for stability.

Main outcome measures: Change in VA from baseline and VA letter score at 2 years.

Results: Twelve-week VA response was associated with 2-year change in VA and 2-year VA letter score for each drug (P < .001) but with substantial individual variability (multivariable R2 = 0.38, 0.29, and 0.26 for 2-year change with aflibercept, bevacizumab, and ranibizumab, respectively). Among eyes with less than 5-letter gain at 12 weeks, the percentages of eyes gaining 10 or more letters from baseline at 2 years were 42% (20 of 48), 31% (21 of 68), and 47% (28 of 59), and median 2-year VA was 20/32, 20/32, and 20/25, in the aflibercept, bevacizumab, and ranibizumab groups, respectively. Twelve-week CST response was not strongly associated with 2-year outcomes.

Conclusions: A suboptimal response at 12 weeks did not preclude meaningful vision improvement (ie, ≥ 10-letter gain) in many eyes at 2 years. Eyes with less than 5-letter gain at 12 weeks often had good VA at 2 years without switching therapies.

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Figures

Figure 1
Figure 1. Change in Visual Acuity from Baseline by Early (12-Week) Visual Acuity Response and Anti-Vascular Endothelial Growth Factor Treatment Group.
Mean change in visual acuity letter score from baseline over 2 years by treatment group and 12-week visual acuity response. Error bars represent 95% confidence intervals.
Figure 2
Figure 2. Change in Visual Acuity from Baseline at 1 and 2 Years by Early (12-Week) Visual Acuity Response and Anti-Vascular Endothelial Growth Factor Treatment Group.
Change in visual acuity letter score from baseline at 1 (top left, top right) and 2 years (bottom left, bottom right) for eyes gaining fewer than 5 (top left, bottom left) and 10 or more letters (top right, bottom right) at 12 weeks.
Figure 3
Figure 3. Change in Visual Acuity from 12 Weeks at 1 and 2 Years by Early (12-Week) Visual Acuity Response and Anti-Vascular Endothelial Growth Factor Treatment Group.
Change in visual acuity letter score from 12 weeks at 1 (top left, top right) and 2 years (bottom left, bottom right) for eyes gaining fewer than 5 (top left, bottom left) and 10 or more letters (top right, bottom right) at 12 weeks.
See this image and copyright information in PMC

References

    1. Nguyen QD, Brown DM, Marcus DM, et al. Ranibizumab for diabetic macular edema: Results from 2 phase III randomized trials: RISE and RIDE. Ophthalmology 2012;119:789–801. - PubMed
    1. Diabetic Retinopathy Clinical Research Network, Wells JA, Glassman AR, et al. Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema. N Engl J Med 2015;372:1193–203. - PMC - PubMed
    1. Wells JA, Glassman AR, Ayala AR, et al. Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema: two-year results from a comparative effectiveness randomized clinical trial. Ophthalmology 2016;123:1351–9. - PMC - PubMed
    1. Brown DM, Schmidt-Erfurth U, Do DV, et al. Intravitreal aflibercept for diabetic macular edema: 100-week results from the VISTA and VIVID studies. Ophthalmology 2015;122:2044–52. - PubMed
    1. Bressler NM, Beaulieu WT, Glassman AR, et al. Persistent macular thickening following intravitreous aflibercept, bevacizumab, or ranibizumab for central-involved diabetic macular edema with vision impairment: A secondary analysis of a randomized clinical trial. JAMA Ophthalmol 2018;136:257–69. - PMC - PubMed

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