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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.
SUBMITTER: Bressler NM
PROVIDER: S-EPMC6648655 | biostudies-literature | 2018 Nov
REPOSITORIES: biostudies-literature
Bressler Neil M NM Beaulieu Wesley T WT Maguire Maureen G MG Glassman Adam R AR Blinder Kevin J KJ Bressler Susan B SB Gonzalez Victor H VH Jampol Lee M LM Melia Michele M Sun Jennifer K JK Wells John A JA
American journal of ophthalmology 20180802
<h4>Purpose</h4>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.<h4>Design</h4>Randomized clinical trial.<h4>Methods</h4>Setting: Multicenter (89 U.S. sites).<h4>Patient population</h4>Eyes with VA and CST data from baseline and 12-week visits (616 of 660 eyes randomized [93.3%]).<h4>Intervention< ...[more]