Effect of Initial Aflibercept, Laser, or Observation on Low-Contrast Visual Acuity in Eyes With Diabetic Macular Edema and Good Vision: Ancillary Study Within a Randomized Clinical Trial

Wesley T Beaulieu; Adam R Glassman; Carl W Baker; Maureen G Maguire; Chris A Johnson; Michele Melia; Jennifer K Sun; DRCR Retina Network

doi:10.1167/tvst.10.3.3

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Effect of Initial Aflibercept, Laser, or Observation on Low-Contrast Visual Acuity in Eyes With Diabetic Macular Edema and Good Vision: Ancillary Study Within a Randomized Clinical Trial

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Effect of Initial Aflibercept, Laser, or Observation on Low-Contrast Visual Acuity in Eyes With Diabetic Macular Edema and Good Vision: Ancillary Study Within a Randomized Clinical Trial

Wesley T Beaulieu, Adam R Glassman, Carl W Baker, Maureen G Maguire, Chris A Johnson, Michele Melia, Jennifer K Sun and DRCR Retina Network

Translational vision science & technology, Vol.10(3), pp.3-12

03/01/2021

DOI: 10.1167/tvst.10.3.3

PMID: 34003937

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Abstract

To describe 2.5% low-contrast visual acuity (VA) among eyes with good vision despite center-involved diabetic macular edema and compare changes after initial management with aflibercept, laser, or observation. This was an ancillary study within a multicenter randomized clinical trial (DRCR Retina Network Protocol V). Participants had diabetes and 1 study eye with center-involved diabetic macular edema and a VA of 20/25 or better randomly assigned to aflibercept (n = 112), focal/grid laser (n = 146), or observation (n = 129). Eyes in the laser and observation groups received aflibercept if VA met prespecified worsening criteria. Participants had median age of 60 years, 37% were female and 70% were non-Hispanic White. At baseline, the mean ± standard deviation (SD) high-contrast VA was 85.2 ± 3.6 letters (Snellen equivalent 20/20), mean ± SD 2.5% low-contrast VA was 47.6 ± 18.9 letters (Snellen equivalent 20/125), and low-contrast VA letter score was 2 SDs or more below the age-specific normative values in 23%. At 2 years, the mean change ± SD in low-contrast VA in the aflibercept, laser, and observation groups was 2.7 ± 20.1, -2.0 ± 19.6, and -3.1 ± 20.8 letters (adjusted difference, aflibercept vs. laser, 5.3 [95% confidence interval, -0.2 to 10.8], P = 0.06; aflibercept vs. observation, 5.5 [95% confidence interval -0.2 to 11.2], P = 0.06; and laser vs. observation, 0.2 [95% confidence interval -4.6 to 5.0], P = 0.94). There was no significant difference between treatment groups in low-contrast VA change from baseline to 2 years. Considering the range of the 95% confidence intervals, however, the study may have been underpowered to detect a clinically meaningful benefit between treatment groups. Low-contrast VA, an important visual function, is decreased in eyes with diabetic macular edema.

Details

Title: Subtitle: Effect of Initial Aflibercept, Laser, or Observation on Low-Contrast Visual Acuity in Eyes With Diabetic Macular Edema and Good Vision: Ancillary Study Within a Randomized Clinical Trial
Creators: Wesley T Beaulieu - Jaeb Center for Health Research, Tampa, Florida, USA
Adam R Glassman - Jaeb Center for Health Research, Tampa, Florida, USA
Carl W Baker - Paducah Retinal Center, Paducah, Kentucky, USA
Maureen G Maguire - Department of Ophthalmology, University of Pennsylvania, Philadelphia, Pennsylvania, USA
Chris A Johnson - Department of Ophthalmology and Visual Sciences, University of Iowa, Iowa City, Iowa, USA
Michele Melia - Jaeb Center for Health Research, Tampa, Florida, USA
Jennifer K Sun - Joslin Diabetes Center, Beetham Eye Institute, Harvard Department of Ophthalmology, Boston, Massachusetts, USA
DRCR Retina Network
Resource Type: Journal article
Publication Details: Translational vision science & technology, Vol.10(3), pp.3-12
DOI: 10.1167/tvst.10.3.3
PMID: 34003937
NLM abbreviation: Transl Vis Sci Technol
ISSN: 2164-2591
eISSN: 2164-2591
Language: English
Date published: 03/01/2021
Academic Unit: Ophthalmology and Visual Sciences
Record Identifier: 9984101612702771

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