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Factors Associated With Visual Acuity and Central Subfield Thickness Changes When Treating Diabetic Macular Edema With Anti-Vascular Endothelial Growth Factor Therapy: An Exploratory Analysis of the Protocol T Randomized Clinical Trial.
JAMA Ophthalmol. 2019 04 01; 137(4):382-389.JO

Abstract

Importance

Identifying the factors that are associated with the magnitude of treatment benefits from anti-vascular endothelial growth factor (anti-VEGF) therapy for diabetic macular edema (DME) may help refine treatment expectations.

Objective

To identify the baseline factors that are associated with vision and anatomic outcomes when managing DME with anti-VEGF and determine if there are interactions between factors and the agent administered.

Design, Setting, and Participants

This post hoc analysis of data from the Diabetic Retinopathy Clinical Research Network multicenter randomized clinical trial , Protocol T, was conducted between December 2016 and December 2017. Between August 22, 2012, and August 28, 2013, 660 participants were enrolled with central-involved DME and vision impairment (approximate Snellen equivalent, 20/32-20/320).

Interventions

Repeated 0.05-mL intravitreous injections of 2.0-mg aflibercept (201 eyes), 1.25-mg bevacizumab (185 eyes), or 0.3-mg ranibizumab (192 eyes) per protocol.

Main Outcomes and Measures

Change in visual acuity (VA) and optical coherence tomography (OCT) central subfield thickness at 2 years and change in VA over 2 years (area under the curve [AUC]).

Results

Among 578 participants, the median age (interquartile range) was 61 (54-67) years. Across anti-VEGF treatment groups, each baseline factor was associated with mean improvement in VA and a reduction in central DME compared with the baseline. For every decade of participant age, the mean VA improvement was reduced by 2.1 letters (95% CI, -3.0 to -1.2; P < .001) in the VA and 1.9 letters (95% CI, -2.4 to -1.3; P < .001) in the VA AUC analyses. For each 1% increase in hemoglobin A1c levels, VA improvement was reduced by 1 letter in the VA (95% CI, -1.5 to -0.5; P < .001) and 0.5 letters (95% CI, -0.9 to -0.2; P < .001) in the VA AUC analyses. Eyes with no prior panretinal photocoagulation (PRP) and less than severe nonproliferative diabetic retinopathy had an approximately 3-letter improvement in the VA (95% CI, 0.9-5.4; P = .007) and VA AUC (95% CI, 1.3-4.2; P < .001) analyses compared with eyes with prior PRP. On average, African American participants had greater reductions in central subfield thickness compared with eyes of white participants (-27.3 μm, P = .01), as did eyes with central subretinal fluid compared with eyes without this OCT feature (-22.9 μm, P = .01). There were no interactions between the predictive factors and the specific anti-VEGF agent that was administered for any VA or OCT outcome.

Conclusions and Relevance

Lower hemoglobin A1c levels were associated with the magnitude of vision improvement following anti-VEGF therapy, providing further evidence to encourage glycemic control among persons with diabetes. Younger patients and those without prior PRP might expect greater improvement in VA than older patients or those with prior PRP.

Authors+Show Affiliations

Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland.Jaeb Center for Health Research, Tampa, Florida.Department of Ophthalmology, University of Pennsylvania, Philadelphia.California Retina Consultants, Santa Barbara, California.Jaeb Center for Health Research, Tampa, Florida.Feinberg School of Medicine, Northwestern University Medical School, Chicago, Illinois.Southeast Retina Center, P.C., Augusta, Georgia.Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland.Joslin Diabetes Center, Beetham Eye Institute, Harvard Department of Ophthalmology, Boston, Massachusetts.No affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

30676635

Citation

Bressler, Susan B., et al. "Factors Associated With Visual Acuity and Central Subfield Thickness Changes when Treating Diabetic Macular Edema With Anti-Vascular Endothelial Growth Factor Therapy: an Exploratory Analysis of the Protocol T Randomized Clinical Trial." JAMA Ophthalmology, vol. 137, no. 4, 2019, pp. 382-389.
Bressler SB, Odia I, Maguire MG, et al. Factors Associated With Visual Acuity and Central Subfield Thickness Changes When Treating Diabetic Macular Edema With Anti-Vascular Endothelial Growth Factor Therapy: An Exploratory Analysis of the Protocol T Randomized Clinical Trial. JAMA Ophthalmol. 2019;137(4):382-389.
Bressler, S. B., Odia, I., Maguire, M. G., Dhoot, D. S., Glassman, A. R., Jampol, L. M., Marcus, D. M., Solomon, S. D., & Sun, J. K. (2019). Factors Associated With Visual Acuity and Central Subfield Thickness Changes When Treating Diabetic Macular Edema With Anti-Vascular Endothelial Growth Factor Therapy: An Exploratory Analysis of the Protocol T Randomized Clinical Trial. JAMA Ophthalmology, 137(4), 382-389. https://doi.org/10.1001/jamaophthalmol.2018.6786
Bressler SB, et al. Factors Associated With Visual Acuity and Central Subfield Thickness Changes when Treating Diabetic Macular Edema With Anti-Vascular Endothelial Growth Factor Therapy: an Exploratory Analysis of the Protocol T Randomized Clinical Trial. JAMA Ophthalmol. 2019 04 1;137(4):382-389. PubMed PMID: 30676635.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Factors Associated With Visual Acuity and Central Subfield Thickness Changes When Treating Diabetic Macular Edema With Anti-Vascular Endothelial Growth Factor Therapy: An Exploratory Analysis of the Protocol T Randomized Clinical Trial. AU - Bressler,Susan B, AU - Odia,Isoken, AU - Maguire,Maureen G, AU - Dhoot,Dilsher S, AU - Glassman,Adam R, AU - Jampol,Lee M, AU - Marcus,Dennis M, AU - Solomon,Sharon D, AU - Sun,Jennifer K, AU - ,, PY - 2019/1/25/pubmed PY - 2020/2/14/medline PY - 2019/1/25/entrez SP - 382 EP - 389 JF - JAMA ophthalmology JO - JAMA Ophthalmol VL - 137 IS - 4 N2 - Importance: Identifying the factors that are associated with the magnitude of treatment benefits from anti-vascular endothelial growth factor (anti-VEGF) therapy for diabetic macular edema (DME) may help refine treatment expectations. Objective: To identify the baseline factors that are associated with vision and anatomic outcomes when managing DME with anti-VEGF and determine if there are interactions between factors and the agent administered. Design, Setting, and Participants: This post hoc analysis of data from the Diabetic Retinopathy Clinical Research Network multicenter randomized clinical trial , Protocol T, was conducted between December 2016 and December 2017. Between August 22, 2012, and August 28, 2013, 660 participants were enrolled with central-involved DME and vision impairment (approximate Snellen equivalent, 20/32-20/320). Interventions: Repeated 0.05-mL intravitreous injections of 2.0-mg aflibercept (201 eyes), 1.25-mg bevacizumab (185 eyes), or 0.3-mg ranibizumab (192 eyes) per protocol. Main Outcomes and Measures: Change in visual acuity (VA) and optical coherence tomography (OCT) central subfield thickness at 2 years and change in VA over 2 years (area under the curve [AUC]). Results: Among 578 participants, the median age (interquartile range) was 61 (54-67) years. Across anti-VEGF treatment groups, each baseline factor was associated with mean improvement in VA and a reduction in central DME compared with the baseline. For every decade of participant age, the mean VA improvement was reduced by 2.1 letters (95% CI, -3.0 to -1.2; P < .001) in the VA and 1.9 letters (95% CI, -2.4 to -1.3; P < .001) in the VA AUC analyses. For each 1% increase in hemoglobin A1c levels, VA improvement was reduced by 1 letter in the VA (95% CI, -1.5 to -0.5; P < .001) and 0.5 letters (95% CI, -0.9 to -0.2; P < .001) in the VA AUC analyses. Eyes with no prior panretinal photocoagulation (PRP) and less than severe nonproliferative diabetic retinopathy had an approximately 3-letter improvement in the VA (95% CI, 0.9-5.4; P = .007) and VA AUC (95% CI, 1.3-4.2; P < .001) analyses compared with eyes with prior PRP. On average, African American participants had greater reductions in central subfield thickness compared with eyes of white participants (-27.3 μm, P = .01), as did eyes with central subretinal fluid compared with eyes without this OCT feature (-22.9 μm, P = .01). There were no interactions between the predictive factors and the specific anti-VEGF agent that was administered for any VA or OCT outcome. Conclusions and Relevance: Lower hemoglobin A1c levels were associated with the magnitude of vision improvement following anti-VEGF therapy, providing further evidence to encourage glycemic control among persons with diabetes. Younger patients and those without prior PRP might expect greater improvement in VA than older patients or those with prior PRP. SN - 2168-6173 UR - https://www.unboundmedicine.com/medline/citation/30676635/Factors_Associated_With_Visual_Acuity_and_Central_Subfield_Thickness_Changes_When_Treating_Diabetic_Macular_Edema_With_Anti_Vascular_Endothelial_Growth_Factor_Therapy:_An_Exploratory_Analysis_of_the_Protocol_T_Randomized_Clinical_Trial_ L2 - https://jamanetwork.com/journals/jamaophthalmology/fullarticle/10.1001/jamaophthalmol.2018.6786 DB - PRIME DP - Unbound Medicine ER -