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Risk factors for fellow eye treatment in protocol T

  • Retinal Disorders
  • Published:
Graefe's Archive for Clinical and Experimental Ophthalmology Aims and scope Submit manuscript

Abstract

Purpose

To identify risk factors for fellow eye treatment of diabetic retinopathy with Vascular Endothelial Growth Factor (VEGF) injections during the Diabetic Retinopathy Clinical Research Network (DRCR.Net) Protocol T trial

Methods

In this post-hoc analysis of randomized clinical trial data, Cox regression analysis was performed at 52 and 104 weeks to determine risk factors for treatment in 360 fellow eyes. Survival analysis was performed to determine mean time to treatment based upon medication used.

Results

Of 360 fellow eyes, 142 (39.4%) required treatment between weeks 4 and 104. Risk factors predicting a lower likelihood of year 1 treatment included older subject age (Hazard Ratio [HR]=0.98, 95% CI 0.96–0.99; p = 0.02) and higher baseline study eye ETDRS score (HR=0.98, 95% CI 0.97-0.99, p = 0.04). Center-involving DME at baseline in the fellow eye was predictive of a higher treatment need at both 52 (HR=1.89, 95% CI 1.42-2.51, p < 0.0001) and 104 weeks (HR=2.68, 95% CI 1.75-4.11, p < 0.0001). Subjects treated in the study eye with aflibercept (HR=0.574, 95% CI 0.371–0.887, p = 0.013) and ranibizumab (HR=0.58, 95%CI 0.36-0.94, p = 0.03) were less likely to require first year fellow eye injection than subjects treated with bevacizumab although this difference was no longer significant at week 104 (aflibercept HR=0.77, 95% CI 0.52–1.16, p = 0.21; ranibizumab HR=0.66, 95% CI 0.43–1.00, p = 0.05). Mean time to treatment was significantly shorter in the bevacizumab group (bevacizumab 25.83 weeks, aflibercept 38.75 weeks, ranibizumab 34.70 weeks (p=0.012)).

Conclusion

Bilateral treatment with intravitreal anti-VEGF injections was common during the DRCR.net Protocol T. Medication choice may impact the risk of fellow eye treatment.

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Data availability

The source of the data is the DRCR.net, but the analyses, content and conclusions presented herein are solely the responsibility of the authors and have not been reviewed or approved by the DRCR.net. The contents of this report do not represent the views of the United States Department of Veterans Affairs or the United States Government.

Materials availability

All data is available at https://public.jaeb.org/drcrnet/stdy

Code availability

Not applicable

Abbreviations

VEGF:

Vascular endothelial growth factor

DRCR.Net:

Diabetic retinopathy clinical research network

ETDRS:

Early treatment of diabetic retinopathy study

DME:

Diabetic macular edema

OCT:

Optical coherence tomography

CMT:

Central macular thickness

HbA1c:

Glycosylated hemoglobin

HTN:

Hypertension

MI:

Myocardial infarction

CAD:

Coronary artery disease

TIA:

Transient ischemic attack

CVA:

Cerebrovascular accident

PRP:

Panretinal photocoagulation

HR:

Hazard ratio

CI:

Confidence interval

PDR:

Proliferative diabetic retinopathy

NPDR:

Nonproliferative diabetic retinopathy

WESDR:

Wisconsin epidemiologic study of diabetic retinopathy

DM:

Diabetes mellitus

VA:

Visual acuity

DR:

Diabetic retinopathy

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Authors and Affiliations

  1. Department of Ophthalmology, Boston University School of Medicine, 85 East Concord Street, 8th floor, Boston, MA, 02118, USA

    Steven Ness, Michael Green, Dean Loporchio, Alexander D. Port, Xuejing Chen, Nicole H. Siegel & Manju L. Subramanian

  2. Veterans Affairs Boston Healthcare System, Jamaica Plain, Boston, MA, USA

    Steven Ness & Vasiliki Poulaki

Authors
  1. Steven Ness
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  2. Michael Green
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  3. Dean Loporchio
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  4. Alexander D. Port
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  5. Xuejing Chen
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  6. Nicole H. Siegel
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  7. Vasiliki Poulaki
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  8. Manju L. Subramanian
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Correspondence to Steven Ness.

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The Institutional Review Board of Boston University Medical Campus determined that approval was not required for this study.

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Ness, S., Green, M., Loporchio, D. et al. Risk factors for fellow eye treatment in protocol T. Graefes Arch Clin Exp Ophthalmol 259, 2203–2212 (2021). https://doi.org/10.1007/s00417-021-05108-0

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  • DOI: https://doi.org/10.1007/s00417-021-05108-0

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