June 2023
Volume 64, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2023
Impact of initial monthly doses of aflibercept on visual outcomes in eyes with diabetic macular edema in routine clinical practice in the US
Author Affiliations & Notes
  • Nitish Mehta
    Department of Ophthalmology, NYU Langone Health, New York, New York, United States
  • Ferhina S. Ali
    Department of Ophthalmology, New York Medical College, Valhalla, New York, United States
  • Rishi Singh
    Center for Ophthalmic Bioinformatics, Cleveland Clinic Cole Eye Institute, Cleveland, Ohio, United States
  • Nick Boucher
    Vestrum Health, Naperville, Illinois, United States
  • Fabiana Q. Silva
    Regeneron Pharmaceuticals Inc, Tarrytown, New York, United States
  • Rutvi Desai
    Regeneron Pharmaceuticals Inc, Tarrytown, New York, United States
  • Steven Sherman
    Regeneron Pharmaceuticals Inc, Tarrytown, New York, United States
  • Footnotes
    Commercial Relationships   Nitish Mehta None; Ferhina Ali Allergan/AbbVie, EyePoint, Genentech , Code C (Consultant/Contractor); Rishi Singh Alcon, Bausch & Lomb, Genentech/Roche, Novartis, Regeneron Pharmaceuticals, Inc, Zeiss, Code C (Consultant/Contractor), Apellis, NGM Biopharma , Code F (Financial Support); Nick Boucher Vestrum Health, Code E (Employment); Fabiana Silva Regeneron Pharmaceuticals, Inc, Code E (Employment), Regeneron Pharmaceuticals, Inc, Code I (Personal Financial Interest); Rutvi Desai Regeneron Pharmaceuticals, Inc, Code E (Employment), Regeneron Pharmaceuticals, Inc, Code I (Personal Financial Interest); Steven Sherman Regeneron Pharmaceuticals, Inc, Code E (Employment), Regeneron Pharmaceuticals, Inc, Code I (Personal Financial Interest)
  • Footnotes
    Support  This study was funded by Regeneron Pharmaceuticals, Inc (Tarrytown, New York). The sponsor participated in the design and conduct of the study, analysis of the data, and preparation of this abstract.
Investigative Ophthalmology & Visual Science June 2023, Vol.64, 3646. doi:
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      Nitish Mehta, Ferhina S. Ali, Rishi Singh, Nick Boucher, Fabiana Q. Silva, Rutvi Desai, Steven Sherman; Impact of initial monthly doses of aflibercept on visual outcomes in eyes with diabetic macular edema in routine clinical practice in the US. Invest. Ophthalmol. Vis. Sci. 2023;64(8):3646.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : To evaluate the factors associated with initial monthly dosing of intravitreal aflibercept injections (IAI) and the impact on visual outcomes in patients with diabetic macular edema (DME).

Methods : This retrospective analysis assessed electronic medical records from a large US database (Vestrum Health) for eyes newly diagnosed with DME from January 2015 to June 2021 who received IAI as first-line anti-VEGF therapy and had ≥18 weeks of follow-up (initial monthly dosing period [IMDP]). Eyes that switched to another drug during the IMDP were excluded. Logistic regression was used to evaluate baseline (BL) factors predictive of receiving ≥4 injections in the IMDP, as well as of ≥5-, ≥10- or ≥15-letter gains at 12 months. IAI doses received during the IMDP were analyzed by tertiles (T1: 1-2; T2: 3; T3: ≥4 injections).

Results : A total of 23,962 eyes were included (T1, n=7781; T2, n=6922; T3, n=9259). BL factors predictive of receiving ≥4 injections (all P<0.05) during the IMDP included: type 2 diabetes vs type 1 diabetes, BL BCVA <20/40 vs ≥20/40, CST ≥300 µm vs <300 µm, presence of intraretinal fluid or subretinal fluid, DME and diabetic retinopathy (DR) diagnosed simultaneously at BL vs <1 year, and severe nonproliferative (NP) DR vs moderate NPDR (Table 1). Among a subset of 9457 eyes with VA data at 12 months (T1, n=2637; T2, n=2615; T3, n=4205), the proportions of eyes gaining ≥5-, ≥10- and ≥15-letters increased from T1 to T3. Predictors of ≥15-letter gains at 12 months (all P<0.05) included age <65 vs 75-79 years, BCVA <20/40 vs ≥20/40, receiving ≥4 vs 1-2 injections during the IMDP, post-IMDP injection count, and severe vs moderate NPDR (Table 2). Results for ≥5- and ≥10-letter gains were similar.

Conclusions : Several clinical and demographic factors were associated with receiving at least 4 IAI doses in the IMDP. In particular, eyes with baseline BCVA of <20/40 vs ≥20/40 were more likely to receive at least 4 injections. Among other factors, eyes receiving ≥4 vs 1-2 initial monthly doses were more likely to gain ≥5-, ≥10- and ≥15- letters at 12 months, suggesting that more frequent IAI treatment during IMDP may be beneficial.

This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.

 

Table 1. Baseline factors associated with receiving ≥4 IAI doses in the initial monthly dosing phase

Table 1. Baseline factors associated with receiving ≥4 IAI doses in the initial monthly dosing phase

 

Table 2. Factors associated with ≥15-letter gain at Month 12

Table 2. Factors associated with ≥15-letter gain at Month 12

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