Impact of Initial Monthly Doses of Aflibercept on Visual Outcomes in Eyes With Diabetic Macular Edema in Routine Clinical Practice in the US

Author Type(s)

Faculty

Document Type

Abstract

Publication Date

6-2023

Journal Title

Investigative Ophthalmology & Visual Science

Department

Ophthalmology

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.

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