Baseline Ocular Characteristics of Patients Undergoing Initiation of Anti-Vascular Endothelial Growth Factor Therapy for Diabetic Macular Edema.

BACKGROUND AND OBJECTIVES: Patients with diabetic macular edema (DME) have variable anatomic and visual responses to anti-vascular endothelial growth (VEGF) treatments based on their presenting visual acuity (VA). The aim of study is to report the baseline ocular and imaging characteristics of patients presenting with DME who were treatment-naïve and who initiated anti-VEGF in routine clinical practice. PATIENTS AND METHODS: Single-center, cross-sectional study of 638 patients. Subjects were divided into two VA groups: Early Treatment Diabetic Retinopathy Study (ETDRS) less than 70 and ETDRS greater than 70 and ocular variables were compared between groups. RESULTS: Average central subfield thickness (CST) was 363.5 µm, cube volume was 11.7 mm3, and cube average thickness (CAT) was 326.1 µm. Additionally, 21.5% had subretinal fluid (SRF), and 50.5% had hard exudates on presentation. Eyes with ETDRS less than 70 had greater CAT (338.5 µm3 vs. 313.2 µm3; P < .001), greater cube volume (12.2 mm3 vs. 11.3 mm3; P < .001), greater CST (383.5 µm vs. 350.0 µm; P < .001), and SRF (25.5% vs. 17.3%; P = .012). Furthermore, 7.64% had glaucoma, 1.3% had dry age-related macular degeneration, 4.5% of patients were vitrectomized, and 28.7% were pseudophakic. Regarding diabetic stage, 37% had proliferative diabetic retinopathy (PDR) and 63% presented with nonproliferative diabetic retinopathy. Patients presenting with ETDRS less than 70 were more likely to have a history of vitrectomy (7.1% vs. 1.9%, P = .002) and presence of PDR (42.3% vs. 31.4%, P = .004). CONCLUSION: The results describe a population of patients from a routine clinical practice not entirely represented in clinical trials, with key differences in ocular characteristics seen between VA groups. [Ophthalmic Surg Lasers Imaging Retina. 2019;50:69-75.].

Characterization of the Systemic Findings of Patients Undergoing Initiation of Anti-Vascular Endothelial Growth Factor Therapy for Diabetic Macular Edema in Routine Clinical Practice.

BACKGROUND AND OBJECTIVES: Previous studies have validated that baseline visual acuity (VA) can predict a variance response to anti-vascular endothelial growth factor (VEGF) treatment. However, little is known about the initial systemic presentation of diabetic macular edema (DME) in clinical practice. The aim of this study is to report the baseline systemic findings of patients presenting with DME who received anti-VEGF in clinical practice. PATIENTS AND METHODS: A retrospective chart review of patients with DME presenting between April 2012 and December 2016 was performed. RESULTS: Data from 638 patients were retrieved. The average patient age was 63.1 years (±11.6 years), and 53% were male. There were 95.6% type II diabetics with an average HgA1c of 8.1% (range: 5.1% to 14.5%). Insulin use was present in 67%, biguanides in 43%, sulfonylureas in 32.8%, DDP4 inhibitors in 11.8%, thiazolidinediones in 3.9%, and D-phenylalanine derivatives in 0.94%. Hypertension was present in 78.4% of patients, cardiac comorbidities in 29.3%, peripheral vascular disease in 16.5%, and renal insufficiency in 22.6%. Patients were then split into two different cohorts based on VA (ETDRS < 70 and ETDRS ≥ 70), and variables were compared between groups. CONCLUSION: It was shown that older age, hypertension, elevated creatinine, elevated high-density lipoprotein cholesterol, and decreased biguanide use were positively associated with worse presenting VA. [Ophthalmic Surg Lasers Imaging Retina. 2019;50:16-24.].

An International Comparison of Baseline Characteristics of Patients Undergoing Initiation of Anti-VEGF Therapy for DME.

BACKGROUND AND OBJECTIVE: Diabetic macular edema (DME) is a leading cause of vision loss worldwide. The object of this study is to compare global differences of baseline characteristics of patients undergoing initiation of anti-vascular endothelial growth factor (VEGF) therapy for DME. PATIENTS AND METHODS: This multicenter, cross-sectional study included diabetic patients with foveal-involving retinal edema secondary to DME as documented by fundus exam and optical coherence tomography who were undergoing initiation of intravitreal anti-VEGF drugs. Variables were collected to find possible risk factors and to create an epidemiological profile of DME patients undergoing initiation of anti-VEGF agents. RESULTS: Nine hundred two patients were selected. Mean age was 62.4 (±11) years, 49.7% were Caucasians, 57.6% were male, and 96% had type two diabetes with an average disease duration of 181.7 months ± 113 months. Of the patients included, 74.7% suffered from hypertension, 26.6% from cardiovascular disease, 12.1% from cerebrovascular disease, 12.8% from peripheral vascular disease, and 12.8% from renal insufficiency. Best-corrected visual acuity (BCVA) was 65 (±20) Early Treatment Diabetic Retinopathy Study letters, central subfield thickness was 364 (±162) µm, cube volume 11.1 ± 3.1 mm3, cube average thickness 328.8 µm ± 61 µm, and 63.9% had nonproliferative diabetic retinopathy. Comparison between U.S. versus international patients, and patients with BCVA 70 letters or less versus more than 70 letters were performed, significant differences were acknowledged, and risk factors were recognized. CONCLUSION: There were key differences in the epidemiologic profile between patients presenting with DME in the U.S. and internationally. [Ophthalmic Surg Lasers Imaging Retina. 2019;50:e300-e310.].