Dataset Information

Prospective, Single-Center, Six-Month Study of Intravitreal Ranibizumab for Macular Edema with Nonproliferative Diabetic Retinopathy: Effects on Microaneurysm Turnover and Non-Perfused Retinal Area.

ABSTRACT: Purpose:To analyze the effects on microaneurysm (MA) and perifoveal perfusion in nonproliferative diabetic retinopathy (NPDR) patients with macular edema (ME) after early intensive treatment using intravitreal ranibizumab (IVR) injections. Patients and Methods:Prospectively, 25 eyes of 25 type 2 diabetes mellitus patients with ME were included between August 2016 and February 2019. For 6 months, patients were administered 0.5-mg IVR injections monthly. Ocular evaluation, including best-corrected visual acuity (BCVA; using the Early Treatment Diabetic Retinopathy Study chart), central retinal thickness (CRT; using optical coherence tomography), fundus photography, and fluorescein angiography, was performed for all participants. Results obtained at baseline were compared to those observed after 6 months. Results:Mean BCVA increased significantly from 67.6±3.29 letters at baseline to 76.36±1.61 letters after 6 months (P=0.002) of IVR therapy. CRT decreased significantly from 479.12±16.66 µm at baseline to 369.12±13.02 µm at 6 months. Similarly, the total number of MAs decreased significantly from 5.68±3.41 to 1.60±1.73 (P<0.0001). MA turnover, calculated by adding the MA formation rate to the MA disappearance rate (both calculated as MA number/month) also decreased significantly from 6.88±3.83 to 1.92±1.75 after treatment (P<0.0001). Perifoveal non-perfused area decreased from 2.517±0.456 mm2 at baseline to 2.495±0.293 mm2 at 6 months, but the results were not statistically significant (P=0.954). Conclusion:Treatment with early intensive IVR therapy in NPDR patients with ME not only improved BCVA and CRT but also decreased MA turnover. However, in the study period of 6 months, IVR therapy did not show significant improvement in perifoveal non-perfused area.

SUBMITTER: Lee SJ

PROVIDER: S-EPMC7305822 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Prospective, Single-Center, Six-Month Study of Intravitreal Ranibizumab for Macular Edema with Nonproliferative Diabetic Retinopathy: Effects on Microaneurysm Turnover and Non-Perfused Retinal Area.

Lee Seung Joon SJ Shin In Choel IC Jeong Il Won IW Choi Chang Wook CW Yang Yun Sik YS

Clinical ophthalmology (Auckland, N.Z.) 20200616

<h4>Purpose</h4>To analyze the effects on microaneurysm (MA) and perifoveal perfusion in nonproliferative diabetic retinopathy (NPDR) patients with macular edema (ME) after early intensive treatment using intravitreal ranibizumab (IVR) injections.<h4>Patients and methods</h4>Prospectively, 25 eyes of 25 type 2 diabetes mellitus patients with ME were included between August 2016 and February 2019. For 6 months, patients were administered 0.5-mg IVR injections monthly. Ocular evaluation, including ...[more]

PMID: 32606576

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Project description:PurposeThis retrospective study aimed to compare the efficacy of intravitreal ranibizumab (IVR) and intravitreal dexamethasone implant (IDI) for pseudophakic vitrectomized eyes with diabetic macular edema (DME) in a single institution.MethodsPseudophakic vitrectomized eyes with treatment-naïve center-involved DME were enrolled, with one eye in each patient. They were divided into two groups: one group receiving IDI every 3 to 4 months and another group receiving IVR using 3 monthly plus treat-and-extend injections, all with monthly follow-up for 6 months. Switch of intravitreal drugs or deferred macular laser was not allowed. Primary outcome measures included change in central foveal thickness (CFT) in 1 mm by spectral-domain optical coherence tomography and best-corrected visual acuity (BCVA) at Month 6.ResultsTwenty-two eyes were included in the IDI group and 26 eyes in the IVR group. The baseline demographics, glycosylated hemoglobin level, intraocular pressure (IOP), BCVA, and CFT did not significantly differ (p > 0.05). Compared to baseline data, CFT decreased and BCVA improved significantly after either IDI or IVR at Month 6 (p < 0.05). Significantly better mean final BCVA (0.38 logMAR vs. 0.62 logMAR, p=0.04), more mean visual gain (-0.30 logMAR vs. -0.15 logMAR, p=0.02), lower mean final CFT (310.9 μm vs. 384.2 μm, p=0.04), and larger mean CFT decrease (-150.0 μm vs. -60.1 μm, p=0.03) were found in the IDI group compared to those in the IVR group. A smaller mean treatment number (2.6 vs. 5.6, p < 0.001) and higher rate of postinjection ocular hypertension requiring topical hypotensive agent therapy (27.3% vs. 0%, p=0.0002) were demonstrated in the IDI group than those in the IVR group.ConclusionWe concluded that IDI and IVR can both effectively treat vitrectomized eyes with DME. Dexamethasone implants had significantly better visual/anatomical improvement, smaller treatment number, and higher rate of elevated IOP after injection than IVR in pseudophakic vitrectomized eyes with DME in a 6-month period.

Project description:Variability in response to anti-vascular endothelial growth factor (VEGF) treatment in diabetic macular edema (DME) remains a significant clinical challenge. Biomarkers could help anticipate responses to anti-VEGF therapy.To investigate aqueous humor cytokine level changes in response to intravitreal ranibizumab therapy for the management of DME, and to determine the association between baseline aqueous levels and anatomic response.In this prospective multicenter cohort study, 49 participants with diabetes mellitus complicated by center-involving DME, with a central subfield thickness of 310 μm or greater on spectral-domain optical coherence tomography (SD-OCT), were recruited from December 22, 2011, to June 13, 2013 and statistical analysis were performed from March 1, 2017, to June 1, 2017. A total of 48 participants proceeded to follow-up.Participants received monthly injections of ranibizumab, 0.5 mg, for 3 months. Aqueous fluid for cytokine analysis was obtained at baseline and repeated at the 2-month visit. Multiplex immunoassay was carried out in duplicate for VEGF, placental growth factor, transforming growth factor beta 2, intercellular adhesion molecule 1 (ICAM-1), interleukin 6 (IL-6), IL-8, IL-10, vascular intercellular adhesion molecule, and monocyte chemoattractant protein 1.Baseline and 2-month change in aqueous cytokine levels, 3-month change in SD-OCT central subfield thickness and macular volume (MV), and the statistical association between baseline aqueous cytokine levels and these measures of anatomic response to ranibizumab in center-involving DME.Among the 48 participants, the mean (SD) age was 61.9 (7.1) years and 36 participants (75.0%) were men. The following cytokines were lower at month 2 vs baseline: ICAM-1 (median change, -190.88; interquartile range [IQR], -634.20 to -26.54; P < .001), VEGF (median change, -639.45; IQR, -1040.61 to -502.61; P < .001), placental growth factor (median change, -1.31; IQR, -5.99 to -0.01; P < .001), IL-6 (median change, -38.61; IQR, -166.72 to -2.80; P < .001), and monocyte chemoattractant protein 1 (median change, -90.13; IQR, -382.74 to 109.47; P = .01). When controlling for age, foveal avascular zone size, and severity of retinopathy, multiple linear regression determined that increasing baseline aqueous ICAM-1 was associated with a favorable anatomic response, in terms of reduced SD-OCT MV at 3 months (every additional 100 pg/mL of baseline ICAM-1 was associated with a reduction of 0.0379 mm3; P = .01). Conversely, increasing baseline aqueous VEGF was associated with a less favorable SD-OCT MV response at 3 months (every additional 100 pg/mL of baseline VEGF was associated with an increase of 0.0731 mm3; P = .02) and was associated with lower odds of being a central subfield thickness responder (odds ratio, 0.868; 95% CI, 0.755-0.998).Elevated aqueous ICAM-1 and reduced VEGF levels at baseline are associated with a favorable anatomic response to ranibizumab in DME, although there is not always direct correlation between anatomic and visual acuity response.

Dataset Information

Prospective, Single-Center, Six-Month Study of Intravitreal Ranibizumab for Macular Edema with Nonproliferative Diabetic Retinopathy: Effects on Microaneurysm Turnover and Non-Perfused Retinal Area.

Publications

Prospective, Single-Center, Six-Month Study of Intravitreal Ranibizumab for Macular Edema with Nonproliferative Diabetic Retinopathy: Effects on Microaneurysm Turnover and Non-Perfused Retinal Area.

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