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Rachel Vatsal Thakore, Paul B Greenberg; Initiating Anti-VEGF Therapy for Diabetic Macular Edema: An Evidence-Based Guide . Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):1771.
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The varying (a) definitions of optical coherence tomography (OCT)-defined diabetic macular edema (DME) and best corrected visual acuity (VA), (b) patient characteristics and (c) main outcomes in randomized controlled trials (RCTs) can make it challenging to apply evidence-based practices for initiating anti-vascular endothelial growth factor (VEGF) therapy for DME. We analyzed phase III RCTs to formulate a template for clinicians starting anti-VEGF therapy for DME.
We searched for double-blind phase III RCTs for anti-VEGF therapy on clinicaltrials.gov prior to October 2014 using "diabetic macular edema”, “diabetes”, and “macular edema.” We then extracted the papers on the trials from the PubMed and Cochrane Review Database. We identified treatment protocols, DME and VA inclusion criteria, patient characteristics, and main study outcomes. Early Treatment Diabetic Retinopathy Study (ETDRS) letters were converted to Snellen lines using a conversion chart (Figure).
We found five phase III RCTs: VIVID/VISTA, RIDE/RISE, Macugen DME study, DRCR.net Protocol I, and RESTORE (Table). They compared the efficacy of ranibizumab (IVR) with or without laser, pegaptanib (IVP), and aflibercept (IAI) to controls (sham injections, laser, or triamcinolone and laser). Protocols and baseline OCT and VA criteria varied significantly. Patients had type I or II diabetes and a mean age of 62-64. Baseline mean central retinal thickness (CRT) and VA ranged from 405-520 μm and 20/50-20/80, respectively. Anti-VEGF led to significantly better VA than controls even when adjusting for age, gender, focal versus diffuse DME, ischemia, retinopathy severity, and baseline CRT. A lower baseline VA was associated with greater VA improvement.
By matching OCT and VA criteria with specific patient characteristics, treatment protocols and outcomes, clinicians and their patients can make evidence-based decisions about how to initiate anti-VEGF therapy for DME. Standardizing future DME studies would significantly aid clinicians in implementing evidence-based therapy.
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