June 2015
Volume 56, Issue 7
Free
ARVO Annual Meeting Abstract  |   June 2015
Initiating Anti-VEGF Therapy for Diabetic Macular Edema: An Evidence-Based Guide
Author Affiliations & Notes
  • Rachel Vatsal Thakore
    Ophthalmology, Alpert Medical School, Providence, RI
    Ophthalmology, Providence VA Medical Center, Providence, RI
  • Paul B Greenberg
    Ophthalmology, Alpert Medical School, Providence, RI
    Ophthalmology, Providence VA Medical Center, Providence, RI
  • Footnotes
    Commercial Relationships Rachel Thakore, None; Paul Greenberg, None
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science June 2015, Vol.56, 1771. doi:
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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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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract
 
Purpose
 

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.

 
Methods
 

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).

 
Results
 

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.

 
Conclusions
 

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.  

 
ETDRS letters to Snellen lines conversion (+5 ETDRS letters for each line). Source: Beck et al. A Computerized Method of Visual Acuity Testing: Adaptation of the Early Treatment Diabetic Retinopathy Study Testing Protocol. Am J Ophthalmol. 2003;135:194-205.
 
ETDRS letters to Snellen lines conversion (+5 ETDRS letters for each line). Source: Beck et al. A Computerized Method of Visual Acuity Testing: Adaptation of the Early Treatment Diabetic Retinopathy Study Testing Protocol. Am J Ophthalmol. 2003;135:194-205.
 
 
Anti-VEGF treatment trials for diabetic macular edema
 
Anti-VEGF treatment trials for diabetic macular edema

 
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