April 2014
Volume 55, Issue 13
Free
ARVO Annual Meeting Abstract  |   April 2014
Evaluation of Intravitreal Aflibercept for Treatment of Diabetic Macular Edema: Visual Acuity Subgroups in VIVID-DME and VISTA-DME
Author Affiliations & Notes
  • Katrin Lorenz
    Department of Ophthalmology, University Medical Center Mainz, Mainz, Germany
  • Footnotes
    Commercial Relationships Katrin Lorenz, Bayer (R), Ivantis (F), Ivantis (R), MSD (R), Sensimed AG (F), Sensimed AG (R)
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science April 2014, Vol.55, 5054. doi:
  • Views
  • Share
  • Tools
    • Alerts
      ×
      This feature is available to authenticated users only.
      Sign In or Create an Account ×
    • Get Citation

      Katrin Lorenz, ; Evaluation of Intravitreal Aflibercept for Treatment of Diabetic Macular Edema: Visual Acuity Subgroups in VIVID-DME and VISTA-DME. Invest. Ophthalmol. Vis. Sci. 2014;55(13):5054.

      Download citation file:


      © ARVO (1962-2015); The Authors (2016-present)

      ×
  • Supplements
Abstract
 
Purpose
 

The Phase 3 trials VIVID-DME and VISTA-DME evaluated the efficacy and safety of 2 mg intravitreal aflibercept injection (IAI or IVT-AFL) for the treatment of diabetic macular edema (DME). Post-hoc subanalyses were conducted using data from patients within these trials who had baseline best-corrected visual acuity (BCVA) of ≥39 to ≤60 or ≥61 to ≤73 letters.

 
Methods
 

In VIVID-DME (N=406) and VISTA-DME (N=466), patients received laser photocoagulation + sham injection or 5 monthly doses of IAI followed by dosing every 4 weeks + sham laser (2q4) or every 8 weeks + sham laser (2q8). Here we present post-hoc subanalyses of 52-week data from the studies.

 
Results
 

Mean baseline demographics and disease characteristics were balanced within studies. The mean increase in BCVA from baseline was significantly greater in the 2q4 and 2q8 arms vs laser in VIVID-DME (10.5, 10.7, and 1.2, respectively, P<0.0001) and in VISTA-DME (12.5, 10.7, and 0.2 letters, respectively, P<0.0001). In patients with a baseline BCVA of ≥39 to ≤60 letters (~37% in both studies), the mean increase in BCVA from baseline was greater in the IAI 2q4 and 2q8 arms vs laser in VIVID-DME (11.9, 11.3, and 2.5 letters, respectively) and VISTA-DME (13.7, 11.4, and 2.6 letters, respectively). In patients with baseline BCVA ≥61 to ≤73 letters (~55% in both trials), the mean increase in BCVA from baseline was greater in the IAI 2q4 and 2q8 arms vs laser in VIVID-DME (9.1, 8.6, and 0.7 letters, respectively) and VISTA-DME (10.5, 9.9, and -0.4 letters, respectively). In the overall population of these studies, the percentage of patients with ≥1 ocular serious adverse events in VIVID-DME was 4.5% in the laser arm and 1.8% in the combined IAI arms and in VISTA-DME was 3.9% in the laser arm and 1.6% in the combined IAI arms.

 
Conclusions
 

Subgroup analysis by baseline BCVA in the VIVID-DME and VISTA-DME showed BCVA changes that were consistent with the overall population. Both laser and IAI treatment resulted in slightly better visual outcomes in patients with a baseline BCVA of ≥39 to ≤60 letters in comparison with those with a baseline BCVA of ≥61 to ≤73 letters. These results demonstrate the efficacy of IAI for the treatment of DME and compare favorably with results of similar subgroup analyses in studies of other anti-VEGF compounds.

 
Keywords: 498 diabetes • 688 retina • 748 vascular endothelial growth factor  
×
×

This PDF is available to Subscribers Only

Sign in or purchase a subscription to access this content. ×

You must be signed into an individual account to use this feature.

×