July 2018
Volume 59, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2018
Treat and Extend Versus Bi-monthly dosing with Aflibercept for the Treatment of Diabetic Macular Edema, One Year Outcomes (EVADE Study)
Author Affiliations & Notes
  • Jack M Giust
    Research Department, California Retina Consultants, Santa Barbara, California, United States
  • Alessandro Castellarin
    Research Department, California Retina Consultants, Santa Barbara, California, United States
  • Nathan Steinle
    Research Department, California Retina Consultants, Santa Barbara, California, United States
  • Dante Joseph Pieramici
    Research Department, California Retina Consultants, Santa Barbara, California, United States
  • Robert F. See
    Research Department, California Retina Consultants, Santa Barbara, California, United States
  • Robert L Avery
    Research Department, California Retina Consultants, Santa Barbara, California, United States
  • Gabriel M Gordon
    Research Department, California Retina Consultants, Santa Barbara, California, United States
  • Dilsher Dhoot
    Research Department, California Retina Consultants, Santa Barbara, California, United States
  • Footnotes
    Commercial Relationships   Jack Giust, None; Alessandro Castellarin, None; Nathan Steinle, None; Dante Pieramici, None; Robert See, None; Robert Avery, None; Gabriel Gordon, None; Dilsher Dhoot, None
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science July 2018, Vol.59, 1957. doi:
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    • Get Citation

      Jack M Giust, Alessandro Castellarin, Nathan Steinle, Dante Joseph Pieramici, Robert F. See, Robert L Avery, Gabriel M Gordon, Dilsher Dhoot; Treat and Extend Versus Bi-monthly dosing with Aflibercept for the Treatment of Diabetic Macular Edema, One Year Outcomes (EVADE Study). Invest. Ophthalmol. Vis. Sci. 2018;59(9):1957.

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

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Abstract

Purpose : To determine the benefits of a treat and extend (TE) regimen versus a fixed interval (FI) dosing regimen in subjects with diabetic macular edema (DME) receiving intravitreal aflibercept injections (IAIs).

Methods : Prospective trial of 50 eyes with DME randomized on a 1:1 ratio into a FI arm (N=25) or a TE arm (N=25). Eyes in the FI arm received 5 consecutive monthly injections of IAI followed by IAI every 8 weeks thereafter. Eyes in the TE arm received IAI as frequently as every 4 weeks and could be extended to a maximum of 16 weeks in the first year based on pre-determined visual acuity and OCT parameters. Main outcome measures included change in best-corrected visual acuity (BCVA), mean central retinal thickness (CRT), percentage of eyes gaining/losing 3 lines of vision, and the mean number of injections received.

Results : Baseline demographics were balanced between both treatment groups and 86% of patients completed the 1- year follow-up visit. At 1 year, the mean BCVA improved from 57 to 64 (7±9) and 61 to 74 (13±7) letters in the FI and TE groups, respectively (P=0.002, p<0.001); the BCVA in the TE arm was significantly more improved when compared to the FI arm (p=0.007). The percentage of patients gaining 3 lines of vision was 21.7% and 31.6% in the FI and TE groups, respectively (P=0.47). Mean CRT improved from 484 to 315 mm (169±147 mm) in the FI arm and from 516 to 302 mm (214±81 mm) in the TE arm (both p<0.001). The TE arm showed significantly more visits (10.1 vs 8.8, p=0.02) and injections (9.9 vs 8.8, p=0.03) than the FI arm. In the TE arm, 5 subjects (28%) were reduced to 4 week intervals, 2 (11%) were reduced to 6 weeks, 3 (17%) remained at 8 weeks, 6 (33%) were increased to 10-weeks, none (0%) were increased to 12-weeks, 1 subject (6%) was increased to 14 weeks, and 1 subject (6%) was increased to 16-weeks. The incidence of APTC events was 2% and there were no cases of endophthalmitis

Conclusions : At the end of 1 year, visual acuity gains significantly favored the TE arm which also had increased number of injections and visits. Although both the FI and TE arms had similar anatomic outcomes at one year, the increased frequency of treatment when fluid recurred in the TE arm was associated with better visual outcomes than in the fixed q 8 week arm of this small study. Treat and extend is a viable treatment option in some patients.

This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.

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