July 2018
Volume 59, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2018
Five year outcomes of the Bevordex Study (a multicenter randomized clinical trial of intravitreal bevacizumab versus intravitreal dexamethasone).
Author Affiliations & Notes
  • Elisa Eleanor Cornish
    Ophthalmology, Sydney Eye Hospital, Sydney, New South Wales, Australia
    Save Sight and Eye Health Institute, Sydney Medical School, Sydney University, Sydney, New South Wales, Australia
  • Kelvin Yi Chong Teo
    Ophthalmology, Sydney Eye Hospital, Sydney, New South Wales, Australia
    Singapore National Eye Centre, Singapore, Singapore
  • Mark C Gillies
    Ophthalmology, Sydney Eye Hospital, Sydney, New South Wales, Australia
    Save Sight and Eye Health Institute, Sydney Medical School, Sydney University, Sydney, New South Wales, Australia
  • Lyndell L Lim
    Centre for Eye Research Australia, University of Melbourne, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia
  • Ian McAllister
    Lions Eye Institute, Centre for Ophthalmology and Visual Sciences, University of Western Australia, Perth, Western Australia, Australia
  • Sutha Sanmugasundram
    Centre for Eye Research Australia, University of Melbourne, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia
  • Vuong Nguyen
    Save Sight and Eye Health Institute, Sydney Medical School, Sydney University, Sydney, New South Wales, Australia
  • Sanjeewa Wickremasinghe
    Centre for Eye Research Australia, University of Melbourne, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia
  • Hemal Mehta
    Ophthalmology, Royal Free London NHS Foundation Trust, London, United Kingdom
  • Samantha Fraser-Bell
    Ophthalmology, Sydney Eye Hospital, Sydney, New South Wales, Australia
    Save Sight and Eye Health Institute, Sydney Medical School, Sydney University, Sydney, New South Wales, Australia
  • Footnotes
    Commercial Relationships   Elisa Cornish, None; Kelvin Yi Chong Teo, None; Mark Gillies, Allergan (F), Allergan (R), Bayer (F), Bayer (R), Novartis (F); Lyndell Lim, Abbvie (F), Allergan (F), Allergan (C), Bayer (F); Ian McAllister, Allergan (C), Bayer (C), Novartis (C); Sutha Sanmugasundram, None; Vuong Nguyen, None; Sanjeewa Wickremasinghe, Allergan (R), Bayer (R), Novartis (R); Hemal Mehta, Allergan (C); Samantha Fraser-Bell, Allergan (F), Allergan (R), Bayer (F), Bayer (R)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science July 2018, Vol.59, 4847. doi:
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      Elisa Eleanor Cornish, Kelvin Yi Chong Teo, Mark C Gillies, Lyndell L Lim, Ian McAllister, Sutha Sanmugasundram, Vuong Nguyen, Sanjeewa Wickremasinghe, Hemal Mehta, Samantha Fraser-Bell; Five year outcomes of the Bevordex Study (a multicenter randomized clinical trial of intravitreal bevacizumab versus intravitreal dexamethasone).. Invest. Ophthalmol. Vis. Sci. 2018;59(9):4847.

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

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Abstract

Purpose : There is a paucity of long term data in the treatment of centre-involving diabetic macular edema (DME). Diabetic retinopathy (DR) is a leading cause of acquired blindness among young adults in developed countries. Although severe vision loss may occur due to proliferative DR, the most common cause of visual loss in these patients is DME. This study aims describe the 5 year outcomes from the BEVORDEX study, a randomized controlled trial study comparing treatment of DME with dexamethasone implant (dex-implant) with bevacizumab.

Methods : In the BEVORDEX study, patients were initially assigned randomly to dex-implant or bevacizumab. After 2 years, patients were released from the clinical trial protocol and treated as per their treating physician. Data to 5 years from entry into the BEVORDEX study were collected including visual acuity (VA), central macular thickness (CMT), diabetic retinopathy status and treatments. An intension-to-treat analysis was conducted.

Results : From the 68 eyes that completed the 2 year Bevordex study, 5 year outcomes from 49 eyes (72%) (27 bevacizumab and 22 dex-implant) were available. The overall mean number of visits was 14.7 (CI= 11.2–16.2) with no significant difference between the 2 groups, 15 visits (CI= 11.3–18.6) for bevacizumab versus 12 visits (CI= 8.5–15.9) for the dex-implant treatment group.
The mean VA at 5 years was 59 letters [CI= 53–64] which was not significantly different from mean VA at end of trial of 65 letters [CI= 60–69] (p=0.09).The proportion of eyes that achieved 20/40 or better vision was not significantly different from the end of trial (40%) to at 5 years (37.5%) (p= 0.7).
The CMT at 5 years was 331.4 μm [CI= 294–368] which was not significantly different from end of trial CMT of 334.0 μm [295 - 372] (p= 0.9).
The overall mean number of treatments was 3.4 (CI= 2.4–4.5) with no significant difference between the orginal BEVORDEX treatment groups; bevacizumab 4 [CI= 2.2–5.8] and dex-implant 3 [CI= 1.8–4.1] (p= 0.3).

Conclusions : Mean vision, the proportion of eyes that achieved 20/40 or better vision and macula thickness at the exit of the trial was maintained at 5 years. The overall treatment burden was also found to remained low at 5 years.

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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