September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Progression of Diabetic Retinopathy in the Bevordex study: a randomized clinical trial of intravitreal bevacizumab versus intravitreal dexamethasone for diabetic macular edema
Author Affiliations & Notes
  • Lyndell L Lim
    Centre for Eye Research Australia, University of Melbourne, East Melbourne, Victoria, Australia
    Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia
  • Dania Qatarneh
    Centre for Eye Research Australia, University of Melbourne, East Melbourne, Victoria, Australia
  • Lauren Hodgson
    Centre for Eye Research Australia, University of Melbourne, East Melbourne, Victoria, Australia
  • Hemal Mehta
    Save Sight Institute, The University of Sydney, Sydney, New South Wales, Australia
  • Sanjeewa Wickremasinghe
    Centre for Eye Research Australia, University of Melbourne, East Melbourne, Victoria, Australia
    Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia
  • Anna Campain
    Save Sight Institute, The University of Sydney, Sydney, New South Wales, Australia
  • Mark C Gillies
    Save Sight Institute, The University of Sydney, Sydney, New South Wales, Australia
  • Samantha Fraser-Bell
    Save Sight Institute, The University of Sydney, Sydney, New South Wales, Australia
  • Footnotes
    Commercial Relationships   Lyndell Lim, Abbvie (R), Allergan (R), Bayer (F), Bayer (R), Novartis (F); Dania Qatarneh, Bayer (F); Lauren Hodgson, None; Hemal Mehta, None; Sanjeewa Wickremasinghe, Bayer (R), Bayer (S), Novartis (R), Novartis (S); Anna Campain, None; Mark Gillies, Allergan (F), Allergan (R); Samantha Fraser-Bell, Allergan (F), Allergan (R), Bayer (F)
  • Footnotes
    Support  NHMRC Project Grant 2010; Allergan Unrestricted Educational Grant
Investigative Ophthalmology & Visual Science September 2016, Vol.57, 2106. doi:
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      Lyndell L Lim, Dania Qatarneh, Lauren Hodgson, Hemal Mehta, Sanjeewa Wickremasinghe, Anna Campain, Mark C Gillies, Samantha Fraser-Bell; Progression of Diabetic Retinopathy in the Bevordex study: a randomized clinical trial of intravitreal bevacizumab versus intravitreal dexamethasone for diabetic macular edema. Invest. Ophthalmol. Vis. Sci. 2016;57(12):2106.

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

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Abstract

Purpose : To compare the effect of bevacizumab (Avastin; Genentech, South Francisco, CA) with dexamethasone implants (Ozurdex; Allergan, Inc., Irvine, CA) on the progression of diabetic retinopathy (DR).

Methods : Post-hoc analysis of 24 month data from a phase 2, prospective, multicenter, randomized, single-masked clinical trial (clinicaltrials.gov identifier NCT01298076). Eightly-eight eyes of 61 patients with center-involving diabetic macular edema (DME) were recruited: 42 eyes were randomized to receive bevacizumab every 4 weeks and 46 eyes were randomized to receive a dexamethasone implant every 16 weeks, both pro re nata. Main outcome measures included change in DR severity based on reading center assessment of color fundus photographs using the modified Airlie House scale, and development of clinically important events defining high-risk proliferative diabetic retinopathy (PDR).

Results : Neither treatment showed a statistically significant propensity toward increasing or decreasing the DR grade at 1 and 2 years, with no significant difference between the two groups (p=0.71). Despite ongoing treatment, a small number of eyes developed PDR at 2 years; 1 eye (3%) receiving Bevacizumab and 7 eyes (18.9%) receiving Dexamethasone (p=0.05 Fisher’s exact test). There was no association between HbA1C, systemic blood pressure (BP) and progression of DR.

Conclusions : Both bevacizumab and dexamethasone implants have a similar effect on the progression of DR severity when administered for DME, with the majority of patients retaining the same grade on ETDRS photographic assessment after 1 and 2 years of follow up. Importantly, the development of PDR still occurred in some eyes undergoing either treatment, reinforcing the need to monitor all aspects of DR when actively managing DME with either of these treatments.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.

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