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. 2023 Jan;107(1):79-83.
doi: 10.1136/bjophthalmol-2021-319839. Epub 2021 Aug 2.

Five-year outcomes of eyes initially enrolled in the 2-year BEVORDEX trial of bevacizumab or dexamethasone implants for diabetic macular oedema

Elisa E Cornish  1   2 , Kelvin Yc Teo  3   4 , Mark C Gillies  3   2 , Lyndell L Lim  5 , Vuong Nguyen  3 , Sanjeewa Wickremasinghe  5 , Hemal Mehta  3   6 , Ian L McAllister  7 , Samantha Fraser-Bell  3   2
Affiliations

Five-year outcomes of eyes initially enrolled in the 2-year BEVORDEX trial of bevacizumab or dexamethasone implants for diabetic macular oedema

Elisa E Cornish et al. Br J Ophthalmol. 2023 Jan.

Abstract

Background: The BEVORDEX trial compared outcomes of eyes with diabetic macular oedema (DMO) randomised to receive either intravitreal dexamethasone (DEX-) implant or bevacizumab over 2 years. We assessed long-term efficacy and safety outcomes 5 years from enrolment.

Methods: Patients received standard clinical care after they finished the study. Their files were reviewed for visual and anatomical outcomes, post-trial treatments and complications.

Results: Three-year and five-year data were available for 82% and 59% of eyes enrolled in the BEVORDEX study, respectively. Visual acuity gains at end of trial were generally lost by both treatment groups at 5 years but the macular thickness did not change from end of trial to 5 years. A similar proportion of eyes from each treatment group gained ≥10 letters at 5 years from enrolment in the BEVORDEX trial.Eyes that were initially randomised to the DEX-implant group had significantly fewer treatments but were more likely to develop proliferative diabetic retinopathy (PDR) over the 5-year period compared with eyes initially randomised to bevacizumab. The proportion of eyes that had cataract surgery by 5 years was similar between initial treatment groups.

Conclusions: Eyes in the BEVORDEX trial had similar 5-year rates of cataract surgery, however, more eyes converted to PDR in the group initially treated with DEX-implant. Eyes that were initially treated for 2 years with either intravitreal DEX-implant of bevacizumab followed by standard of care had similar visual and anatomical outcomes at 5 years.

Keywords: macula; treatment medical.

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Conflict of interest statement

Competing interests: MCG: grant—Allergan; personal fees—Bayer; consultant—Allergan, Novartis, Bayer; expert testimony—Bayer. SF-B: consultant—Allergan, Bayer, Novartis, LLL: consultant—Bayer, Norvartis, Abbvie, Allergan; speaker fees—Bayer, Abbvie. HM: consultant—Allergan, Bayer, Novartis, Roche. KYCT: no financial disclosures. EEC: no financial disclosures. VN: no financial disclosures. ILM: Ad Board—Novartis, Bayer and Allergan. SW: Ad Board—Allergan; speaker fees—Bayer, Allergan.

Figures

Figure 1
Figure 1
Visual acuity (VA) and central macular thickness (CMT) of each treatment group of the BEVORDEX trial followed to 5 years from enrolment. (A) Mean VA logMAR letters; (B) mean CMT μm. Error bars denote CI. DEX-implant, dexamethasone implant.
See this image and copyright information in PMC

References

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