Elisa E Cornish1,2, Kelvin YC Teo2,3, Mark C Gillies1,2, Lyndell L Lim4, Ian L McAllister5, Sutha Sanmugasundram4, Goff J Quin6, Vuong Nguyen1, Sanjeewa S Wickremasinghe4, Hemal Mehta7, Samantha Fraser-Bell2,1
Purpose: BEVORDEX was a 2 year, multicenter, randomized clinical trial comparing dexamethasone (DEX-) implant q16weekly to bevacizumab q4weekly, both PRN, for diabetic macular oedema (DMO). There was no signiﬁcant difference in pri- mary endpoint of proportion of eyes gaining ≥10 let- ters in visual acuity (VA) between the 2-groups. Here, we report 5 year outcomes.
Methods: After completing the BEVORDEX study, treatment of DMO reverted to standard of care. A chart review was performed to obtain VA and cen- tral subﬁeld thickness (CST) measurements up to 5 years from enrolment.
Results: Of the 88 ex-BEVORDEX eyes, data were available on 72, 63 and 52 eyes for 3, 4 and 5 years respectively.
Proportion of patients with ≥10 letter gain (14/46 (31%) & 14/42 (33%)), change in VA (+1 & +5 let- ters) and change in CST (-150 &-192μm) was not signiﬁcantly different between the DEX-implant and bevacizumab groups at 5 years. DEX-implant treated eyes received fewer treatments over 5 years (9 vs 19, P < 0.05). Cataract surgery rates were similar over 5 years ((26/31 (84%) Dex-implant & 23/34 (68%) bevacizumab). More eyes in the DEX-implant group developed proliferative diabetic retinopathy (PDR) (6/31 vs 1/32, P < 0.05). All these eyes had severe non-PDR at enrolment into BEVORDEX. Conclusion: At 5 years, VA and CST were similar for eyes initially randomized to DEX-implant and bevacizumab during BEVORDEX. Treatment bur- den for patients in the DEX-implant group remained lower at 5 years. More eyes in the DEX-implant group developed PDR. Over 5 years, prevalence of cataract surgery was similar between the 2 groups.
COMPARISON OF RANIBIZUMAB AND AFLIBERCEPT IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION TREATED FOLLOWING A ?TREAT AND EXTEND? PROTOCOL: EFFICACY VARIABLES FROM THE PRE-SPECIFIED 12- MONTH INTERIM ANALYSIS OF THE RIVAL STUDY