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Aim: To determine whether early vision gains predict long-term visual outcomes in the BEVORDEX randomised clinical trial of bevacizumab or dexamethasone implants for diabetic macular oedema., Methods: Post hoc analysis of 68 study eyes (77%) that completed 2 years follow-up of the BEVORDEX multicentre randomised clinical trial set in Australia (ClinicalTrials.gov identifier: NCT01298076). Study eyes from both groups were combined and stratified by visual acuity (VA) change in the first 12 weeks in to three groups: (a) suboptimal gain: <5 letters gain (includes VA loss), (b) moderate gain: 5-9 letters gain, (c) pronounced gain: ≥10 letters gain. This was correlated with VA outcome at 104 weeks taking into account treatment allocation and baseline lens status., Results: The change in VA in the first 12 weeks was significantly correlated with VA change at 104 weeks (p<0.001). This was independent of treatment allocation (p=0.353) and lens status at baseline (p=0.593). The change in central macular thickness at 12 weeks did not correlate with VA gain at 104 weeks (p=0.847)., Conclusion: Short-term visual gain at 12 weeks was strongly correlated with long-term vision improvement independent of treatment allocation or baseline lens status. Early improvement in central macular thickness was not predictive of long-term visual outcomes., Trial Registration Number: NCT01298076, Post-results., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Purpose: To report increasing retreatment interval of intravitreal bevacizumab and dexamethasone implants for diabetic macular edema (DME) in the BEVORDEX trial., Design: Multicenter randomized clinical trial., Participants: Sixty-eight eyes from 47 patients who completed 2 years of follow-up., Methods: The BEVORDEX study (www.clinicaltrials.gov identifier, NCT01298076), set in Australia, was the first head-to-head trial of bevacizumab (Avastin; Genentech, South San Francisco, CA), with retreatment considered after 4 weeks, versus a slow-release dexamethasone implant (Ozurdex; Allergan Inc., Irvine, CA), with retreatment possible after 16 weeks, for center-involving DME. Study eyes were assessed every 4 weeks for retreatment according to prespecified visual acuity and central macular thickness criteria. In this post hoc analysis, changes in treatment interval over time were examined using mixed-effects regression models. We assessed whether the mean treatment interval changed over time and if this depended on baseline characteristics or the treatment received., Results: Of the 68 eyes from 47 patients, 67 study eyes received at least 1 retreatment (1 eye in the dexamethasone implant group did not require retreatment over 24 months). Thirty-two eyes received bevacizumab and 35 eyes received dexamethasone implants. Study eyes received a mean of 14.6 injections (standard deviation [SD], 7.8 injections) and 5.6 injections (SD, 1.4 injections) in the bevacizumab and dexamethasone groups, respectively, over 2 years. The mean retreatment interval over the 2-year follow-up period was 70.8 days (SD, 43.8 days) for the bevacizumab group and 145 days (SD, 45.4 days) for the dexamethasone implant group. The mean treatment interval increased over time for both drugs (P = 0.016), independent of which treatment was received (P = 0.808). Longer treatment interval over time was associated with younger age (P = 0.037) and better baseline visual acuity (P = 0.026), but not with gender (P = 0.907) or baseline central macular thickness (P = 0.900)., Conclusions: The increase in treatment interval for both intravitreal bevacizumab and dexamethasone implants over time has implications when informing patients about potential treatment burden for DME, planning intravitreal injections services, and designing future clinical trials. For drugs with a disease-modifying effect, fixed-interval dosing may not be required beyond an initial loading phase., (Copyright © 2017 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)

Purpose: To compare changes in retinal vascular calibre after 2 years of treatment with intravitreal bevacizumab (BVZ) or dexamethasone implant (DEX) in patients with centre-involving diabetic macular oedema (DMO)., Methods: At baseline, 88 eyes of 61 patients with DMO were recruited in a prospective, multicentre, randomised, single-masked clinical trial. Of these subjects, 22 BVZ-treated (52%) and 22 DEX-treated (48%) eyes of 34 patients (56%) had gradable retinal photographs at both the baseline and 24-month visits. Retinal vascular calibre was measured from digital fundus photographs and summarised as central retinal artery (CRAE) and vein (CRVE) equivalents in all gradable eyes at baseline and 24 months., Results: At 24 months, 40.9% of BVZ and 45.5% of DEX eyes gained 10 or more letters (p=0.77). There was concurrent reduction in mean central macular thickness, -157.7 μm in BVZ and -192.5 μm in DEX-treated eyes (p=0.40). DEX-treated eyes showed a statistically significant reduction in CRVE compared with BVZ-treated eyes, with a mean change from baseline of -31.78 to +4.34 µm, respectively (p<0.001). CRAE showed a non-statistically significant trend towards reduction over time in DEX-treated eyes compared with BVZ-treated eyes, with a mean change from baseline of -6.09 and +1.66, respectively (p=0.077)., Conclusions: DEX had a significant narrowing effect on venular diameter in eyes with DMO not seen with BVZ. The changes in retinal vascular calibre suggest that these agents have a differing actions effects retinal vasculature and thereby suggest a potentially different mechanism of action on reducing DMO., Trial Registration Number: NCT01298076., Competing Interests: Competing interests: None declared., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)

Purpose: To determine the patient-centered effectiveness of treatment with the slow-release dexamethasone intravitreal implant (DEX implant) and intravitreal bevacizumab using the Impact of Vision Impairment Questionnaire (IVI), a vision-related quality of life (VRQoL) measure, in patients with visual impairment secondary to center-involving diabetic macular edema (DME)., Methods: Patients with DME were enrolled in a phase 2, prospective, multicenter, randomized, single-masked clinical trial and received either DEX implant 4 monthly or bevacizumab monthly, both pro re nata. Vision-related quality of life was measured at baseline and 24 months, using the IVI's three component scales, namely reading, mobility, and emotional well-being. Rasch analysis was used to generate interval-level estimates of VRQoL, which were then analyzed using t-tests to assess changes over time., Results: Forty-eight patients completed the main study; 43 (90%) answered the IVI at the baseline and 24-month (final efficacy) visits. Vision-related quality of life improved significantly, with average increases of 1.44, 0.99, and 1.49 logits, for the reading, mobility, and emotional well-being scales respectively, from baseline to 24 months, (P < 0.001). There was no significant between-group difference in improvement in VRQoL in the DEX implant only compared with the bevacizumab-only group, in any of the three scales listed above (with 1.41, 1.08, and 2.11 logits improvement, in reading, mobility, and emotional well-being, respectively, for DEX implant group, compared with 1.48, 1.06, and 2.11 for bevacizumab; P values > 0.1.)., Conclusions: We found that both DEX implant and bevacizumab treatment result in significant and similar improvements in VRQoL in patients with DME over a 24-month period. (Clinicaltrials.gov identifier NCT01298076).

Objective: To report the effect of bevacizumab versus dexamethasone on hard exudates (HEX) in diabetic macular oedema (DME)., Design: Post hoc analysis of 24-month data from the Randomised clinical trial of BEVacizumab OR DEXamethasone for diabetic macular oedema (BEVORDEX) phase 2 multicentre randomised clinical trial. Eyes with centre-involving DME resistant to or unlikely to benefit from macular laser therapy were included. Eyes were randomly assigned to bevacizumab every 4 weeks or Ozurdex dexamethasone implant (DEX) every 16 weeks, both as required. The 68 eyes from 48 patients that completed 24-month follow-up were analysed. Two masked graders assessed extent and location of HEX on baseline, 12-month and 24-month foveal-centred colour fundus photographs using validated grading software., Results: Macular HEX was present in 60% of study eyes. Of these, 21 eyes were treated with DEX and 20 eyes with bevacizumab. Both treatments led to reduction in area of macular HEX at 12 months and 24 months. There was greater regression of HEX from the foveal centre in DEX-treated eyes (median change +890 µm, IQR=1040 µm) than bevacizumab-treated eyes (median change +7.0 µm, IQR=590 µm) at 12 months (p=0.04) but the difference was no longer statistically significant (p=0.10) by 24 months (DEX +1400 µm, IQR=1590 µm; bevacizumab +20 µm, IQR=2680 µm). Reassuringly, no study eye developed HEX at the foveal centre, a visually devastating consequence of diabetic maculopathy., Conclusions: Bevacizumab and DEX were effective in reducing area of HEX in eyes with DME. DEX provided more rapid regression of HEX from the foveal centre although bevacizumab-treated eyes started to catch up by 24 months. Distance from the foveal centre as well as total area of macular HEX should be assessed when evaluating treatments for foveal-threatening HEX., Trial Registration Number: NCT01298076; Post-results., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)

Objective: To report the 12-month results of the first head-to-head comparison of a dexamethasone implant (Ozurdex; Allergan, Inc., Irvine, CA) versus bevacizumab (Avastin; Genentech, South San Francisco, CA) for center-involving diabetic macular edema (DME)., Design: Phase 2, prospective, multicenter, randomized, single-masked clinical trial (clinicaltrials.gov identifier NCT01298076)., Participants: We enrolled 88 eyes of 61 patients with center-involving DME., Methods: Forty-two 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. Results were analyzed using linear regression with generalized estimation equation methods to account for between-eye correlation., Main Outcome Measures: The primary outcome was the proportion of eyes that improved vision by 10 logarithm of minimum angle of resolution letters. Secondary outcomes included mean change in best-corrected visual acuity (BCVA), change in central macular thickness (CMT), injection frequency, and adverse events. Patient-reported outcomes were measured using the Impact of Vision Impairment (IVI) questionnaire., Results: Improvement in BCVA of 10 or more letters was found in 17 of 42 eyes (40%) treated with bevacizumab compared with 19 of 46 dexamethasone implant-treated eyes (41%; P = 0.83). None of the 42 bevacizumab eyes lost 10 letters or more, whereas 5 of 46 (11%) dexamethasone implant eyes did, mostly because of cataract. Mean CMT decreased by 122 μm for bevacizumab eyes and by 187 μm for dexamethasone implant eyes (P = 0.015). Bevacizumab-treated eyes received a mean of 8.6 injections compared with 2.7 injections for dexamethasone implant eyes. Significant improvement in IVI scores occurred for both treatment groups., Conclusions: Dexamethasone implant achieved similar rates of visual acuity improvement compared with bevacizumab for DME, with superior anatomic outcomes and fewer injections. Both treatments were associated with improvement in visual quality-of-life scores. However, more dexamethasone implant-treated eyes lost vision, mainly because of cataract., (Copyright © 2014 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)

Locally administered steroids have a long history in ophthalmology for the treatment of inflammatory conditions. Anterior segment conditions tend to be treated with topical steroids whilst posterior segment conditions generally require periocular, intravitreal or systemic administration for penetration. Over recent decades, the clinical applications of periocular steroid delivery have expanded to a wide range of conditions including macular oedema from retino‐vascular conditions. Formulations have been developed with the aim to provide practical, targeted, longer‐term and more efficacious therapy whilst minimizing side effects. Herein, we provide a comprehensive overview of the types of periocular steroid delivery, their clinical applications in ophthalmology and their side effects. [ABSTRACT FROM AUTHOR]

The efficacy of intravitreal dexamethasone implants for non-infectious posterior segment uveitis: Increasing the uveitis armamentarium Multicenter uveitis steroid treatment trial research G. Outcome of treatment of uveitic macular edema: the multicenter uveitis steroid treatment trial 2-year results. Multicenter uveitis steroid treatment trial research G. Periocular triamcinolone vs. intravitreal triamcinolone vs. intravitreal dexamethasone implant for the treatment of uveitic macular edema: the PeriOcular vs. [Extracted from the article]