Aim To report the 6-month results of a clinical trial that compared intravitreous bevacizumab (BVB) 1.25 mg versus triamcinolone acetonide (TA) 4 mg when administered as an adjunct during cataract surgery to patients with diabetic macular oedema (DMO).
Methods Prospective, double-masked, single-centre (Royal Victorian Eye and Ear Hospital, Melbourne) clinical trial. Patients with visually significant cataract and centre-involving DMO (either current or prior) were randomised (1: 1) to receive either intravitreous BVB 1.25 mg or TA 4 mg at the time of cataract surgery and if required at review. Main outcome measures were changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT) from baseline to the 6-month time point of this 12-month study.
Results 61 eyes of 58 patients were enrolled. At baseline, both groups were similar in terms of BCVA and CMT (p>0.2). At 6 months, there was no significant difference in vision between the groups, with mean letter gain of +21.4 (95% CI +14.5 to +28.4) in the TA group and +17.3 (95% CI +12.1 to +22.6) in the BVB group (p=0.35). The TA group had a significant sustained anatomical improvement at 6 months, with a reduction in CMT (−51.4 µm; 95% CI −98.2 to -4.7) compared with thickening in the BVB group (+15.6 µm; 95% CI −26.4 to +57.7, p=0.04).
Conclusions When given as an adjunct to cataract surgery, both TA and BVB improved visual outcomes at 6 months postoperatively. However, only TA resulted in sustained improvement in CMT, with the majority not requiring any further treatment postoperatively.
- diabetic macular oedema
- cataract surgery
- randomised clinical trial
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Contributors SLR, SAQ and LLL contributed to the conception or design of work. MC, SSS, SW, SAQ and LLL contributed to the data collection. SLR, RK and LLL contributed to the data analysis and/or interpretation. All authors contributed to the drafting of the article and critical review of the article.
Funding This study has received funding from the Royal Victorian Eye and Ear Hospital Grants Program 2013–2014 (Melbourne), Diabetes Australia Research Program Grant 2015 (Canberra), Ramaciotti Health Investment Grant 2016 (Sydney) and the Hazel Jean Eastham Bequest (Melbourne). Centre for Eye Research Australia receives operational infrastructure support from the Victorian government. Associate Professor Lim (GNT 1109330) and Dr Wickremasinghe (GNT 1128343) are supported by National Health and Medical Research Council (NHMRC) Early Career Fellowships. The sponsor or funding organisations had no role in the design or conduct of the study; collection, management, analysis and interpretation of the data; preparation, review or approval of the manuscript or decision to submit the manuscript for publication. Dr Kandasamy and Associate Professor Lim had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Competing interests A/Prof Lim has received consultancy fees from Abbvie, Allergan and Bayer, and her institution has received research funding from Bayer that does not pertain to this study.
Patient consent for publication Obtained.
Ethics approval The trial received approval from the Human Research Ethics Committee of the RVEEH.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement The trial data includes confidential patient medical information and patient informed consent was not obtained for the purpose of storing such data onto an online repository for public access.
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