Abstract
Purpose :
To compare visual and anatomical outcomes when either intravitreous bevacizumab (BVB, Avastin), or triamcinolone (TA, Triesence) is administered during cataract surgery in patients with Diabetic Macular Oedema (DME).
Methods :
This was a prospective, single-masked, randomised clinical trial conducted at The Royal Victorian Eye and Ear Hospital, Melbourne. Patients with clinically significant cataract and either centre-involving DME or DME that was treated in the previous 24 months were randomised 1:1 to receive intravitreal BVB 1.25mg or TA 4mg during cataract surgery, and at subsequent review if required over 12 months. Main outcome measures were change in central macular thickness (CMT) and best corrected visual acuity (VA) at 1, 3, 6 and 12 months post-surgery (as measured by masked observers).
Results :
Sixty-one eyes from 58 patients were initially recruited and treated, with 31 eyes continuing to 12months. At baseline, the BVB group (n, 28 eyes) was similar to the TA group (n, 33 eyes) in terms VA and central macular thickness (p>0.2) and this remained so with the 31 eyes (15 BVB, 16 TA) in the 12-month trial (p>0.1).
At 12 months, both groups gained VA from baseline (mean +18.5 letters [95CI +10.5 to +26.4] in the TA group and +15.7 [95CI +7.8 to +23.6] letters in BVB group), with no significant difference between the groups (mixed model p =0.209) . Although our 6-month data found that only TA was associated with a sustained reduction in CMT, at 12 months the difference was no longer statistically significant (median change in CMT -10 microns [IQR -35 to +10] for TA, -1.5 [IQR -26 to +13] for BVB, mixed model p = 0.099).
Additionally, during the first 6 months of the study, the majority (76%) of the TA group avoided the need for any further treatments compared to 43% in the BVB group (p=0.009), however by 12 months this had dropped to 62% in the TA group and 53% in the BVB group (p = 0.605).
Conclusions :
When administered at the time of cataract surgery in patients with DME, at 12 months both TA and BVB improve VA. Initial gains in CMT improvement and reduced need for any re-treatments in the TA group in the first 6 months was not maintained through to 12 months, however the overall treatment burden was still substantially lower in the TA group, whilst achieving the same visual gains.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.