Abstract
Purpose :
This study aims to examine the real world visual and anatomic outcomes, outside the trial setting, using a retrospective electronic case note review.
Methods :
A consecutive series of patients attending a UK Macular Clinic in a predefined time-period were selected who had at least three injections of aflibercept for DMO. Best corrected visual acuity (BCVA), optical coherence tomographic (OCT) parameters of central retinal thickness (CRT) and macular volume (MV) on Spectralis OCT maps (Heidelberg) was recorded.
Results :
26 eyes of 18 patients (14 males, all type II DM) had no prior intravitreal injections. Mean age was 63.8 years (sd 8.1). Mean number of injections received per eye was 5.9 (sd 2.1, range 3-10, with 12/26 having had 3-5 injections only), over a mean time of 37.3 weeks (sd 9.3, range 10-56). With aflibercept, 18/26 eyes (69.2%) had improved BCVA, 1/26 (3.9%) had no change and 7/26 (26.9%) had worsening (mean BCVA change +6 letters, sd 14.6, range -37 to +39). Reduction of CRT and MV occurred in 24/26 eyes (92.3%) (mean CRT change -112.4 μm, sd 93.7, range -389 to +89; mean MV change -0.9 mm3, sd 0.9, range -3.3 to +0.6). 36 eyes of 21 patients (13 males, 13 with type II DM) switched from ranibizumab to aflibercept. Mean age was 61.8 years (sd 15.7) and mean duration since DM diagnosis of 18.9 years (sd 12.2). A mean of 11.9 (sd 5.0, range 1-20) injections were given prior to commencing aflibercept. Reasons for switching were poor response to ranibizumab (n=17), recurrence of macular oedema within 4 weeks (n=3) and an inflammatory reaction to ranibizumab (n=1). Mean number of aflibercept injections received was 5.8 (sd 2.0, range 3-9, with 17/36 eyes having 3-5 injections only) over a mean of 41.1 weeks (sd 9.9, range 20-54). After switching, improvement in BCVA occurred in 24/36 (66.7%), 5/36 (13.9%) had no change and worsening in 7/36 of eyes (19.4%), (mean improvement 3.1 letters, sd 7.3, range -14 to +35). CRT and MV each reduced in 24/36 eyes (66.7%) (mean CRT reduction -46.5μm, sd 127.8, range -435 to 368; mean MV reduction -0.6, sd +1.0, range -3.6 to +0.9)
Conclusions :
These results are encouraging given variation in the sample in injection number, mean injection frequency of 6-7 weekly and the nature of the real world in which ocular co-morbidities are seen, precluding entry into trials. Further work is needed with bigger samples, and to explore what factors are associated with lack of success.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.