Diabetic macular edema treated with ranibizumab in a large single center unselected population of 566 diabetic patients with a 2-4 year follow-up
Delila Hodzic-Hadzibegovic^1,2, Birgit Agnes Sander¹, Tine Juul Monberg¹, Michael Larsen^1,2, Henrik Lund-Andersen^1,2,3
1) Department of Ophthalmology, Rigshospitalet, Copenhagen, Denmark
2) Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
3) Steno Diabetes Center, Gentofte, Denmark

Abstract

Purpose : A retrospective, observational clinical study of functional and anatomical outcomes in patients treated with ranibizumab for diabetic macular edema (DME).

Methods : The study included 566 first-treated eyes in 566 patients with center-involving DME and best-corrected visual acuity (BCVA; Snellen) >0.05 and central subfield thickness (CST) ≥250 µm on spectral-domain optical coherence tomography who started treatment with ranibizumab from January 2011 to December 2013 at the Rigshospitalet. Clinical and demographic data were analyzed using a mixed model. Follow-up ranged from 2 to 4 years.

Results : Mean BCVA in approximate ETDRS letters and mean CST at baseline were 64.9 (SD 15.0) letters and 400.2 (SD 120.3) µm, respectively. Overall BCVA change from baseline was +4.0 (SD 12.7), +3.8 (SD 13.4), +2.8 (SD 12.1) and +5.7 (SD 11.6), respectively, after 1, 2, 3 and 4 years of follow-up. The corresponding CST change from baseline was -98.4(SD 115.0), -105.0 (SD 109.2),-103.8 (SD 93.6) and -131.1 (SD 132.6). In 14% of patients CST changed less than 10% within the first year. Larger BCVA treatment benefit at all time points was associated with lower baseline BCVA (P<0.0001), younger age (P<0.0001), higher baseline CRT (P=0.006), none previous pan retinal photocoagulation (P=0.004), none previous photocoagulation for DME (P=0.04) and higher HbA1c (P=0.008). The mean number of injections decreased from 5.5 the first year to 1.4 in the fourth year. At the conclusion of follow-up 23% remained in active ranibizumab treatment, 28% had changed to other intravitreal pharmacotherapy, 13% had been lost to follow-up, 3% had died, 30% had been discontinued because the condition had stabilized and 3% had been discontinued because further therapy was deemed futile. No endophthalmitis was registered.

Conclusions : In routine clinical practice, patients with DME experienced lower visual acuity gains and received fewer ranibizumab injections compared to major clinical trials. Priori photocoagulation was associated with a poorer visual outcome.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.