Good real-world outcomes in DME patients with poor baseline visual acuity at 1 year: results from LUMINOUS^TM

Abstract

Purpose : Ranibizumab (RBZ) is approved for the treatment of visual impairment secondary to diabetic macular edema (DME). However, there are limited data on its use in DME patients in real-world settings. LUMINOUS^TM (NCT01318941) is an ongoing, 5-year, global, multicenter, observational, non-interventional, open-label study designed to evaluate the safety, efficacy, treatment patterns, and health-related quality of life outcomes associated with RBZ 0.5 mg treatment in clinical practice. Here we present baseline characteristics of 4427 DME patients enrolled before March 2015 and efficacy and safety results of 1828 DME patients enrolled before March 2014 who had the potential for 1-year follow-up, from the third interim analysis (IA) of LUMINOUS^TM.

Methods : Consenting adult (≥18 years) DME patients, who were treatment naïve (T1) or previously treated with RBZ (T2) /other ocular treatments (T3), were treated according to the local product label. Data were analyzed by prior treatment status of the primary treated eye.

Results : Baseline data are available from 4427 patients: mean age, 64.0 years; males, 57.2%; Caucasians, 73.9%; mean HbA_1c, 62.7 mmol/mol. T2 had higher baseline visual acuity (VA) (59.1 letters) and lower central retinal thickness (CRT) (370.4 μm) compared with other treatment groups (T1, VA: 53.9 letters, CRT: 414.8 μm; T3: VA: 55.6 letters, CRT: 430.1 μm). All three treatment groups showed improvement in VA and CRT at 1 year (Table). The VA improvements in T1 were similar to T3 at 1 year but with a lower mean number of injections and visits (Table). Treatment-naïve patients with relatively lower baseline VA (VA <23 letters and ≥23 to <39 letters) showed greater VA improvements than those with baseline VA ≥39 letters (Figure). The rate of ocular and non-ocular serious adverse events reported was 0.38% and 4.86%, respectively.

Conclusions : Prior RBZ-treated patients showed higher baseline VA and lower CRT versus treatment- naïve patients. One-year follow-up outcomes from LUMINOUS^TM showed VA improvement irrespective of previous treatment status. Greater VA improvements were observed in treatment naïve patients with a relatively low baseline VA (<39 letters). The results from this IA in LUMINOUS^TM support the well-established safety profile of RBZ.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.

 

Figure. VA outcomes stratified by baseline VA in treatment-naïve patients at 1-year

 

Table. Efficacy results at 1 year