Real-World Assessment of Dexamethasone Intravitreal Implant in Diabetic Macular Edema: Interim Analysis from the REINFORCE Study

Abstract

Purpose : Assessment of real-world efficacy and safety of 0.7 mg dexamethasone intravitreal implant (DEX; OZURDEX®; Allergan plc) as adjunctive or monotherapy in diabetic macular edema (DME) patients.

Methods : Ongoing, multicenter, prospective, observational registry study; data collected from patient’s 1st DEX injection; prior ocular history, treatment and outcomes at each subsequent visit up to 1 year. Interim analysis included all patients who completed at least 6 months of follow up.

Results : Ninety four patients (101 study eyes) were included; 88 patients (93.6%) were previously treated prior to 1st DEX injection. Duration of DME was ≥1 year in 73 (72.3%) eyes and ≥2 years in 51 (50.5%) eyes prior to study entry. DEX was administered as monotherapy in 63 (62.4%) eyes. Mean DEX injection frequency was 1.5 and mean reinjection interval in patients receiving multiple implants was 135.4 days (SD=42.48). Mean peak change in best corrected visual acuity (BCVA) from baseline after the 1st DEX implant was +8.2 letters* (p<0.0001) and mean peak BCVA change from baseline after the 2nd DEX implant was +8.7 letters* (p<0.01)(Figure 1). Mean peak BCVA change by month improved from 3 letters (SD=15.15) at Month 1 to 5.7 letters (SD=13.30) at Month 6. Percentage of study eyes with BCVA improvement of ≥15 letters from baseline during analysis period was 27.6%. Central retinal thickness (CRT) improved significantly from baseline at each month over the 1st 6 months following the 1st DEX injection with a mean peak change of -122.5 μm from baseline at Month 2 (p<0.0001) (Figure 2). Intraocular pressure increase (IOP; ≥10mmHg) occurred in 7.2% of eyes; 8.2% and 1% of eyes had an IOP of ≥25mmHg and ≥35mmHg respectively.

Conclusions : Patients with DME treated with DEX in real-world clinical practice, as either mono- or combination therapy, significantly improved both BCVA and CRT. There were no new safety concerns identified.

*based on 1 line=5 approximate ETDRS letters¹
1. Gregori NZ, Feuer W, Rosenfeld PJ. Novel method for analyzing Snellen visual acuity measurements. Retina 2010;30:1046-1050

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

 

BCVA=best corrected visual acuity; SEM=standard error of the mean;DEX=dexamethasone intravitreal implant; ^‡based on 1 line=5 letters¹; *primary endpoint

 

CRT=central retinal thickness; SEM=standard error of the mean; patient n numbers for each data point are in parentheses