Abstract
Purpose :
Patients with diabetes and diabetic macular edema (DME) have significantly higher rates of common comorbidities and ocular comorbidities (Kiss, 2014; Kiss, 2016). Retrospective claims analyses have shown a reduction in the frequency of anti-VEGF therapies for DME in the real world. This leads to results that are not replicated in randomized clinical trials. This analysis of DME treatment burden pre- and post-0.2 μg/day fluocinolone acetonide (FAc) implant aims to determine whether use of a continuous microdosing implant optimizes therapy and reduces the DME treatment burden.
Methods :
The PALADIN study compares real-world data on treatment frequency and outcomes with up to 36 months’ pre-FAc implant in patients with DME. Treatment burden was evaluated by baseline visual acuity (VA) subgroups to compare differences in treatment frequency by severity of VA deficit. These results were compared with previously published data from the US commercial payer database and another real-world study (USER) involving FAc implants in patients with DME.
Results :
In PALADIN and USER, patients received ~1 treatment every 3 months prior to 0.2 µg/day FAc regardless of baseline VA. This mirrors the real-world study by Kiss (2016) in which patients received 1 intravitreal injection every 3.1 months. Post-FAc implants, the frequency of DME treatments was significantly reduced in the overall population in both (USER: 1 treatment every 2.9 months vs every 14.3 months, p<0.001; PALADIN: 1 treatment every 3.7 months vs every 7.9 months, p<0.001).
Conclusions :
Across three independent datasets capturing real-world treatment frequency for DME, patients received 1 treatment every ~3.5 months regardless of VA deficit. This similarity in treatment frequency irrespective of VA deficit represents a ‘ceiling effect’ in delivery of real-world intravitreal therapy for DME. The change in treatment frequency post-FAc implants represents both a reduction in treatment burden and a true customization of therapy according to VA deficit.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.