Clinical Need - Iluvien : Iluvien

Persistent diabetic macular edema (DME) is DME that persists or recurs despite treatment¹

Persistent DME was seen in up to 65.6% of eyes treated for DME through the 24-week visit despite a rigorous protocol in a post-hoc analysis of Protocol T¹^,a,b

The persistent DME cohort included 546 eyes that received anti-VEGF treatments in this major clinical trial
Persistent DME was defined as central subfield thickness (CST) of at least 250 microns at each completed study visit through week 24

Review Study Design

Protocol T post-hoc data: Percent of patients with persistent DME through 24 weeks

^aFrom baseline to week 20, all patients received injection drug every 4 weeks unless CST was < 250 microns and VA letter score was ≥ 84 after 2 consecutive 4-week injections. After the initial 20 weeks, injections were continued every 4 weeks if VA letter score was < 84 (worse than 20/20) AND CST was > 250 microns.
^bExclusion criteria for Protocol T: Baseline CST < 250 microns, less than 4 injections prior to week 24, missed week 24, missed 2 or more visits between week 28 and 52, or received alternative treatment for DME prior to week 52.

Compared to patients in major clinical trials, patients in clinical practice were monitored less frequently and received far fewer injections in a large retrospective claims analysis²

Mean number of visits with anti-VEGF injection for all DME cohorts was 3.0 per year
Less than 6% of patients received ≥ 10 injections in 12 months in actual clinical practice

Review Study Design

Mean number of visits to all doctors and ophthalmologists by patients with DME in 12 months

Claims from large-scale health plan database for 2008-2010 and covering 64 million unique patients (80 health plans).

Persistent DME has a negative impact on long-term visual acuity (VA)

Patients with persistent DME may have limited visual gains despite ultimately achieving similar retinal thickness outcomes, as demonstrated in anti-VEGF Phase 3 clinical trials (RISE and RIDE)³

Patients initially randomized to the control group were switched to monthly ranibizumab after month 24 and eventually achieved similar retinal thickness outcomes, but did not have the same visual acuity gains

Review Study Design

RISE and RIDE pooled data: Mean change in CST

A second Phase 3 clinical trial program (VIVID and VISTA) in DME demonstrated independently that patients with persistent DME may have limited visual gains despite ultimately achieving similar retinal thickness outcomes⁴

Patients initially randomized to the control group were switched to monthly aflibercept treatment at 100 weeks and eventually achieved similar retinal thickness outcomes but did not have the same visual acuity gains

Review Study Design

RISE and RIDE pooled data: Mean change in BCVA