July 2018
Volume 59, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2018
Treatment burden associated with intravitreal injections in the real world: PALADIN Phase 4 trial with fluocinolone acetonide 0.2 µg/day
Author Affiliations & Notes
  • Michael Singer
    Med Ctr Ophthalmology Assoc, San Antonio, Texas, United States
  • Footnotes
    Commercial Relationships   Michael Singer, Aerpio (R), Aerpio (C), Alcon (F), Alimera (F), Allegro (F), Allergan (C), Ampio (C), Clearside (C), Genentech (C), Genentech (R), Guidepoint (C), Notal Vision (C), Ophthotech (F), Optos (F), Regeneron (R), Santen (C), Santen (R)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science July 2018, Vol.59, 4811. doi:
  • Views
  • Share
  • Tools
    • Alerts
      ×
      This feature is available to authenticated users only.
      Sign In or Create an Account ×
    • Get Citation

      Michael Singer; Treatment burden associated with intravitreal injections in the real world: PALADIN Phase 4 trial with fluocinolone acetonide 0.2 µg/day. Invest. Ophthalmol. Vis. Sci. 2018;59(9):4811.

      Download citation file:


      © ARVO (1962-2015); The Authors (2016-present)

      ×
  • Supplements
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.

 

Table. DME treatment frequency.
*Treatment frequency is pre-0.2 µg/day FAc; intravitreal injections
1Kiss S, et al. Clin Ophthalmol 2014;8:1611–1621; 2Kiss S, et al. Clin Ophthalmol 2016;10:2443–2453

Table. DME treatment frequency.
*Treatment frequency is pre-0.2 µg/day FAc; intravitreal injections
1Kiss S, et al. Clin Ophthalmol 2014;8:1611–1621; 2Kiss S, et al. Clin Ophthalmol 2016;10:2443–2453

×
×

This PDF is available to Subscribers Only

Sign in or purchase a subscription to access this content. ×

You must be signed into an individual account to use this feature.

×