September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Real-World Assessment of Dexamethasone Intravitreal Implant in Diabetic Macular Edema: Interim Analysis from the REINFORCE Study
Author Affiliations & Notes
  • Howard F Fine
    Rutgers UMDNJ Dept Ophthalmology, NJ Retina, New Brunswick, New Jersey, United States
  • Michael Singer
    University of Texas Health Science Center, San Antonio, Texas, United States
  • Pravin U Dugel
    Retinal Consultants of Arizona , Phoenix, Arizona, United States
  • Antonio Capone, Jr.
    Associated Retinal Consultants, Royal Oak, Michigan, United States
  • John Maltman
    Allergan plc, Irvine, California, United States
  • Footnotes
    Commercial Relationships   Howard Fine, Allergan (F), Allergan (C), Allergan (R), Auris Surgical Robotics (I), Auris Surgical Robotics (P), Genentech (F), Genentech (C), Genentech (R), Regeneron (F), Regeneron (C), Regeneron (R); Michael Singer, Allegro Ophthalmics (F), Allergan plc (F), Allergan plc (C), Allergan plc (R), Ampio Pharmaceuticals (F), Genetech (F), Genetech (C), Genetech (R), Neurotech Pharmaceuticals (F), Ophthotech (F), Pfizer (F), Regeneron (F), Regeneron (R), Santen Pharmaceutical Co. (F); Pravin Dugel, Abbott/AMO (C), Acucela, Lux BioScience (C), Aerpio (I), Aerpio (C), Alimera Sciences, Digisight (C), Allergan plc, Opthea, Optovue (C), Allimera Sciences (I), Annidis (I), Annidis, Lutronic (C), ArcticAx, OD-OS (C), AvaAlanche Biotechnologies, Omeros (C), Clearside Biomedical, Ophthotech (C), Digisight, DOSE Medical, Pentavision, (C), DOSE Medical, Thrombogenics (C), Genentech, Roche, TopCon (C), Neurotech (I), Novartis, Alcon (C), Ophthotech (I), Regeneron, ORA, Stealth BioTherapeutics (C), TrueVision (I); Antonio Capone, Jr., Acucela (F), Allergan (S), Allergan plc (R), Allergan plc (C), Allergan plc (S), FocusROP (S), FocusROP (I), Genentech (F), Novartis (C), Retinal Solutions (P), Retinal Solutions (S), Retinal Solutions (I), Roche (F), Spark (C), Synergetics (C); John Maltman, Allergan plc (E)
  • Footnotes
    Support  Allergan
Investigative Ophthalmology & Visual Science September 2016, Vol.57, 3259. doi:
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      Howard F Fine, Michael Singer, Pravin U Dugel, Antonio Capone, Jr., John Maltman; Real-World Assessment of Dexamethasone Intravitreal Implant in Diabetic Macular Edema: Interim Analysis from the REINFORCE Study. Invest. Ophthalmol. Vis. Sci. 2016;57(12):3259.

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

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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

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

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

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