June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
DEXAMETHASONE IMPLANT (OZURDEX) FOR DIABETIC MACULAR EDEMA IN NAÏVE COMPARED TO REFRACTORY CASES: A RETROSPECTIVE 24 MONTHS STUDY
Author Affiliations & Notes
  • Matias Iglicki
    University of Buenos Aires, City of Buenos Aires, Argentina
  • Dinah Zur
    Divsion of Ophthalmology , Sourasky Medical Center , Sackler Faculty of Medicine , TEL AVIV , TEL AVIV, Israel
  • Carolina Colutta
    Ophthalmology, Institute of Ophthalmolgy , Buenos aires, buenos aires, Argentina
  • Ines Lains
    Massachuser Eye and Ear, Harvard Medical School , Boston, Massachusetts, United States
  • Hermino Pablo Negri
    Ophthalmology , Diagnostic Ophthalmology center , Buenos Aires , Buenos Aires, Argentina
  • Footnotes
    Commercial Relationships   Matias Iglicki, None; Dinah Zur, None; Carolina Colutta , None; Ines Lains, None; Hermino Negri, None
  • Footnotes
    Support  none
Investigative Ophthalmology & Visual Science June 2017, Vol.58, 1910. doi:
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      Matias Iglicki, Dinah Zur, Carolina Colutta, Ines Lains, Hermino Pablo Negri; DEXAMETHASONE IMPLANT (OZURDEX) FOR DIABETIC MACULAR EDEMA IN NAÏVE COMPARED TO REFRACTORY CASES: A RETROSPECTIVE 24 MONTHS STUDY. Invest. Ophthalmol. Vis. Sci. 2017;58(8):1910.

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

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Abstract

Purpose : The purpose of this study was to assess the effect of dexamethasone (DEX) implant 0.7 mg (Ozurdex™) in eyes with treatment-naïve diffuse diabetic macular edema (DME) compared to cases refractory to anti-VEGF treatments. Diabetic macular edema (DME) is a leading cause of vision loss and blindness, characterized by capillary leakage, fluid accumulation, and retinal thickening. Dexamethasone (DEX) intravitreal implant is a biodegradable implant, providing sustained release into the vitreous for up to 6 months.

Methods : A restropective study was conducted on eyes with naïve DME and eyes with DME refractory to at least 3 consecutive anti-VEGF injections that received a DEX implant (±photocoagulation). Patients were included with following criteria before treatment: Best corrected visual acuity (BCVA) of 15-72 ETDRS letters, central macular thickness (CMT) >300 µm and intraocular pressure (IOP) <25 mm Hg. After treatment with the DEX implant (±photocoagulation), BCVA, CMT and total macular volume (TMV) were assessed monthly for 6 months and then every 4 months until the end of the study.The predefined primary efficacy endpoint for the FDA was achievement of ≥15-letter improvement in BCVA from baseline to study end in each group. Safety measures included adverse events and intraocular pressure (IOP).

Results : 96 eyes with DME of 96 patients (60 naïve; 36 refractory) were included.The percentage of patients with ≥15-letter improvement in BCVA was 35 % overall (50 % for naïve and 20% for refractory). At every visit, BCVA improved significantly from baseline in both groups (p < 0.001), but values were significantly better in the naïve group. Mean average reduction in CRT standard deviation was 120 ±20 μm. CMT and TMV decreased significantly (p < 0.001) and similarly in both groups.40% of phakic eyes developed cataract. IOP increased by 20% from baseline. Only 1 patient needed trabeculectomy.The naïve group needed less photocoagulations (p = 0.001). Mean number of treatments received over 2 years was 3 DEX implants

Conclusions : DEX implant causes substantial anatomical and functional improvement in naïve and refractory DME. However, the benefit was greater in the treatment-naïve group. Further prospective studies are needed in order to determine the role of DEX implant in the treatment algorithm of DME.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.

 

 

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