Steroid eye drop treatment (difluprednate ophthalmic emulsion) is effective in reducing refractory diabetic macular edema.

Abstract

PURPOSE:

To evaluate the efficacy of treatment of refractory diabetic macular edema (DME) after vitrectomy with difluprednate ophthalmic emulsion 0.05% (Durezol(TM)), and to compare this treatment with sub-Tenon's injection of triamcinolone (STTA).

METHODS:

This study enrolled patients with refractory diabetic macular edema that persisted despite pars plana vitrectomy in our clinic. In all subjects, more than 3 months had passed since prior treatment. Eleven eyes in ten subjects were treated with STTA (STTA group), and 11 eyes in seven subjects were treated with difluprednate ophthalmic emulsion 0.05% (Durezol(TM), Sirion Therapeutics Inc., USA) 4 times daily for the first month and then twice daily for 2 months (eye drop group).

RESULTS:

In the eye drop group, mean VA (+/- SD) was 0.67 +/- 0.35 logMAR and mean retinal thickness was 500.6 +/- 207.7 mum at baseline. After 3 months of treatment, mean VA was 0.67 +/- 0.29 and mean retinal thickness had decreased to 341.2 +/- 194.8 mum. The mean minimum value of RT during the treatment period was 300.6 +/- 123.2 mum, and significantly lower than that at baseline (Mann-Whitney U test: P = 0.003). In the STTA group, mean VA (+/- SD) was 0.67 +/- 0.35 logMAR, and mean retinal thickness was 543.3 +/- 132.6 mum at baseline. After 3 months of treatment, mean VA was 0.49 +/- 0.67, and mean retinal thickness had decreased to 378.6 +/- 135 mum. The mean minimum value of RT during the treatment period was 349.9 +/- 113.8 mum, and significantly lower than at baseline (Mann-Whitney U test: P = 0.003). The rate of effective improvement in RT did not differ between the eye drop group (73%) and STTA group (84%) (Fisher's exact test: P = 1).

CONCLUSIONS:

Comparable improvements of retinal thickness were observed in the STTA and eye drop groups. Instillation of difluprednate ophthalmic emulsion 0.05% is a safe and effective treatment that does not require surgical intervention and does not produce severe side-effects.

• Authors: Sakiko Nakano, Teiko Yamamoto, Eriko Kirii, Sachi Abe, Hidetoshi Yamashita
• Journal: Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie (Graefes Arch Clin Exp Ophthalmol) Vol. 248 Issue 6 Pg. 805-10 (Jun 2010) ISSN: 1435-702X [Electronic] Germany
• PMID: 20180131 (Publication Type: Comparative Study, Journal Article)

Chemical References

• Emulsions
• Glucocorticoids
• Ophthalmic Solutions
• Fluprednisolone
• Triamcinolone Acetonide
• difluprednate

Topics

• Diabetic Retinopathy (drug therapy, surgery)
• Emulsions
• Female
• Fluprednisolone (adverse effects, analogs & derivatives, therapeutic use)
• Glucocorticoids (adverse effects, therapeutic use)
• Humans
• Injections
• Macular Edema (drug therapy, surgery)
• Male
• Middle Aged
• Ophthalmic Solutions (adverse effects, therapeutic use)
• Tomography, Optical Coherence
• Treatment Outcome
• Triamcinolone Acetonide (therapeutic use)
• Visual Acuity (physiology)
• Vitrectomy