Effect of Intravitreal Long Acting Dexamethasone Implant, Ozurdex in Patients With Diabetic Macular Edema
Condition: Diabetic Macular Edema; Macular Edema, Cystoid; Vision Disorders; Clinically Significant Macular Edema
MeSH terms: Vision Disorders; Macular Edema; Edema
Study type: Interventional

Summary: 
      This study is undertaken to determine the effect of intravitreal long acting dexamethasone
      implant,(Ozurdex®)in patients with diabetic macular edema.Diabetic macular edema is important
      cause of visual impairment in patients with diabetes mellitus. Focal/ grid laser
      photocoagulation is the standard of care in its management. Several adjuncts including
      intravitreal corticosteroids, Pegabtanib Sodium ,Ranibizumab, Bevacizumab, non-steroidal
      anti-inflammatory agents, corticosteroids, laser photocoagulation have been tried.
      Intravitreal Triamcinolone Acetonide (TA), a water insoluble steroid, has been shown to
      reduce the retinal thickness and improve the visual acuity. However, recurrence of macular
      edema in patients who receive intravitreal TA is a major concern as the patients need
      multiple repeat injections because of its short half life. A more potent steroid,
      dexamethasone has also been tried as an alternative to TA for macular edema; however, its
      short half life of only 3 hours prevents its clinical application. In search for the ideal
      corticosteroid preparation, a Dexamethasone Posterior Segment Drug Delivery System
      (Dexamethasone DDS - Ozurdex®, Allergan Inc, Irvine, California) was recently developed.
      Promising results have been shown in certain patients with retinal vein occlusions, uveitis
      receiving this intravitreal drug delivery system with improvement in visual acuity. The
      present study introduces a novel concept of using Ozurdex ® implant in patients with diabetic
      macular edema.
    

Detailed description: 
      This study is undertaken to determine the effect of intravitreal long acting dexamethasone
      implant,(Ozurdex®)in patients with diabetic macular edema.Diabetic macular edema is important
      cause of visual impairment in patients with diabetes mellitus. Focal/ grid laser
      photocoagulation is the standard of care in its management. Several adjuncts including
      intravitreal corticosteroids, Pegabtanib Sodium ,Ranibizumab, Bevacizumab, non-steroidal
      anti-inflammatory agents, corticosteroids, laser photocoagulation have been tried.
      Intravitreal Triamcinolone Acetonide (TA), a water insoluble steroid, has been shown to
      reduce the retinal thickness and improve the visual acuity. However, recurrence of macular
      edema in patients who receive intravitreal TA is a major concern as the patients need
      multiple repeat injections because of its short half life. A more potent steroid,
      dexamethasone has also been tried as an alternative to TA for macular edema; however, its
      short half life of only 3 hours prevents its clinical application. In search for the ideal
      corticosteroid preparation, a Dexamethasone Posterior Segment Drug Delivery System
      (Dexamethasone DDS - Ozurdex®, Allergan Inc, Irvine, California) was recently developed.
      Promising results have been shown in certain patients with retinal vein occlusions, uveitis
      receiving this intravitreal drug delivery system with improvement in visual acuity. The
      present study introduces a novel concept of using Ozurdex ® implant in patients with diabetic
      macular edema.
    

Intervention name(s): long acting intravitreal dexamethasone implant
Intervention type(s): Drug
Intervention description(s): Intravitreal ozurdex was given in diabetic patients with clinically significant macular edema and they were followed up for change in central macular thickness and visual acuity over a period of 6 months
Other intervention name(s): Ozurdex
Intervention MeSH terms: Dexamethasone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ozurdex; Diabetic macular edema; Central macular thickness