Effect of Intraoperative Dexamethasone Implant in Taut Posterior Hyaloid Removal in Diabetic Macular Edema
Status:
Completed
Trial end date:
2012-02-01
Target enrollment:
Participant gender:
Summary
This study is undertaken to determine effect of sustained release dexamethasone
implant,Ozurdex in improving outcome of taut posterior hyaloid removal in patients with
diabetic macular edema
Diabetic macular edema constitute important cause of visual impairment in patients with
diabetes.Focal/ grid laser photocoagulation is the standard of care in the management .
Several adjuncts including intravitreal corticosteroids, Pegaptanib Sodium , Ranibizumab ,
Bevacizumab are also been tried.In some patients inspite of multiple lasers or injections
macular edema persists as a consequence overlying taut posterior hyaloid membrane which needs
to be removed by vitrectomy. Visual improvement after vitrectomy is related to the duration
of edema, as well as the extent of intraretinal lipid and vascular nonperfusion.Even after
surgery some patients might need repeat intravitreal bevacizumab or triamcinolone injections
to take care of residual macular edema.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 because of its short half life . In search for the ideal corticosteroid
preparation, a Dexamethasone Posterior Segment Drug Delivery System (Dexamethasone DDS -
Ozurdex®, Allergan Inc, Irvine, California) was recently developed which has generated new
interest in this molecule. It is a sustained release intravitreal implant containing 700µg
dexamethasone has been approved by the US-FDA (Food and Drug Administration) for treatment of
macular edema in retinal vein occlusions. The present study introduces a novel concept of
using intraoperative Ozurdex ® implant during taut posterior hyaloid removal and its effect
in improving the surgical outcome
Phase:
N/A
Details
Lead Sponsor:
Postgraduate Institute of Medical Education and Research