Effect of Intravitreal Long Acting Dexamethasone Implant, Ozurdex in Patients With Diabetic Macular Edema
Status:
Completed
Trial end date:
2012-02-01
Target enrollment:
Participant gender:
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.
Phase:
N/A
Details
Lead Sponsor:
Postgraduate Institute of Medical Education and Research