Effect of Intraoperative Dexamethasone Implant in Taut Posterior Hyaloid Removal in Diabetic Macular Edema

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Postgraduate Institute of Medical Education and Research
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

Inclusion Criteria:

1. Type 1 or 2 Diabetes mellitus

2. TPHM causing cystoid macular edema with or without subfoveal serous RD on OCT

Exclusion Criteria:

1. Known case of ocular hypertension or glaucoma

2. Macular ischemia on FFA