Effect of Intravitreal Long Acting Dexamethasone Implant, Ozurdex in Patients With Diabetic Macular Edema

Not Applicable

Completed

• Conditions: Diabetic Macular Edema; Macular Edema, Cystoid; Vision Disorders; Clinically Significant Macular Edema
• Interventions: Drug: long acting intravitreal dexamethasone implant

• Registration Number: NCT01698749
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

Brief 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.

Study Timeline

• Study Start: 2011-12
• Primary Completion: 2012-01
• Study Completion: 2012-02
• Study First Submitted: 2012-03-22
• Status Verified: 2012-09
• Study First Submitted QC: 2012-09-29
• Last Update Submitted: 2012-09-29
• Study First Posted: 2012-10-03
• Last Update Posted: 2012-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

• The patients of Type 1 or Type 2 Diabetes Mellitus fulfilling the following inclusion criteria shall be enrolled in the study:

  1. Patients of Non Proliferative Diabetic retinopathy (NPDR)with clinicaly significant macular edema(CSME)
  2. Patients with Proliferative Diabetic Retinopathy (PDR) with CSME where proliferative component has been adequately treated with laser photocoagulation
  3. Diabetic patients withcystoid macular edema
  4. Minimum central thickness on OCT not less than 300 microns

Exclusion Criteria

1. Patients with history of ocular hypertension or glaucoma
2. Patients with media haze or pupillary non-dilation that does not allow good fundus photography, FFA and OCT.
3. Patients with macular ischemia on FFA

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ozurdex in diabetic macular edema	long acting intravitreal dexamethasone implant	Intravitreal ozurdex given in patients with diabetic macular edema and patients followed up for change in central macular thickness and visual acuity over period of 6 months

Primary Outcome Measures

Name	Time	Method
change in central macular thickness	Baseline and 6 months	The primary outcome is the change in the central macular thickness, either an increase or decrease, as measured by optical coherence tomography as compared to baseline central macular thickness

Secondary Outcome Measures

Name	Time	Method
Change in the visual acuity	Baseline and 6 months	Change in the visual acuity as measured by the logMAR visual acuity chart

Trial Locations

Locations (1)

Pooja Bansal; 🇮🇳 Chandigarh, India