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

Information source: Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetic Macular Edema; Macular Edema, Cystoid; Vision Disorders; Clinically Significant Macular Edema

Intervention: long acting intravitreal dexamethasone implant (Drug)

Phase: N/A

Status: Completed

Sponsored by: Postgraduate Institute of Medical Education and Research

Official(s) and/or principal investigator(s):
POOJA BANSAL, MBBS,MS, Principal Investigator, Affiliation: Postgraduate Institute of Medical Education and Research
VISHALI R GUPTA, MBBS,MS, Principal Investigator, Affiliation: Postgraduate Institute of Medical Education and Research
AMOD GUPTA, MBBS,MS, Principal Investigator, Affiliation: Postgraduate Institute of Medical Education and Research

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.

Clinical Details

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

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: change in central macular thickness

Secondary outcome: Change in the visual acuity

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.

Eligibility

Minimum age: 20 Years. Maximum age: 72 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Pooja Bansal, Chandigarh 160012, India
Additional Information

Starting date: December 2011
Last updated: September 29, 2012

Page last updated: August 20, 2015

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