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

NCT01698749 | Completed

• 1 other identifier: PoojaBansal 13
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Macular Edema; Macular Edema, Cystoid; Vision Disorders; Clinically Significant Macular Edema

Keywords

Ozurdex; Diabetic macular edema; Central macular thickness

Outcome Measures

Primary Outcomes (1)

• change in central macular thickness

  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

  Baseline and 6 months

Secondary Outcomes (1)

• Change in the visual acuity

  Baseline and 6 months

Study Arms (1)

Ozurdex in diabetic macular edema

EXPERIMENTAL

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

Drug: long acting intravitreal dexamethasone implant

Interventions

long acting intravitreal dexamethasone implant DRUG

Intravitreal ozurdex was given in diabetic patients with clinically significant macular edema and they were followed up for change in central macular thickness and visual acuity over a period of 6 months

Also known as: Ozurdex

Ozurdex in diabetic macular edema

Eligibility Criteria

• Age: 20 Years - 72 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Pooja Bansal

Chandigarh, Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Macular Edema; Vision Disorders

Interventions

Calcium Dobesilate

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• POOJA BANSAL, MBBS,MS

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

• VISHALI R GUPTA, MBBS,MS

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

• AMOD GUPTA, MBBS,MS

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 22, 2012
• First Posted: October 3, 2012
• Study Start: December 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: February 1, 2012
• Last Updated: October 3, 2012

Record last verified: 2012-09

Locations

IN (1)