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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pooja Bansal,MD, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:
NCT01698749
First received: March 22, 2012
Last updated: September 29, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention
Diabetic Macular Edema
Macular Edema, Cystoid
Vision Disorders
Clinically Significant Macular Edema
 Drug: long acting intravitreal dexamethasone implant

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Intravitreal Long Acting Dexamethasone Implant, Ozurdex in Patients With Diabetic Macular Edema

Resource links provided by NLM:

MedlinePlus related topics: Edema Steroids
U.S. FDA Resources

Further study details as provided by Postgraduate Institute of Medical Education and Research:

Primary Outcome Measures:
  • change in central macular thickness [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    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:
  • Change in the visual acuity [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Change in the visual acuity as measured by the logMAR visual acuity chart


Enrollment: 61
Study Start Date: December 2011
Study Completion Date: February 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ozurdex in diabetic macular edema
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
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
Other Name: Ozurdex

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

Ages Eligible for Study:   20 Years to 72 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01698749

Locations
India
Pooja Bansal
Chandigarh, India, 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
Principal Investigator: POOJA BANSAL, MBBS,MS Postgraduate Institute of Medical Education and Research
Principal Investigator: VISHALI R GUPTA, MBBS,MS Postgraduate Institute of Medical Education and Research
Principal Investigator: AMOD GUPTA, MBBS,MS Postgraduate Institute of Medical Education and Research
  More Information

No publications provided

Responsible Party: Pooja Bansal,MD, MD, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT01698749     History of Changes
Other Study ID Numbers: PoojaBansal 13
Study First Received: March 22, 2012
Last Updated: September 29, 2012
Health Authority: India: Ministry of Health

Keywords provided by Postgraduate Institute of Medical Education and Research:
Ozurdex
Diabetic macular edema
Central macular thickness

Additional relevant MeSH terms:
Edema
Macular Edema
Vision Disorders
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
 Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors

ClinicalTrials.gov processed this record on June 13, 2013