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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

March 22, 2012
September 29, 2012
December 2011
January 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01698749 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Effect of Intravitreal Long Acting Dexamethasone Implant, Ozurdex in Patients With Diabetic Macular Edema
Effect of Intravitreal Long Acting Dexamethasone Implant, Ozurdex in Patients With Diabetic Macular Edema

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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetic Macular Edema
  • Macular Edema, Cystoid
  • Vision Disorders
  • Clinically Significant Macular Edema
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
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
Intervention: Drug: long acting intravitreal dexamethasone implant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
February 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
20 Years to 72 Years
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01698749
PoojaBansal 13
No
Pooja Bansal,MD, Postgraduate Institute of Medical Education and Research
Postgraduate Institute of Medical Education and Research
Not Provided
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
Postgraduate Institute of Medical Education and Research
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP