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NCT Number: NCT01698749

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.

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Key information

Conditions

Diabetic Macular Edema Clinically Significant Macular Edema Eye Diseases Macular Degeneration Macular Edema Macular Edema, Cystoid Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases Sensation Disorders Signs and Symptoms Vision Disorders

Age range

20 year–72 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pooja Bansal

Chandigarh, 160012, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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

Other names: Ozurdex

Primary outcomes

  1. change in central macular thickness

    Time frame: 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 outcomes

  1. Change in the visual acuity

    Time frame: Baseline and 6 months

    Change in the visual acuity as measured by the logMAR visual acuity chart

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 3, 2012
Registry last updated
Oct 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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