Effect of Intraoperative Dexamethasone Implant in Taut Posterior Hyaloid Removal in 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:
NCT01698788
First received: March 22, 2012
Last updated: September 29, 2012
Last verified: September 2012

March 22, 2012
September 29, 2012
May 2011
December 2011   (final data collection date for primary outcome measure)
change in central macular thickness [ Time Frame: Baseline to 3 months ] [ Designated as safety issue: No ]
The primary outcome measure is the change in the central macular thickness, either an increase or decrease, as measured by optical coherence tomography as compared to the preoperative thickness
Same as current
Complete list of historical versions of study NCT01698788 on ClinicalTrials.gov Archive Site
change in visual acuity [ Time Frame: Baseline to 3 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 Intraoperative Dexamethasone Implant in Taut Posterior Hyaloid Removal in Diabetic Macular Edema
Role of Intraoperative Dexamethasone Implant in Improving Outcome of Taut Posterior Hyaloid Removal in Diabetic Macular Edema

This study is undertaken to determine effect of sustained release dexamethasone implant,Ozurdex in improving outcome of taut posterior hyaloid removal in patients with diabetic macular edema

Diabetic macular edema constitute important cause of visual impairment in patients with diabetes.Focal/ grid laser photocoagulation is the standard of care in the management . Several adjuncts including intravitreal corticosteroids, Pegaptanib Sodium , Ranibizumab , Bevacizumab are also been tried.In some patients inspite of multiple lasers or injections macular edema persists as a consequence overlying taut posterior hyaloid membrane which needs to be removed by vitrectomy. Visual improvement after vitrectomy is related to the duration of edema, as well as the extent of intraretinal lipid and vascular nonperfusion.Even after surgery some patients might need repeat intravitreal bevacizumab or triamcinolone injections to take care of residual macular edema.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 because of its short half life . In search for the ideal corticosteroid preparation, a Dexamethasone Posterior Segment Drug Delivery System (Dexamethasone DDS - Ozurdex®, Allergan Inc, Irvine, California) was recently developed which has generated new interest in this molecule. It is a sustained release intravitreal implant containing 700µg dexamethasone has been approved by the US-FDA (Food and Drug Administration) for treatment of macular edema in retinal vein occlusions. The present study introduces a novel concept of using intraoperative Ozurdex ® implant during taut posterior hyaloid removal and its effect in improving the surgical outcome

This study is undertaken to determine effect of sustained release dexamethasone implant,Ozurdex in improving outcome of taut posterior hyaloid removal in patients with diabetic macular edema

Diabetic macular edema constitute important cause of visual impairment in patients with diabetes.Focal/ grid laser photocoagulation is the standard of care in the management .Several adjuncts including intravitreal corticosteroids, Pegaptanib Sodium , Ranibizumab , Bevacizumab are also been tried.In some patients inspite of multiple lasers or injections macular edema persists as a consequence overlying taut posterior hyaloid membrane which needs to be removed by vitrectomy. The exact role of vitreous in the pathogenesis of diabetic maculopathy remains unclear although it has been implicated as a cause of macular edema via several mechanical and physiologic mechanisms, which include the following (1) destabilization of the vitreous by abnormal glycation and crosslinking of vitreal collagen, leading to traction on the macula, (2) accumulation and concentration of factors causing vasopermeability in the premacular vitreous gel and (3) accumulation of chemoattractant factors in the vitreous, leading to cellular migration to the posterior hyaloid, contraction and macular traction. The observation that release of mechanical traction on the macula with subsequent reduction in DME, either by spontaneous posterior vitreous detachment or with vitrectomy, lends support to this line of reasoning. Furthermore, the evidence that vitrectomy produces improved retinal oxygenation taken together with the evidence that increased oxygenation can reduce DME, suggests an additional physiologic advantage but determination of which eyes might benefit from vitrectomy is the most challenging aspect in the treatment of this condition. Fluorescein angiography, B-scan ultrasonography, and optical coherence tomography may be helpful in this regard. Most often, vitreous surgery is performed when diabetic macular edema persists despite multiple laser treatments. All reports published to date regarding vitrectomy for diabetic macular edema are uncontrolled and nonrandomized patient series. Visual improvement after vitrectomy is related to the duration of edema, as well as the extent of intraretinal lipid and vascular nonperfusion.Even after surgery some patients might need repeat intravitreal bevacizumab or triamcinolone injections to take care of residual macular edema.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 because of its short half life . In search for the ideal corticosteroid preparation, a Dexamethasone Posterior Segment Drug Delivery System (Dexamethasone DDS - Ozurdex®, Allergan Inc, Irvine, California) was recently developed which has generated new interest in this molecule. It is a sustained release intravitreal implant containing 700µg dexamethasone has been approved by the US-FDA (Food and Drug Administration) for treatment of macular edema in retinal vein occlusions. The present study introduces a novel concept of using intraoperative Ozurdex ® implant during taut posterior hyaloid removal and its effect in improving the surgical outcome

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetic Macular Edema
  • Vision Disorders
Drug: Dexamethasone Drug delivery system (Ozurdex)
It is a sustained release intravitreal implant containing 700µg dexamethasone
Other Name: OZURDEX
  • Experimental: TPHM removal without ozurdex
    Comparison of taut posterior hyaloid removal with (Group B)and without intraoperative ozurdex(Group A)
    Intervention: Drug: Dexamethasone Drug delivery system (Ozurdex)
  • Experimental: TPHM removal with ozurdex
    Comparison of TPHM removal with (Group B) and without (Group A)Ozurdex
    Intervention: Drug: Dexamethasone Drug delivery system (Ozurdex)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
February 2012
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Type 1 or 2 Diabetes mellitus
  2. TPHM causing cystoid macular edema with or without subfoveal serous RD on OCT

Exclusion Criteria:

  1. Known case of ocular hypertension or glaucoma
  2. Macular ischemia on FFA
Both
60 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01698788
dr.poojabansal
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