Effect of Intraoperative Dexamethasone Implant in Taut Posterior Hyaloid Removal in Diabetic Macular Edema

Diabetic Macular Edema Clinical Trial

Official title:

Role of Intraoperative Dexamethasone Implant in Improving Outcome of Taut Posterior Hyaloid Removal in Diabetic Macular Edema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01698788
• Other study ID #: dr.poojabansal
• Status: Completed
• Phase: N/A
• First received: March 22, 2012
• Last updated: September 29, 2012
• Start date: May 2011
• Est. completion date: February 2012

Study information

• Verified date: September 2012
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: February 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema
• Vision Disorders

Intervention

Drug:
• Dexamethasone Drug delivery system (Ozurdex)
It is a sustained release intravitreal implant containing 700µg dexamethasone

Locations

Country	Name	City	State
India	Pooja Bansal	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in central macular thickness	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	Baseline to 3 months	No
Secondary	change in visual acuity	Change in the visual acuity as measured by the logMAR visual acuity chart	Baseline to 3 months	No