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

NCT01698788 | Completed

• 1 other identifier: dr.poojabansal
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Diabetic Macular Edema; Vision Disorders

Keywords

diabetic macular edema; taut posterior hyaloid membrane; ozurdex

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• change in visual acuity

  Baseline to 3 months

Study Arms (2)

TPHM removal without ozurdex

EXPERIMENTAL

Comparison of taut posterior hyaloid removal with (Group B)and without intraoperative ozurdex(Group A)

Drug: Dexamethasone Drug delivery system (Ozurdex)

TPHM removal with ozurdex

EXPERIMENTAL

Comparison of TPHM removal with (Group B) and without (Group A)Ozurdex

Drug: Dexamethasone Drug delivery system (Ozurdex)

Interventions

Dexamethasone Drug delivery system (Ozurdex) DRUG

It is a sustained release intravitreal implant containing 700µg dexamethasone

Also known as: OZURDEX

TPHM removal with ozurdex; TPHM removal without ozurdex

Eligibility Criteria

• Age: 60 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Known case of ocular hypertension or glaucoma
• Macular ischemia on FFA

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Pooja Bansal

Chandigarh, Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Vision Disorders

Interventions

Calcium Dobesilate

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• POOJA BANSAL, MBBS,MS

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

• VISHALI R GUPTA, MBBS,MS

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

• AMOD GUPTA, MBBS,MS

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 22, 2012
• First Posted: October 3, 2012
• Study Start: May 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: February 1, 2012
• Last Updated: October 3, 2012

Record last verified: 2012-09

Locations

IN (1)