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Diabetic Macular EdemaNCT01698788

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

A study testing Dexamethasone Drug delivery system (Ozurdex) in people with Diabetic Macular Edema and Vision Disorders, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 60 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Diabetic Macular Edema, Vision Disorders
What is being tested?
Dexamethasone Drug delivery system (Ozurdex)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteIndia
Study dates
May 2011to Feb 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

India1 site
  • Pooja Bansal

    Chandigarh, Chandigarh, 160012

Other trials in India

About this study

Official title: 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

Read the detailed 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

Being tested
Dexamethasone Drug delivery system (Ozurdex)
Keywords
diabetic macular edema, taut posterior hyaloid membrane, ozurdex
Medical subject headings
Vision Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dexamethasone Drug delivery system (Ozurdex)Drug

    Also called OZURDEX

    It is a sustained release intravitreal implant containing 700µg dexamethasone

Study groups in NCT01698788
Study groupRoleWhat they receive
TPHM removal without ozurdexExperimentalComparison of taut posterior hyaloid removal with (Group B)and without intraoperative ozurdex(Group A)
Receives: Drug: Dexamethasone Drug delivery system (Ozurdex)
TPHM removal with ozurdexExperimentalComparison of TPHM removal with (Group B) and without (Group A)Ozurdex
Receives: Drug: Dexamethasone Drug delivery system (Ozurdex)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline to 3 months

Secondary outcomes (1)
  1. change in visual acuity

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

    Measured: Baseline to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2012 (estimated)
  2. Study startMay 2011
  3. Primary completionDec 2011
  4. Study completionFeb 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01698788
Sponsor's protocol ID
dr.poojabansal
Status last verified
Sep 2012
First submitted
22 Mar 2012
Last updated
3 Oct 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Dexamethasone Drug delivery system (Ozurdex) in people with Diabetic Macular Edema and Vision Disorders, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in central macular thickness (time frame: Baseline to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2012.

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