Intraoperative Dexamethasone Implant Improves Outcome of Cataract Surgery With Diabetic Macular Edema

June 17, 2014 updated by: Aniruddha Agarwal, MD, Postgraduate Institute of Medical Education and Research

Intraoperative Dexamethasone Implant (Ozurdex®) Improves Outcome of Cataract Surgery in Patients With Diabetic Macular Edema

This study is undertaken to determine the effect of intravitreal long acting dexamethasone implant, (Ozurdex®) in improving outcome of cataract surgery in patients with diabetic macular edema.

Diabetic Macular Edema and cataract constitute important causes of visual impairment in patients with diabetes. Cataract surgery in patients with diabetic retinopathy is associated with progression of retinopathy.

Several modalities such as non-steroidal anti-inflammatory agents, carbonic anhydrase inhibitors, corticosteroids, hyperbaric oxygen, laser photocoagulation and vitrectomy with internal limiting membrane peeling have been tried for managing inflammatory cystoid 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 as the patients need multiple repeat injections.

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 persistent diabetic macular edema receiving this intravitreal drug delivery system with improvement in visual acuity

The present study introduces a novel concept of using intraoperative Ozurdex ® implant in patients with diabetes mellitus while undergoing cataract surgery to minimize the worsening of diabetic maculopathy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Diabetic Macular Edema (DME) and cataract constitute important causes of visual impairment in patients with diabetes mellitus. Cataract surgery in patients with diabetic retinopathy is associated with progression of both retinopathy and maculopathy in nearly 23-57% of cases, thus affecting the final visual outcome. Post-cataract surgery, macular edema may be due to worsening/presence of pre-existing clinically significant macular edema (CSME) or due to development of Irvine Gass Syndrome where cystoid macular edema (CME) occurs in the post operative period and is believed to be inflammatory in origin. Focal/ grid laser photocoagulation is the standard of care in the management of CSME, which may be pre-existing at the time of cataract surgery or worsens following surgery. Several adjuncts including intravitreal corticosteroids, Pegaptanib Sodium (Macugen; Pfizer, New York), Ranibizumab (Lucentis; Genentech, South San Francisco, California), Bevacizumab (Avastin, Genentech) have been tried in an attempt to improve the visual results.

Several modalities such as non-steroidal anti-inflammatory agents, carbonic anhydrase inhibitors, corticosteroids, hyperbaric oxygen, laser photocoagulation and vitrectomy with internal limiting membrane peeling have been tried for managing inflammatory cystoid macular edema13. Intravitreal Triamcinolone Acetonide (TA), a water insoluble steroid, has been shown to reduce the retinal thickness and improve the visual acuity14-16. However, recurrence of macular edema in patients who receive intravitreal TA is a major concern as the patients need multiple repeat injections because of the short half life of the drug (18.6 days). 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 (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. Promising results have been shown in certain patients with persistent diabetic macular edema receiving this intravitreal drug delivery system with improvement in visual acuity.

The present study introduces a novel concept of using intraoperative Ozurdex ® implant in patients with diabetes mellitus while undergoing cataract surgery to minimize the worsening of diabetic maculopathy.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Chandigarh, India, 160012
        • Postgraduate Institute of Medical Education and Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

  1. Presence of visually significant cataract requiring surgery (any grade)
  2. Patients with Non-proliferative Diabetic Retinopathy (NPDR) with/without clinically significant macular edema (CSME)
  3. Patients with Proliferative Diabetic Retinopathy (PDR) with/without CSME where proliferative component has been adequately treated with laser photocoagulation.

All patients fulfilling criteria 1 with 2 or 3 shall be enrolled in the study. The patients of either sex up to the age of 60 years would be included for the study.

Exclusion Criteria:

The following would be the exclusion criteria:

  • Presence of untreated proliferative diabetic retinopathy
  • Patients with history of ocular hypertension or glaucoma
  • Presence of associated conditions that may exacerbate macular edema, i.e. uveitis, retinal vein occlusions, neovascular glaucoma
  • History of use of drugs such as prostaglandin analogues, adrenaline or nicotinic acid
  • Patients with post-operative media haze or pupillary non-dilation that does not allow good fundus photography, Fundus Fluorescein Angiography (FFA) and Optical Coherence Tomography (OCT).
  • Patients who develop any intraoperative complication including posterior capsular rent, vitreous loss, zonular dehiscence, etc shall be excluded from the study in both the groups

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phacoemulsification with IOL implant
This group (Group B) includes patients who will undergo phacoemulsification with intraocular lens implantation. The dexamethasone implant will not be injected at the beginning of cataract surgery. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.
Procedure: Cataract surgery
Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.
Other Names:
  • Phacoemulsification
Experimental: Phacoemulsification with Ozurdex
This group (Group A) includes patients who will undergo phacoemulsification with intraocular lens implantation with intraoperative long acting steroid injection (Ozurdex ®). The dexamethasone implant will be injected at the beginning of cataract surgery, 4mm from the limbus using the specially designed injector. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.
Drug: Dexamethasone Drug delivery system (Ozurdex)
It is a sustained release intravitreal implant containing 700µg dexamethasone has been approved by the US-FDA (Food and Drug Administration).
Other Names:
  • Ozurdex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the 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 the preoperative thickness.
Baseline and 6 MONTHS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Visual Acuity
Time Frame: Difference in number of letters read (6 months minus baseline)
Change in the visual acuity as measured by the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity scale (number of letters at 6 months - number of letters at baseline) The number of letters read on the ETDRS scale will be measured, with 0 being the worst and 35 being the best
Difference in number of letters read (6 months minus baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Postgraduate Institute of Medical Education and Research

Investigators

  • Principal Investigator: Vishali R Gupta, MBBS MS, Postgraduate Institute of Medical Education and Research
  • Principal Investigator: ANIRUDDHA K AGARWAL, MBBS, Postgraduate Institute of Medical Education and Research
  • Principal Investigator: Jagat Ram, MBBS MS, Postgraduate Institute of Medical Education and Research
  • Principal Investigator: Amod Gupta, MBBS MS, Postgraduate Institute of Medical Education and Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

March 2, 2012

First Submitted That Met QC Criteria

March 6, 2012

First Posted (Estimate)

March 7, 2012

Study Record Updates

Last Update Posted (Estimate)

June 18, 2014

Last Update Submitted That Met QC Criteria

June 17, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • aniruddha9

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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