Safety and Effectiveness of Ozurdex Steroid Implants for DME After Vitrectomy Surgery

March 3, 2020 updated by: Jeffrey L. Marx, MD, Lahey Clinic

A Randomized, Pilot Study of the Efficacy and Safety of Ozurdex Steroid Implants in Post-Vitrectomized Eyes in Patients With Diabetic Macular Edema

Currently medications injected intravitreally in previously vitrectomized eyes have a very short half-life due to enhanced clearance of the drug. The use of the Ozurdex (dexamethasone) implant may allow sustained levels of steroid delivery to patients with diabetic macular edema that have undergone prior vitrectomy. The sustained steroid levels may lead to improved central retinal thickness measurements and improved visual acuity.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

A total of 15 patients will be enrolled into the study. This is a 3 year randomized controlled study with the primary endpoint at 1 year. Secondary safety and efficacy endpoints will be evaluated in year 2 and year 3.

Patients will be randomly enrolled into 1 of 3 groups:

Group 1: Dexamethasone administered up to every 3 months Group 2: Dexamethasone administered up to every 6 months Group 3: Sham

Patients will be evaluated on a monthly basis with ETDRS visual acuity, intraocular pressure, fundus examination and OCT.

Ozurdex (dexamethasone) or Sham Procedure will be performed on Day 0. All patients will be evaluated monthly thereafter. One month following initial injection/sham, patients will be evaluated for focal or grid laser treatment if the investigator feels the patient will benefit.

Re-implantation of Ozurdex may occur at any time > 3 months following last injection in group 1 and > 6 months following last injection in group 2 if any of the following conditions are met:

  1. Increase of > 50 microns from the best previous CRT measurement
  2. Recurrence of intraretinal cystic edema
  3. Persistent intraretinal cystic edema

At 13 months, patients in the sham group will be eligible for Ozurdex implantation if initial inclusion/exclusion criteria are met. These patients would follow re-implantation guidelines of group 2 (up to every 6 months).

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

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

  • United States
    • Massachusetts
      • Peabody, Massachusetts, United States, 01960
        • Lahey Medical Center, One Essex Center Drive

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Adults> 18 years of age with type 1 or 2 diabetes mellitus
  2. Patients with DME secondary to diabetes mellitus involving the center of the macula OCT thickness is > 300 microns with intraretinal cystic edema
  3. BCVA between 20/40 to 20/400
  4. Patient had vitrectomy surgery.
  5. Provide a signed informed consent prior to any study procedure

Exclusion Criteria:

  1. Patient unlikely to benefit from intravitreal Ozurdex due to macular ischemia, atrophy, or other condition
  2. Patient with history of steroid response with IOP >35 mm Hg or requirement to be on > 2 glaucoma medications following previous steroid injection.
  3. Previous injection of anti-VEGF or steroid in the study eye within 90 days
  4. Vitrectomy, cataract surgery, or YAG capsulotomy within 90 days.
  5. Current tractional detachment of the macula or vitreous hemorrhage obscuring details of the macula.
  6. Pregnant, lactating females, or females of child-bearing potential that are not using reliable contraception.

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dexamethasone implant up to every 3 Mo.

Ozurdex (dexamethasone) 0.7 mg implant will be performed on Day 0. All patients will be evaluated monthly thereafter.

Intervention: One month following initial implantation/sham, patients will be evaluated for focal or grid laser treatment if the investigator feels the patient will benefit.

Re-implantation of Ozurdex (dexamethasone) may occur at any time > 3 months following last injection in group 1 if any of the following conditions are met:

  1. Increase of > 50 microns from the best previous CRT measurement
  2. Recurrence of intraretinal cystic edema
  3. Persistent intraretinal cystic edema
Drug: Dexamethasone
Ozurdex (dexamethasone) 0.7mg steroid implant
Other Names:
  • Ozurdex
  • Dexamethasone Posterior segment drug delivery system
  • DEX PS DDS
Active Comparator: Dexamethasone implant up to every 6 Mo.

Ozurdex (dexamethasone) 0.7 mg implant will be performed on Day 0. All patients will be evaluated monthly thereafter.

Intervention: One month following initial implantation/sham, patients will be evaluated for focal or grid laser treatment if the investigator feels the patient will benefit.

Re-implantation of Ozurdex (dexamethasone) may occur at any time >6 months following last injection in group 2 if any of the following conditions are met:

  1. Increase of > 50 microns from the best previous CRT measurement
  2. Recurrence of intraretinal cystic edema
  3. Persistent intraretinal cystic edema
Drug: Dexamethasone
Ozurdex (dexamethasone) 0.7mg steroid implant
Other Names:
  • Ozurdex
  • Dexamethasone Posterior segment drug delivery system
  • DEX PS DDS
Sham Comparator: Sham Implant

Sham Procedure will be performed on Day 0. All patients will be evaluated monthly thereafter.

Intervention: One month following initial implantation/sham, patients will be evaluated for focal or grid laser treatment if the investigator feels the patient will benefit. Also, at 13 months, patients in the sham group will be eligible for Ozurdex (dexamethasone) 0.7 mg implantation if initial inclusion/exclusion criteria are met. These patients would follow re-implantation guidelines of group 2.

Sham implantation may occur at any time > 6 months following last sham injection in group 3 if any of the following conditions are met:

  1. Increase of > 50 microns from the best previous CRT measurement
  2. Recurrence of intraretinal cystic edema
  3. Persistent intraretinal cystic edema
Drug: Dexamethasone
Ozurdex (dexamethasone) 0.7mg steroid implant
Other Names:
  • Ozurdex
  • Dexamethasone Posterior segment drug delivery system
  • DEX PS DDS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Acuity Gain
Time Frame: 13 months
Measured visual acuity gain in number of letters improved as a result of treatment
13 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Central Retinal Thickness Reduction
Time Frame: 1 year
Central Retinal Thickness Reduction as measured by Heidelberg OCT
1 year
Comparison of Efficacy Between Group 1 and 2
Time Frame: 3 years
Comparison of efficacy between group 1 and group 2
3 years
Visual Acuity Gain at Year 2 and 3
Time Frame: 3 years
VA gain in ETDRS letters at years 2 and years 3
3 years
Time to Reimplantation of Ozurdex Implant
Time Frame: 3 years
Time in months until new implant is needed
3 years

Collaborators and Investigators

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

Sponsor

Lahey Clinic

Investigators

  • Principal Investigator: Fina C Barouch, MD, Lahey Clinic
  • Study Chair: Jeffrey L Marx, MD, Lahey Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

February 22, 2013

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 12, 2014

Study Registration Dates

First Submitted

February 7, 2013

First Submitted That Met QC Criteria

February 7, 2013

First Posted (Estimate)

February 11, 2013

Study Record Updates

Last Update Posted (Actual)

March 12, 2020

Last Update Submitted That Met QC Criteria

March 3, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-031

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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