Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema

March 8, 2021 updated by: Ron P. Gallemore, Retina Macula Institute

Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema.

The purpose of this study is to test the efficacy of an 0.7 mg intravitreal dexamethasone implant (Ozurdex®) on macular leakage and visual acuity for patients with recalcitrant diabetic macular edema.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an open-label, Phase II comparative study of an intravitreal dexamethasone implant versus intravitreal bevacizumab (Avastin) in 20 patients with recalcitrant diabetic macular edema and prior treatment with ≥ 2 intravitreal anti-VEGF injections.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

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
    • California
      • Torrance, California, United States, 90503
        • Retina Macula Institute

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:

  • Presence of NPDR or PDR as confirmed by fluorescein angiography
  • Prior treatment with >= 2 intravitreal anti-VEGF injections but no treatment in last 4 weeks
  • < 0.1 LogOCT decrease in macular edema on high resolution OCT between initial visit and following treatment with >= 2 intravitreal anti-VEGF injections
  • Age 18 years or older
  • ETDRS Visual acuity between 3 and 78 letters (approximate Snellen equivalent of 20/25 to 20/800)
  • Ability to provide written informed consent
  • Capable of complying with study protocol.

Exclusion Criteria:

  • Intraocular injection of steroid medication within prior 3 months
  • Evidence of significant geographic atrophy on fluorescein angiography in the opinion of the treating physician
  • Concurrent ocular disease (wet AMD, significant ERM, etc) that would limit visual acuity in the opinion of the treating physician
  • Prior vitrectomy surgery
  • Use of systemic steroids (eg, oral, intravenous, intramuscular, epidural, rectal, or extensive dermal) within 1 month prior to day 1.
  • Known history of IOP elevation in response to steroid treatment in either eye that resulted in any of the following: a) = 10 mm Hg increase in IOP in response to steroid injection, or b) IOP = 25 mm Hg and required 2 or more anti-glaucoma medications to keep IOP below 21 mm Hg.
  • Patients who are pregnant.
  • Unwilling or unable to follow or comply with all study related procedures

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ozurdex
Patients in this group receive Ozurdex at initial visit and at month 4
Drug: dexamethasone intravitreal implant
Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)
Other Names:
  • Ozurdex
Active Comparator: Avastin
Patients in this group receive Avastin Q1 month for 5 months.
Drug: intravitreal bevacizumab
Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.
Other Names:
  • Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Change in Visual Acuity (Number of ETDRS Letters).
Time Frame: 6 months
The measure the change in ETDRS letters for each treatment group from baseline to 6 months.
6 months
The Change in Central Foveal Thickness (Microns on High Resolution OCT).
Time Frame: 6 months
The measure the change in central foveal thickness for each treatment group from baseline to 6 months.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Change in Macular Leakage on Fluorescein Angiography From Baseline
Time Frame: 6 months
To qualitatively assess the change in macular leakage on fluorescein angiography from baseline to 6 months for each treatment arm.
6 months
The Change in Mean Macular Sensitivity on Microperimetry From Baseline
Time Frame: 6 months
To assess the change in macular sensitivity on microperimetry from baseline to 6 months for each treatment arm.
6 months
The Change in Mean Central Amplitude on Multi-focal ERG From Baseline.
Time Frame: 6 months
To assess the change in mean central amplitude on multi-focal ERG from baseline to 6 months for each treatment arm.
6 months

Collaborators and Investigators

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

Sponsor

Retina Macula Institute

Collaborators

Allergan

Investigators

  • Principal Investigator: Ron P Gallemore, M.D, Ph.D, Retina Macula Institute

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

April 1, 2012

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

April 2, 2012

First Submitted That Met QC Criteria

April 4, 2012

First Posted (Estimate)

April 5, 2012

Study Record Updates

Last Update Posted (Actual)

March 30, 2021

Last Update Submitted That Met QC Criteria

March 8, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT-406

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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