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Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema

Primary Purpose

Diabetic Macular Edema, Non-proliferative Diabetic Retinopathy, Proliferative Diabetic Retinopathy

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
dexamethasone intravitreal implant
intravitreal bevacizumab
Sponsored by
Retina Macula Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring Macular Edema, DME, PDR, NPDR, Ozurdex, Dexamethasone, Avastin, Bevacizumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Retina Macula Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ozurdex

Avastin

Arm Description

Patients in this group receive Ozurdex at initial visit and at month 4

Patients in this group receive Avastin Q1 month for 5 months.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 2, 2012
Last Updated
March 8, 2021
Sponsor
Retina Macula Institute
Collaborators
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT01571232
Brief Title
Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema
Official Title
Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Retina Macula Institute
Collaborators
Allergan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema, Non-proliferative Diabetic Retinopathy, Proliferative Diabetic Retinopathy
Keywords
Macular Edema, DME, PDR, NPDR, Ozurdex, Dexamethasone, Avastin, Bevacizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ozurdex
Arm Type
Active Comparator
Arm Description
Patients in this group receive Ozurdex at initial visit and at month 4
Arm Title
Avastin
Arm Type
Active Comparator
Arm Description
Patients in this group receive Avastin Q1 month for 5 months.
Intervention Type
Drug
Intervention Name(s)
dexamethasone intravitreal implant
Other Intervention Name(s)
Ozurdex
Intervention Description
Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)
Intervention Type
Drug
Intervention Name(s)
intravitreal bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.
Primary Outcome Measure Information:
Title
The Change in Visual Acuity (Number of ETDRS Letters).
Description
The measure the change in ETDRS letters for each treatment group from baseline to 6 months.
Time Frame
6 months
Title
The Change in Central Foveal Thickness (Microns on High Resolution OCT).
Description
The measure the change in central foveal thickness for each treatment group from baseline to 6 months.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The Change in Macular Leakage on Fluorescein Angiography From Baseline
Description
To qualitatively assess the change in macular leakage on fluorescein angiography from baseline to 6 months for each treatment arm.
Time Frame
6 months
Title
The Change in Mean Macular Sensitivity on Microperimetry From Baseline
Description
To assess the change in macular sensitivity on microperimetry from baseline to 6 months for each treatment arm.
Time Frame
6 months
Title
The Change in Mean Central Amplitude on Multi-focal ERG From Baseline.
Description
To assess the change in mean central amplitude on multi-focal ERG from baseline to 6 months for each treatment arm.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ron P Gallemore, M.D, Ph.D
Organizational Affiliation
Retina Macula Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Retina Macula Institute
City
Torrance
State/Province
California
ZIP/Postal Code
90503
Country
United States

12. IPD Sharing Statement

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Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema

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