Trial of Switching Between Intravitreal Bevacizumab (Avastin®)& Intravitreal Dexamethasone (Ozurdex™) for Persistent Diabetic Macular Oedema (SwitchDMO)

November 9, 2018 updated by: University of Sydney

A Multicentre Clinical Trial of Switching Between Intravitreal Bevacizumab (Avastin®) and Intravitreal Dexamethasone (Ozurdex™) for Persistent Diabetic Macular Oedema (SwitchDMO)

The specific aim of the study is to test the following hypothesis:

That switching between treatments from bevacizumab to Ozurdex or vice versa in eyes with diabetic macular oedema with no or incomplete response from one therapy is beneficial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A Multicentre Clinical Trial of Switching Between Intravitreal Bevacizumab (Avastin®) and Intravitreal Dexamethasone (Ozurdex™) for Persistent Diabetic Macular Oedema (SwitchDMO)

Study Type

Interventional

Enrollment (Actual)

19

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

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2000
        • Sydney Eye Hospital
    • Victoria
      • Melbourne, Victoria, Australia, 3002
        • Centre for Eye Research Australia (Royal Victorian Eye & Ear Hospital)
    • Western Australia
      • Perth, Western Australia, Australia, 6009
        • Lions Eye 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:

Eyes Previously Treated with bevacizumab:

  1. Diabetic macular oedema affecting the fovea that has persisted despite ongoing, monthly intravitreal injections of bevacizumab over at least 6 months, the last being 2 to 3 months prior to the screening visit.
  2. There must be an historical OCT available from 1-4 weeks after the last bevacizumab injection with retinal thickness > 300 microns in the central 1mm subfield on Spectral domain OCT to show the lack of complete response to bevacizumab.

  3. At screening, the bevacizumab treated eye must have DMO with retinal thickness > 300 microns in the central 1mm subfield on Spectral domain OCT

    Eyes Previously Treated with dexamethasone:

  4. Diabetic macular oedema affecting the fovea that has persisted despite two dexamethasone implants 5 or fewer months apart, the last being 5-8 months prior to the screening visit.
  5. There must be an historical OCT available from 8-14 weeks after the last dexamethasone implant with retinal thickness > 300 microns in the central 1mm subfield on Spectral domain OCT to show the lack of complete response to the dexamethasone implant.
  6. At screening, the dexamethasone treated eye must have DMO with retinal thickness > 300 microns in central 1mm subfield on Spectral domain OCT
  7. Age >= 18 years
  8. Diagnosis of diabetes mellitus
  9. Best corrected visual acuity of 20-78 letters (approx 6/120 -6/7.5)
  10. Previous macular laser treatment, or the investigator believes laser treatment is unlikely to be helpful
  11. Intraocular pressure <22mmHg
  12. Women of childbearing potential must have a negative urine pregnancy test at the screening visit and prior to treatment. A woman is considered of childbearing potential unless she is postmenopausal and without menses for 12 months or is surgically sterilised
  13. Written informed consent has been obtained.

Exclusion Criteria:

  • Treatment with intravitreal triamcinolone acetonide (IVTA) within the last 6 months or peribulbar TA within the last 3 months, or anti vascular endothelial growth factor (VEGF) drugs: ranibizumab and aflibercept, within the last 2 months.
  • Cataract surgery within the last 3 months
  • Retinal laser treatment within the last 3 months
  • For eyes to be switched to Dexamethasone: Patient considered, at the judgement of the investigator, to be at-risk for syphilis, tuberculosis or other potentially infective chorioretinopathies. Patients considered at-risk may be assessed at the investigators discretion to reasonably exclude these conditions. Should these conditions be excluded, the patient may be considered for enrolment.

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: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Avastin (bevacizumab)
Intravitreal Avastin loading doses followed by as prn for remainder of 6 months according to defined retreatment criteria
Drug: Avastin (Bevacizumab)
Avastin (Bevacizumab) administered intravitreally
ACTIVE_COMPARATOR: Ozurdex (dexamethasone)
single dose at baseline and repeat dose when required according to defined re-treatment criteria
Drug: Ozurdex (dexamethasone)
Ozurdex (dexamethasone) given intravitreally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of eyes that have central macular thickness <300 microns 6 months after switching
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change in central macular thickness (CMT) as measured by OCT.
Time Frame: 6 months
Mean change in central macular thickness (CMT) as measured by OCT.
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change in BCVA (best corrected visual acuity)
Time Frame: 6 months

Proportion of eyes with a gain of 15 LogMAR letters or more

  • Proportion of eyes with a loss of less than 15 LogMAR letters
  • Proportion of eyes with gain of 5 LogMAR letters or more
  • Proportion of eyes with gain of 10 LogMAR letters or more
6 months

Collaborators and Investigators

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

Sponsor

University of Sydney

Collaborators

Allergan

Investigators

  • Principal Investigator: Samantha FRASER-BELL, SAVE SIGHT INSTITUTE, UNIVERSITY OF SYDNEY, SYDNEY EYE HOSPITAL

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

June 1, 2013

Primary Completion (ACTUAL)

January 1, 2017

Study Completion (ACTUAL)

October 1, 2017

Study Registration Dates

First Submitted

February 6, 2013

First Submitted That Met QC Criteria

February 6, 2013

First Posted (ESTIMATE)

February 8, 2013

Study Record Updates

Last Update Posted (ACTUAL)

November 13, 2018

Last Update Submitted That Met QC Criteria

November 9, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SwitchDMO

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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