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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Sydney
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
University of Sydney
ClinicalTrials.gov Identifier:
NCT01787669
First received: February 6, 2013
Last updated: June 11, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Diabetes
Diabetic Macular Oedema
Diabetic Macular Edema
Diabetic Retinopathy
Drug: Avastin (Bevacizumab)
Drug: Ozurdex (dexamethasone)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicentre Clinical Trial of Switching Between Intravitreal Bevacizumab (Avastin®) and Intravitreal Dexamethasone (Ozurdex™) for Persistent Diabetic Macular Oedema (SwitchDMO)

Resource links provided by NLM:


Further study details as provided by University of Sydney:

Primary Outcome Measures:
  • Proportion of eyes that have central macular thickness <300 microns 6 months after switching [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change in central macular thickness (CMT) as measured by OCT. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Mean change in central macular thickness (CMT) as measured by OCT.


Other Outcome Measures:
  • Mean change in BCVA (best corrected visual acuity) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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


Estimated Enrollment: 50
Study Start Date: June 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Avastin (Bevacizumab)
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
Other Name: Ozurdex (dexamethasone)

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01787669

Contacts
Contact: Samantha FRASER-BELL +61-2-93827309
Contact: Maria Williams +61-2-93827309

Locations
Australia, New South Wales
Sydney Eye Hospital Recruiting
Sydney, New South Wales, Australia, 2000
Contact: Kate Llewelyn    02 9382 7309      
Principal Investigator: SAMANTHA FRASER-BELL         
Australia, Victoria
Centre for Eye Research Australia (Royal Victorian Eye & Ear Hospital) Recruiting
Melbourne, Victoria, Australia, 3002
Contact: Sutha Sanmugasundram         
Principal Investigator: Lyndell Lim         
Australia, Western Australia
Lions Eye Institute Recruiting
Perth, Western Australia, Australia, 6009
Contact: Sharon Radke         
Principal Investigator: Ian McAllister         
Sponsors and Collaborators
University of Sydney
Allergan
Investigators
Principal Investigator: Samantha FRASER-BELL SAVE SIGHT INSTITUTE, UNIVERSITY OF SYDNEY, SYDNEY EYE HOSPITAL
  More Information

No publications provided

Responsible Party: University of Sydney
ClinicalTrials.gov Identifier: NCT01787669     History of Changes
Other Study ID Numbers: SwitchDMO
Study First Received: February 6, 2013
Last Updated: June 11, 2014
Health Authority: Australia: Human Research Ethics Committee
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by University of Sydney:
diabetic macular oedema
diabetic macular edema
diabetic retinopathy
dexamethasone
Ozurdex
Avastin
bevacizumab
DME
DMO

Additional relevant MeSH terms:
Edema
Macular Edema
Diabetic Retinopathy
Retinal Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Endocrine System Diseases
Eye Diseases
Macular Degeneration
Retinal Degeneration
Signs and Symptoms
Vascular Diseases
BB 1101
Bevacizumab
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids

ClinicalTrials.gov processed this record on October 21, 2014