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

Phase 2

Completed

• Conditions: Diabetes; Diabetic Macular Oedema; Diabetic Macular Edema; Diabetic Retinopathy
• Interventions: Drug: Ozurdex (dexamethasone); Drug: Avastin (Bevacizumab)

• Registration Number: NCT01787669
• Lead Sponsor: University of Sydney

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2013-02-06
• Study First Submitted QC: 2013-02-06
• Study First Posted: 2013-02-08
• Study Start: 2013-06
• Primary Completion: 2017-01
• Study Completion: 2017-10
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-09
• Last Update Posted: 2018-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ozurdex (dexamethasone)	Ozurdex (dexamethasone)	single dose at baseline and repeat dose when required according to defined re-treatment criteria
Avastin (bevacizumab)	Avastin (Bevacizumab)	Intravitreal Avastin loading doses followed by as prn for remainder of 6 months according to defined retreatment criteria

Primary Outcome Measures

Name	Time	Method
Proportion of eyes that have central macular thickness <300 microns 6 months after switching	6 months

Secondary Outcome Measures

Name	Time	Method
Mean change in central macular thickness (CMT) as measured by OCT.	6 months	Mean change in central macular thickness (CMT) as measured by OCT.

Trial Locations

Locations (3)

Centre for Eye Research Australia (Royal Victorian Eye & Ear Hospital); 🇦🇺 Melbourne, Victoria, Australia

Lions Eye Institute; 🇦🇺 Perth, Western Australia, Australia

Sydney Eye Hospital; 🇦🇺 Sydney, New South Wales, Australia