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

Sponsor
University of Sydney
Study ID
NCT01787669
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Avastin (Bevacizumab) — DRUG
    Avastin (Bevacizumab) administered intravitreally
  • Ozurdex (dexamethasone) — DRUG
    Ozurdex (dexamethasone) given intravitreally

Study Details

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.

Key Dates

First listed
Feb 8, 2013
Start date
Jun 30, 2013
Status verified
Nov 2018
Primary completion
Jan 31, 2017
Completion
Oct 31, 2017

Study Design

Enrollment
19 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

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

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