Intravitreal Bevacizumab (Avastin®) Versus Intravitreal Dexamethasone (Ozurdex™) for Persistent Diabetic Macular Oedema

Sponsor
University of Sydney
Study ID
NCT01298076
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • bevacizumab — DRUG
    Anti-VEGF drug for intravitreal injection
  • dexamethasone — DRUG
    Slow-release steroid formulation for intravitreal injection

Study Details

The specific aims of the study are to test the following hypotheses: * That there is a difference in change in visual acuity resulting from treatment with intravitreal bevacizumab compared with dexamethasone implant in eyes with advanced macular oedema * That there is a difference in degree of resolution of macular oedema resulting from treatment with intravitreal bevacizumab compared with dexamethasone implant in eyes with advanced macular oedema * That both intravitreal bevacizumab and dexamethasone implants have a manageable and acceptable safety profile in eyes with diabetic macular oedema

Key Dates

First listed
Feb 17, 2011
Start date
Oct 31, 2010
Status verified
Jun 2015
Primary completion
Sep 30, 2014
Completion
Sep 30, 2014

Study Design

Enrollment
61 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: AVASTIN
    intravitreal bevacizumab
  • Active Comparator: OZURDEX
    intravitreal dexamethasone

Primary Outcome Measure

Visual acuity gain [ Time Frame: 2 years ]

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