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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01298076
Recruitment Status : Completed
First Posted : February 17, 2011
Last Update Posted : June 3, 2015
National Health and Medical Research Council, Australia
Information provided by (Responsible Party):
Mark Gillies, University of Sydney

Brief Summary:

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

Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Macular Edema Drug: bevacizumab Drug: dexamethasone Phase 2

Detailed Description:

Diabetic retinopathy is a common cause of severe loss of vision and the most common cause of blindness in individuals between the ages of 20 and 65 years in developed countries. Swelling of the central retina, or "macular oedema", is the commonest cause of visual loss in diabetic retinopathy.

Diabetic macular oedema (DMO) is treated with laser photocoagulation of areas of leak in the macula according to established guidelines which take into account the extent of the leak and its proximity to the centre of the macula, the "fovea". This treatment does not always work, however, and is inherently destructive.

New drugs have become available which appear to reduce the risk of loss of vision in eyes with advanced diabetic macular oedema for which further laser treatment is unlikely to be beneficial. Intravitreal injection of slow-release steroid formulations such as Ozurdex™, a slow release formulation of dexamethasone, has been proposed as a new modality to treat clinically significant DMO. We have recently conducted randomised clinical trials which have demonstrated that treatment with intravitreal triamcinolone (IVTA) leads to reduction of DMO and improved vision in these eyes. Another class of drugs, inhibitors of Vascular Endothelial Growth Factor (VEGF) such as bevacizumab (Avastin®), also appear efficacious.

While both drugs appear to reduce macular oedema and improve vision in the short term, they may have differences which could guide how they are best used. Around 1/3 of eyes that receive dexamethasone may develop elevated intraocular pressure and cataract, both of which are manageable but may complicate the picture. Anti-VEGF drugs do not have these local adverse events, however they must be given more frequently (4-6 weekly vs 4-6 monthly for Ozurdex™) and it is suspected they may have a neurotoxic effect on the retina. Some authorities suspect that anti-VEGF treatment may be associated with a small increased risk of having a stroke or heart attack during treatment, even when they are injected into the eye. This has not been proven with a related drug, ranibizumab, but it is still possible that it may occur with bevacizumab.

This will be a, 2 year, phase II, prospective, multicentre, randomised, single-masked clinical trial of sustained release intravitreal dexamethasone (Ozurdex™) versus intravitreal injections of bevacizumab (Avastin®) for diabetic foveal oedema that persists or recurs despite previous laser treatment, or for which the investigator believes laser treatment is unlikely to be helpful.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicentre Randomised Clinical Trial of Intravitreal Bevacizumab (Avastin®) Versus Intravitreal Dexamethasone (Ozurdex™) for Persistent Diabetic Macular Oedema
Study Start Date : October 2010
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Active Comparator: AVASTIN
intravitreal bevacizumab
Drug: bevacizumab
Anti-VEGF drug for intravitreal injection

Active Comparator: OZURDEX
intravitreal dexamethasone
Drug: dexamethasone
Slow-release steroid formulation for intravitreal injection

Primary Outcome Measures :
  1. Visual acuity gain [ Time Frame: 2 years ]
    The comparison of the proportion of eyes gaining 10 letters of visual acuity between the bevacizumab (Avastin®) and dexamethasone (Ozurdex™) implant arms after 104 weeks.

Secondary Outcome Measures :
  1. Visual acuity change [ Time Frame: 2 years ]
    Change in visual acuity compared with the pre-injection level

  2. OCT change [ Time Frame: 2 years ]
    Change in retinal thickness demonstrated on optical coherence tomography(OCT)

  3. Laser requirement [ Time Frame: 2 years ]
    Number of laser treatments required for the treatment of macular oedema

  4. Patient satisfaction [ Time Frame: 2 years ]
    Patient satisfaction with treatment

  5. Safety [ Time Frame: 2 years ]
    • Mean change in maximum diameter of foveal avascular zone
    • Incidence and severity of ocular adverse events
    • Incidence and severity of non ocular adverse events

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age >= 18 years
  • Diagnosis of diabetes mellitus types 1 or 2
  • Diabetic macular oedema affecting the fovea in one or both eyes (phakic or pseudophakic) for which laser treatment is unlikely to be helpful in the opinion of the centre chief investigator
  • Best corrected visual acuity of 17-72 letters (6/12 -6/120)
  • Retinal thickness > 250 micron in central 1mm subfield on Stratus (time domain) OCT and 300 on Spectral domain OCT
  • Previous macular laser treatment, or the investigator believes laser treatment is unlikely to be helpful
  • Intraocular pressure <22mmHg
  • 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
  • Written informed consent has been obtained.

Exclusion Criteria:

  • Known allergy to Ozurdex, Avastin or agents used in the study
  • Women who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using reliable means of contraception
  • Glaucoma which is uncontrolled or is controlled but with more than one medication or with only one medication and with glaucomatous field defects
  • Loss of vision due to other causes (e.g. age related macular degeneration, myopic macular degeneration, retinal vein occlusion)
  • Macular oedema due to other causes
  • An ocular condition that would prevent visual acuity improvement despite resolution of oedema (such as foveal atrophy or substantial premacular fibrosis)
  • Treatment with IVTA within the last 6 months or peribulbar TA within the last 3 months or bevacizumab within the last 2 months.
  • Cataract surgery within the last 6 months
  • Retinal laser treatment within the last 3 months
  • History of herpes virus infection in study eye
  • Media opacity including cataract that already precludes adequate macular photography and laser treatment, or cataract that is likely to require surgery within 2 years
  • Known allergies to dexamethasone or bevacizumab
  • Patient is already receiving systemic steroid treatment > 5mg prednisolone daily or equivalent)
  • Intercurrent severe disease such as septicemia, any condition which would affect follow-up or photographic documentation (e.g. geographical, psycho-social)
  • History of chronic renal failure requiring dialysis or renal transplant
  • Blood pressure >180/110
  • Patient has a condition or is in a situation that in the investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01298076

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Australia, New South Wales
Save Sight Institute
Sydney, New South Wales, Australia, 2001
South West Retina
Sydney, New South Wales, Australia, 2170
Australia, Victoria
Centre for Eye Research Australia
Melbourne, Victoria, Australia, 3002
Australia, Western Australia
Lions Eye Institute
Perth, Western Australia, Australia, 6009
Sponsors and Collaborators
University of Sydney
National Health and Medical Research Council, Australia
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Principal Investigator: Mark C Gillies, Professor University of Sydney
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Mark Gillies, Professor, University of Sydney Identifier: NCT01298076    
Other Study ID Numbers: NHMRC project 632667
2009-01024 ( Other Grant/Funding Number: NHMRC-PROJECT GRANT ACCEPTANCE-RIMS Project ID )
First Posted: February 17, 2011    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: June 2015
Keywords provided by Mark Gillies, University of Sydney:
Macular oedema
Additional relevant MeSH terms:
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Macular Edema
Retinal Diseases
Diabetic Retinopathy
Macular Degeneration
Retinal Degeneration
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists