NCT01298076

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2010

Typical duration for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 17, 2011

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

June 3, 2015

Status Verified

June 1, 2015

Enrollment Period

3.9 years

First QC Date

August 31, 2010

Last Update Submit

June 2, 2015

Conditions

Diabetic RetinopathyMacular Edema

Keywords

DiabetesRetinopathyMacular oedemaLaserPhotocoagulationFoveaSteroidBevacizumabIntravitreal

Outcome Measures

Primary Outcomes (1)

  • Visual acuity gain

    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.

    2 years

Secondary Outcomes (5)

  • Visual acuity change

    2 years

  • OCT change

    2 years

  • Laser requirement

    2 years

  • Patient satisfaction

    2 years

  • Safety

    2 years

Study Arms (2)

AVASTIN

ACTIVE COMPARATOR

intravitreal bevacizumab

Drug: bevacizumab

OZURDEX

ACTIVE COMPARATOR

intravitreal dexamethasone

Drug: dexamethasone

Interventions

bevacizumabDRUG

Anti-VEGF drug for intravitreal injection

AVASTIN
dexamethasoneDRUG

Slow-release steroid formulation for intravitreal injection

OZURDEX

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Save Sight Institute

Sydney, New South Wales, 2001, Australia

Location

South West Retina

Sydney, New South Wales, 2170, Australia

Location

Centre for Eye Research Australia

Melbourne, Victoria, 3002, Australia

Location

Lions Eye Institute

Perth, Western Australia, 6009, Australia

Location

Related Publications (7)

  • Rittiphairoj T, Mir TA, Li T, Virgili G. Intravitreal steroids for macular edema in diabetes. Cochrane Database Syst Rev. 2020 Nov 17;11(11):CD005656. doi: 10.1002/14651858.CD005656.pub3.

    PMID: 33206392DERIVED

  • Mehta H, Fraser-Bell S, Nguyen V, Lim LL, Gillies MC. The Interval between Treatments of Bevacizumab and Dexamethasone Implants for Diabetic Macular Edema Increased over Time in the BEVORDEX Trial. Ophthalmol Retina. 2018 Mar;2(3):231-234. doi: 10.1016/j.oret.2017.06.010. Epub 2017 Aug 23.

    PMID: 31047591DERIVED

  • Mehta H, Fraser-Bell S, Nguyen V, Lim LL, Gillies MC. Short-term vision gains at 12 weeks correlate with long-term vision gains at 2 years: results from the BEVORDEX randomised clinical trial of bevacizumab versus dexamethasone implants for diabetic macular oedema. Br J Ophthalmol. 2018 Apr;102(4):479-482. doi: 10.1136/bjophthalmol-2017-310737. Epub 2017 Aug 4.

    PMID: 28779007DERIVED

  • Wickremasinghe SS, Fraser-Bell S, Alessandrello E, Mehta H, Gillies MC, Lim LL. Retinal vascular calibre changes after intravitreal bevacizumab or dexamethasone implant treatment for diabetic macular oedema. Br J Ophthalmol. 2017 Oct;101(10):1329-1333. doi: 10.1136/bjophthalmol-2016-309882. Epub 2017 Feb 22.

    PMID: 28228411DERIVED

  • Aroney C, Fraser-Bell S, Lamoureux EL, Gillies MC, Lim LL, Fenwick EK. Vision-Related Quality of Life Outcomes in the BEVORDEX Study: A Clinical Trial Comparing Ozurdex Sustained Release Dexamethasone Intravitreal Implant and Bevacizumab Treatment for Diabetic Macular Edema. Invest Ophthalmol Vis Sci. 2016 Oct 1;57(13):5541-5546. doi: 10.1167/iovs.16-19729.

    PMID: 27768792DERIVED

  • Mehta H, Fraser-Bell S, Yeung A, Campain A, Lim LL, Quin GJ, McAllister IL, Keane PA, Gillies MC. Efficacy of dexamethasone versus bevacizumab on regression of hard exudates in diabetic maculopathy: data from the BEVORDEX randomised clinical trial. Br J Ophthalmol. 2016 Jul;100(7):1000-1004. doi: 10.1136/bjophthalmol-2015-307797. Epub 2015 Nov 4.

    PMID: 26537156DERIVED

  • Gillies MC, Lim LL, Campain A, Quin GJ, Salem W, Li J, Goodwin S, Aroney C, McAllister IL, Fraser-Bell S. A randomized clinical trial of intravitreal bevacizumab versus intravitreal dexamethasone for diabetic macular edema: the BEVORDEX study. Ophthalmology. 2014 Dec;121(12):2473-81. doi: 10.1016/j.ophtha.2014.07.002. Epub 2014 Aug 22.

    PMID: 25155371DERIVED

MeSH Terms

Conditions

Diabetic RetinopathyMacular EdemaDiabetes MellitusRetinal Diseases

Interventions

BevacizumabDexamethasone

Condition Hierarchy (Ancestors)

Eye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsEndocrine System DiseasesMacular DegenerationRetinal DegenerationGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Mark C Gillies, Professor

    University of Sydney

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 31, 2010

First Posted

February 17, 2011

Study Start

October 1, 2010

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

June 3, 2015

Record last verified: 2015-06

Locations

AU(4)