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

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sydney
• Collaborator: National Health and Medical Research Council, Australia
• Treatments: BB 1101; Bevacizumab; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

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