None listed
Conditions
Brief summary
Macular oedema, or swelling around the macula, results in decreased vision. It is termed "refractory" when it does not adequately respond to the usual treatment methods. It can occur with conditions like diabetic retinopathy or uveitis. Without effective treatment, vision loss can progress and become permanent. Early studies have suggested that a new treatment called Avastin (Bevacizumab) may be effective in treating this type of macular oedema, however further research is required to confirm this. Choroidal neovascularisation (CNV) is a condition where abnormal blood vessels grow in the back of the eye and causes blurred or distorted vision. Without treatment, vision loss may be quick and severe. There are many causes of CNV, the most common being Age Related Macular Degeneration. Uveitis can also cause this condition. As Avastin (Bevacizumab) has been found to be useful in the treatment of CNV due to AMD, it is expected that it will be useful in cases of CNV from uveitis. The purpose of this project is to assess whether Avastin (Bevacizumab) is both safe and effective in the treatment of the above conditions, namely: 1. Macular oedema due to diabetic retinopathy 2. Macular oedema due to uveitis 3. Choroidal neovascularisation due to uveitis
Interventions
Intravitreal injection of bevacizumab (1.25mg in 0.05ml) every six weeks as required. Visual acuity and central macular thickness will be compared against these measurements that were taken at baseline (ie. no controls).
Repeat injections will be performed in those with macular oedema if there is:
a) Persistence, relapse or increase of macular oedema involving the centre, or central macular thickness, demonstrated by examination and OCT
OR
b) A decline of best corrected visual acuity of 5 let
Intravitreal injection of bevacizumab (1.25mg in 0.05ml) every six weeks as required. Visual acuity and central macular thickness will be compared against these measurements that were taken at baseline (ie. no controls). Repeat injections will be performed in those with macular oedema if there is: a) Persistence, relapse or increase of macular oedema involving the centre, or central macular thickness, demonstrated by examination and OCT OR b) A decline of best corrected visual acuity of 5 letters (Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity) below the best visual acuity after treatment Repeat injections will be performed in those with uveitic CNV if there is: a) A decline of best corrected visual acuity of 5 letters (ETDRS LogMAR) below the best VA after treatment, OR b) An increase in OCT central retinal thickness of at least 100µm from the lowest thickness reading, OR c) New macular haemorrhage, OR d) New area of classic CNV, OR e) Evidence of persistent fluid on OCT at least one month after the previous injection Injections will be ceased if: 1. There is no improvement in either the visual acuity or central macular thickness after 3 injections in comparison to baseline measurements (i.e. Treatment failure), OR 2. Central macular thickness < 220 microns with no evidence of subretinal or intraretinal oedema as measured and assessed on Optical Coherence Tomography (OCT), OR 3. Best corected Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity is better than or equal to 6/6 The last 2 criteria listed above would be considered as a complete treatment response.
Sponsors
Royal Victorian Eye and Ear Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Clinically significant macular oedema secondary to diabetes involving the fovea in one or both eyes that has been refractory to previous standard treatments (e.g. laser) where local steroid therapy is contraindicated (e.g. pre-existing glaucoma or steroid responder) or ineffective, OR3. Uveitic cystoid macular oedema in one or both eyes that has either been unresponsive to standard treatment (including intravitreal triamcinolone) or where further local steroid treatment is relatively contraindicated (e.g. pre-existing glaucoma or steroid responder) or ineffective, OR4. Subfoveal or juxtafoveal choroidal neovascularisation (CNV) secondary to uveitis in one or both eyesBest corrected visual acuity in the affected eye(s) = 6/12 or worse5. Subjects must have signed the informed consent form.
Exclusion criteria
1. Loss of vision due to other causes (e.g. myopic macular degeneration)2. Surgical intervention in the study eye within 2 months preceding recruitment3. Significant macular ischaemia4. No useful vision in fellow eye5. Known allergies to bevacizumab or ranubizumab6. Active ocular infection (eg. Conjunctivitis, keratitis)7. Intercurrent severe disease such as septicaemia8. History of other systemic disease(s) that, in the opinion of the investigator, may render the subject at a high risk for treatment complications9. Any condition which would affect follow-up or photographic documentation (e.g. geographical, psycho-social, media opacities) 10. Unwillingness or inability to give informed consent11. Under age 1812. Pregnant or lactating women13. Premenopausal women of child bearing potential not using adequate contraception. Adequate contraception includes the use of one or more of the following: surgical sterilisation (tubal ligation), hormonal sterilisation (implant, patch or oral), and double barrier methods (any double combination of: IUD, condom with spermicidal gel, diaphragm, sponge, cervical cap). Reliable contraception must be maintained throughout the study and for 30 days after bevacizumab discontinuation. 14. Uncontrolled, active intraocular inflammation, defined as being greater than or equal to 2+ anterior chamber cell and/or greater than trace vitreal haze and/or signs of active chorioretinitis as per the SUN criteria
Outcome results
None listed