Avastin in the treament of Macular oedema and Uveitis

• Conditions: 1. Macular oedema secondary to diabetic retinopathy; 2. Macular oedema secondary to uveitis; 3. Subfoveal choroidal neovascularisation (CNV) secondary to uveitis; Eye - Diseases / disorders of the eye; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12607000315415
• Lead Sponsor: Royal Victorian Eye and Ear Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-06-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Best corrected Early Treatment Diabetic Retinopathy Study (ETDRS) Visual acuity[At baseline and at 3 and 12 months after intervention commencement]

Secondary Outcome Measures

Name	Time	Method
Central Macular thickness as measured on Optical Coherence Tomography [At baseline and at 3 and 12 months after intervention commencement]