None listed
Conditions
Brief summary
The primary objective of this randomised controlled trial is to evaluate the efficacy of intravitreal Bevacizumab in the treatment of macular oedema following branch retinal vein occlusion (BRVO) and compare it with present day standard treatment, macular laser.
Interventions
Bevacizumab is a recombinant humanised monoclonal antibody to vascular epithelial growth factor (VEGF) designed for IV administration and approved for treatment of colorectal cancer.
It has recently emerged as a novel therapeutic strategy for retinal diseases, especially age-related macular degeneration, and, in retrospective short-term studies, has also proven to be effective in central retinal and branch retinal vein occlusion. None of the clinical and experimental studies published so far ha
Bevacizumab is a recombinant humanised monoclonal antibody to vascular epithelial growth factor (VEGF) designed for IV administration and approved for treatment of colorectal cancer. It has recently emerged as a novel therapeutic strategy for retinal diseases, especially age-related macular degeneration, and, in retrospective short-term studies, has also proven to be effective in central retinal and branch retinal vein occlusion. None of the clinical and experimental studies published so far have found any drug-related toxic effects on any retinal structures. Patients will receive a minimum of 3 doses of Bevacizumab 1.25 mg via intravitreal injection to the eye at monthly intervals, then as required for up to 12 months.The procedure on each occasion will take 5 minutes.
Sponsors
Royal Adelaide Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
> 18 years of age Males and females Duration of BRVO > 3 months Best Correct Visual Acuity (BCVA) < 20/40 CRT > 250 micro m in the central subfield or >300microns in the inner subfield. Adequate renal function (glomerular filtration calculated by Cockcroft/Gault formula or measure urine creatinine clearance > or = to 50 mL/minute)
Exclusion criteria
History of submacular surgery or other surgical intervention for Aged Macular Degeneration (AMD) in the study eye, glaucoma filtration surgery, corneal transplant surgery or diabetic maculopathy. Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within one month preceding baseline, Extracapsular extraction of cataract with phacoemulsification within three months preceding Baseline, or a history of post-operative complications within the last 12 months preceding Baseline in the study eye (uveitis, cyclitis, etc.), History of uncontrolled glaucoma in the study eye (defined as intraocular pressure is greater than or equal to 25 mmHg despite treatment with anti-glaucoma medication), Aphakia with absence of the posterior capsule in the study eye, Active intraocular inflammation (grade trace or above) in the study eye, Any active infection involving ocular adnexa including infectious conjunctivitis, keratitis, scleritis, endophthalmitis, as well as idiopathic or autoimmune-associated uveitis in either eye, Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye, Presence of a retinal pigment epithelial tear involving the macula in the study eye, Subfoveal fibrosis or significant atrophy in the study eye Women of childbearing potential not using the contraception method(s) specified in this study (specify), as well as women who are breastfeeding Known sensitivity to study drug(s) or class of study drug(s) Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required) Use of any other investigational agent in the last 30 days
Outcome results
None listed