The Efficacy and Safety of Treatment with Intravitreal Ranibizumab in Patients with Branch Retinal Vein Occlusion.
Associate Professor Ian McAllister
40 participants
Jul 26, 2007
Interventional
Conditions
Summary
This is a phase II randomised, single, dose, masked, multicentre trial to determine the efficacy of 0.5mg Ranibizumab intravitreal injections in the treatment of macular oedema secondary to BRVO over one year compared with standard laser grid. Patients eligible for the study will be randomised to receive an intravitreal injection of 0.5mg Ranibizumab or placebo for 6 months. Patients will be monitored for a further 6 months to see whether further treatment is required. Patients are evaluated by a masked investigator at 3 and 6 months to determine whether they require laser grid, the current standard treatment for this condition. The primary outcome will be the proportion of eyes showing an improvement of visual acuity by 10 letters on the LogMar chart for the treatment group versus the sham group at 52 weeks compared with baseline. The secondary outcome will be the change in baseline OCT central macular thickness between the treatment and the sham groups at 52 weeks. The tertiary objective will be the change in the mean capillary non-perfusion between the sham/laser and treatment groups at 52 weeks and the number of patients requiring grid macular laser.
Eligibility
Inclusion Criteria1
- Macular oedema in the study eye with the following characteristics:a. Due to BRVO.b. Involving the centre of the fovea.c. Duration 6 week to 9 months prior to baseline visit.d. Visual acuity reduction attributable to the oedema where the macula is non-ischaemic (<50% ischaemic injury to the perifoveolae vascular zone).2. Best corrected visual acuity (BCVA) score as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) chart at baseline between 20 letters and 68 letters (approximately 20/50 to 20/400 Snellen visual acuity). 3. Central macular oedema as measured by OCT at baseline to exceed 250 um. 4. Clear ocular media and adequate pupillary dilation.5. Written informed consent.6. Ability to return for all study visits.
Exclusion Criteria1
- Women of childbearing potential not using the contraception method(s) specified in this study (specify), as well as women who are breastfeeding.2. Known sensitivity to study drug(s) or class of study drug(s).3. Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required). 4. Use of any other investigational agent in the last 30 days.5. Any other ocular condition in the study eye that would prevent improvement in visual acuity, e.g., macular ischaemia, underlying macular degeneration, epi-retinal membrane.6. Neovascularisation of the iris, disc or retina.7. Previous treatment with intravitreal corticosteriods, intravitreal anti-VEGF agents or macular grid laser in previous 3 months.8. Aphakia or presence of anterior chamber lens in the study eye.9. Significant media opacities such as cataract.10. Previous pars plana vitrectomy.11. History of retinal detachment or surgery for retinal detachment.12. Any condition which would preclude a patient's ability to comply with the study requirements or to be available for the duration of the study.13. BRVOs that have more than 10-disc diamteres of capillary non perfusion.14. Any active infection involving ocular adnexa including infectious conjunctivitis, keratitis, sclertitis, endoophthalmitis as well as idiopathic or autoimmune-associated uveitis in either eye.15. Presence of a retinal pigment epithelial tear involving the macula in the study eye.16. Any evidence of significant AMD in the study eye.17. Extra capsular extraction of cataract with phacoemulsification within 3 months preceding baseline, or a history of post-operative complications within the last 12 months preceding baseline in the study eye (uveitis, cyclitis etc).18. Contra indication to pupil dilation in either eye.
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Interventions
Patients who have macula oedema secondary to Branch Retinal Vein Occlusion (BRVO), patients who meet all the eligibilty criteria and who sign a Patient Information and Consent Form, will be randomsied to receive 0.5mg Ranibizumab (Lucentis) or placebo as an intravitreal injection into the study eye monthly for 6 months. After 6 months, patients will be evaluated and may receive further intravitreal injections, if they are required (up to 6 injections). All patients will be evaluated by a masked investigator at 3 and 6 months for laser grid treatment, this is the standard treatment for this condition.
Locations(1)
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ACTRN12607000262404