The combination treatment of laser bypass (chorioretinal venous anastomosis) and Lucentis for the treatment of macula oedema (swelling at the back of the eye) that has occurred as a result of a central retinal vein occlusion, compared to the published results of Lucentis treatment only.

Phase 4

Active, not recruiting

• Conditions: Maucula oedema secondary to central retinal vein occlusion.; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12615001094561
• Lead Sponsor: ions Eye Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-19
• Last Update Posted: 5 August 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Foveal centre involved perfused macular oedema secondary to CRVO.
2. Mean central foveal thickness greater or equal to 250 microns on spectral domain OCT.
3. Adults greater or equal to 18 years.
4. Clear ocular media and adequate pupillary dilation.
5. IOP less or equal to 25mmHg.
6. Written informed consent.
7. No other significant pathology.
8. Willing, committed and able to return for all clinic visits and complete all study related procedures.
9. Patients who have had a previous CRVO that has spontaneously resolved will be enrolled provided there is no evidence of macular damage that would confuse visual acuity improvements.

Exclusion Criteria

1. Brisk afferent pupillary defect.
2. Evidence on examination of any diabetic retinopathy.
3. CVA or MI within 3 months prior to Baseline.
4. Women of childbearing potential not using the contraception method(s) specified in this study, as well as women who are breastfeeding.
5. Known sensitivity to study drug(s) or class of study drug(s).
6. Use of any other investigational agent in the last 30 days.
7. 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.
8. Neovascularisation of the iris, disc or retina.
9. Aphakia or presence of anterior chamber lens in the study eye.
10. Significant media opacities such as cataract.
11. Previous pars plana vitrectomy.
12. History of retinal detachment or surgery for retinal detachment.
13. 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.
14. Any active infection involving ocular adnexa including infectious conjunctivitis, keratitis, sclertitis, endophthalmitis as well as idiopathic or autoimmune associated uveitis in either eye.
15. Extra capsular 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.).
16. Contra indication to pupil dilation in either eye.
17. Anticoagulation with warfarin or other significant anticoagulation drugs.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compare the number of injections required in the combination treatment of laser bypass (L-CRA) and Lucentis in this study to published studies using monotherapy Lucentis (CRUISE, HORIZON and RETAIN studies). [ Month 24 after the L-CRA treatment. ]