Tenecteplase in the acute management of branch retinal vein occlusion.

Phase 2

• Conditions: Branch retinal vein occlusion.; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12615000185561
• Lead Sponsor: ions Eye Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-25
• Study Completion: 2017-11-22
• Last Update Posted: 27 April 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Foveal centre involved macular oedema secondary to BRVO less than 3 weeks in duration.
2. Major supero-temperal or infero-temperal BRVO.
3. Mean central foveal thickness greater or equal to 250 microns on spectral domain OCT.
4. Adults greater or equal to 18 years.
5. Best corrected visual acuity 20/40 to 20/320 (73-24 letters on ETDRS chart).
6. Clear ocular media and adequate pupillary dilation.
7. Intraocular pressure equal or less than 25mmHg.
8. Written informed consent.
9. No other significant ocular pathology.
10. Willing, committed and able to return for all clinic visits and complete all study related procedures.

Exclusion Criteria

1.Any previous treatment for BRVO.
2. Brisk afferent pupillary defect.
3. Evidence on examination of any diabetic retinopathy.
4. Women of child bearing potential not using contraception, as well as women who are breastfeeding.
5. Known sensitivity to study drug or class of study drug.
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, dics or retina.
9. Previous treatment with intravitreal corticosteroids, intravitreal anti-VEGF agents or macular grid laser in the previous 3 months.
10. Aphakia or presence of anterior chamber lens in the study eye.
11. Significant media opacities such as cataract.
12. Previous pars plana vitrectomy.
13. History of retinal detachment or surgery for retinal detachment.
14. 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.
15. Any active infection involving ocular adnexa including infectious conjunctivitis, keratitis, sclertitis, endophthalmitis as well as idiopathic or autoimmune-associated uveitis in either eye.
16. Extra capsular extraction of cataract with phacoemulsification within 3 months preceding baseline, or a history of post-operative complications within 12 months preceding baseline in the study eye (uveitis, cyclitis etc.).
17. Contra indication to pupil dilation in either eye.
18. Allergy to fluorescein.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of intravenous thrombus assessed by OCT. [7 Days post injection. ];Venous outflow in the affected vein assessed using fluorescein angiography and flowmetry. [7 Days post injection. ]

Secondary Outcome Measures

Name	Time	Method
Visual acuity assessed using an ETDRS Lighthouse 4m chart. [One month post injection. ];To evaluate the incidence of the clot reforming using OCT. [One month post injection. ];To measure macular centre point thickness using OCT.[ One month post injection. ]; To evaluate venous outflow in the affected vein using fluorescein angiography and flowmetry.[One month post injection. ]; To determine both the nature and sequence of changes to the radial peripapillary capillaries and the deep capillary networks as a composite secondary outcome using optical coherence tomography angiography (OCTA). [One and Three months post injection.]