Branch Retinal Vein Occlusion Treatment Trial

Phase 3

Recruiting

• Conditions: Branch Vein Retinal Occlusion; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12611000302954
• Lead Sponsor: Royal Adelaide Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-03-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome measure - Best Corrected Visual Accuity log MAR<br>BCVA will be measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) method. BCVA will be measured in both eyes at the baseline visit and at each follow up visit[Baseline then monthly for 12 months]