Bevacizumab intravitreal injection in the treatment of patients with Central Retinal Vein Occlusion.

A 12 month, phase 2, single-centre, masked, randomised, sham-controlled trial to assess the safety and efficacy of a 1.25mg/0.05ml Bevacizumab intravitreal injection in the treatment of patients with Central Retinal Vein Occlusion (CRVO).

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000300976

Enrollment

Registered

2011-03-22

Start date

2009-02-23

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary objective of this randomized controlled trial is to evaluate the efficacy of intravitreal Bevacizumab in the treatment of macular oedema following central retinal vein occlusion.

Interventions

The patient will receive an intravitreal injection at baseline, week 4 and week 8. Repeat injections will be decided on an as needed basis The dosage for Bevacizumab is 1.25mg/0.05ml administered via a intravitreal injection into the eye.The procedure will take 5 minutes in total.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Age>18 years, Males and females, Patients presenting with macular oedema secondary to CRVO. BCVA of 20/40 to 20/320 in the study eye

Exclusion criteria

Subjects that have used other investigational drug for last 30 days or 5 half-lives (whichever is longer) Adequate renal function (glomerular filtration calculated by Cockcroft/Gault formula or measure urine creatinine clearance greater than or equal to 50 mL/minute) Diabetic retinopathy with clinically significant macular oedema. Retreatment in therapy associated with severe vision loss; unstable heart disease, uncontrolled hypertension; pregnancy, lactation, children History of submacular surgery or other surgical intervention for AMD in the study eye, glaucoma filtration surgery, corneal transplant surgery, 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, etcetera), History of uncontrolled glaucoma in the study eye (defined as intraocular pressure 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 precluding evaluation of the eye 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)

Outcome results