A twelve month, unmasked, prospective study evaluating the effectiveness of the anti-VEGF brolucizumab to increase the interval between treatments, while controlling disease activity, in subjects with neovascular AMD resistant to extension of current anti-VEGF treatment beyond 4 to 8 weeks.

Clinical Professor Nitin Verma0 个研究点目标入组 50 人开始时间: 2021年5月24日最近更新: 2021年11月22日

适应症

试验速览

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•Ability to provide written informed consent and complete study assessments
•Age 50 years or older
•Confirmed diagnosis of CNV secondary to AMD
•Best corrected visual acuity between 6/6 and 6/60 (85-35 letters), on Early Treatment Diabetic Retinopathy (ETDRS) charts, at baseline
•Currently being treated with regular, approximately 4-8 weekly, intravitreal anti-VEGF injections, for a minimum of six months
•At least one attempt at extending their anti-VEGF treatment regimen beyond the current dosing interval
•SD-OCT evidence of IR, SR, sub RPE fluid or cystoid oedema (but not intra-retinal cysts alone) less than 60 days since last anti-VEGF injection OR who have had a recurrence of IR, SR, sub RPE fluid or cystoid oedema when treatment intervals are extended.

•Pregnant or nursing (lactating) women
•Pre or peri-menopausal women not using contraception
•Prior anti-VEGF injection in the study eye within 30 days of baseline
•Prior treatment with photo dynamic therapy (PDT) within 90 days of baseline and more than 6 prior PDT treatments
•Significant sub retinal fibrosis, atrophy or other structural change in the retina that might affect the study outcomes.
•Prior treatment with intravitreal steroid treatment in the study eye within 6 months of baseline
•Intraocular surgery in the study eye within 3 months of baseline ( excepting cataract surgery)
•Prior vitrectomy or other surgical intervention for AMD in the study eye
•Current vitreous haemorrhage or active intraocular inflammation in the study eye
•Uncontrolled glaucoma in the study eye. Intraocular pressure (IOP) greater than 30mmHg on maximal medical therapy.
•History of stroke, acute myocardial infarction and transient ischemic attack within 3 months of study enrolment
•Allergy to fluorescein.
•Known intolerance to brolucizumab or any of its constituents
•Concurrent use of systemic or intravenous anti-VEGF agents
•Use of any medications known to be toxic to the eye (except for those used short term for the treatment of COVID-19 infection)
•Use of any other unstable medical condition that may potentially affect the study outcomes or the participant’s ability to participate in the study.
•Participation in any other clinical trials.

发起方

Clinical Professor Nitin Verma