The brolucizumab anti-vascular endothelial growth factor (anti-VEGF) treatment of Age-Related Macular Degeneration (AMD) Switch Study,
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 Verma
50 participants
May 31, 2021
Interventional
Conditions
Summary
This is an open label study in patients: previously treated with intravitreal ranibizumab or aflibercept for at least six months; on a 4 to 8 weekly injection regimen with at least one failed attempt to extend their treatment interval; who have persistent retinal fluid at their current treatment interval or have recurrent retinal fluid if the treatment interval is extended. Eligible participants will switch their study eye treatment to bevacizumab and have three, monthly, loading doses before commencing a treat and extend regimen where the treatment interval will be extended based on the investigators assessment of disease activity and predetermined criteria normally used in clinical practice. The study will run for 18 months: Six months recruitment with a 12 month treatment period) Following enrolment participants will be evaluated monthly. At each follow up they will have a clinical ophthalmic examination including intra-ocular pressure measurement, assessment of best corrected visual acuity, macular OCT and fundus photography. A quality of life questionnaire (NEI VQF-25) will be completed at baseline and at study. completion. Fluorescein angiography will be performed when clinically indicated.
Eligibility
Inclusion Criteria7
- 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.
Exclusion Criteria17
- 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.
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Interventions
The study treatment will be administered by one of the study doctors (opthalmologists) who are all experienced in administering intravitreal injection procedures. The study treatment will be provided in pre-filled syringes containing 0.165 ml of brolucizumab at a concentration of 120 mg per mL (19.8 mg in total). The treating ophthalmologist will inject 6 mg/0.05 ml of brolucizumab into the vitreous cavity. Eligible participants will be treated with three (loading) doses of 6mg intravitreal brolucizumab at day 0, week 4 and week 8. Thereafter they will be treated according to a treat and extend regimen where the treatment interval will be extended based on the investigators assessment of active disease activity based on predetermined criteria normally used in clinical practice: • the presence of retinal fluid on optical coherence tomography (SD-OCT) or • evidence of any new retinal haemorrhage and/or • a reduction in vision (BCVA) of 5 letters or more (deemed attributable to wAMD) since commencing the study. A participant’s treatment interval may be extended by two weeks if none of the above criteria are met. If previously extended the treatment interval may be reduced by two, or four, weeks based on the presence of one or more signs of active disease. The minimum interval between treatments will be 4 weeks. The longest interval between treatments will be 12 weeks.
Locations(1)
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ACTRN12621000624886