A 64-week, two-arm, randomized, double-masked, multicenter, phase IIIb study assessing the efficacy and safety of brolucizumab 6 mg compared to aflibercept 2 mg in a treat-to-control regimen in patients with neovascular agerelated macular degeneration (TALON)
- Conditions
- nAMDwet age-related macular degeneration10047518
- Registration Number
- NL-OMON49739
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 14
- Signed informed consent must be obtained prior to participation in the study
- Male or female patients * 50 years of age at screening who are treatment
naive
- Active choroidal neovascularization (CNV) secondary to AMD that affects the
central subfield, including retinal angiomatous proliferation (RAP) with a CNV
component, confirmed by presence of active leakage from CNV seen by fluorescein
angiography and sequellae of CNV, e.g. pigment epithelial detachment (PED),
subretinal or sub-retinal pigment epithelium (sub-RPE) hemorrhage, blocked
fluorescence, macular edema (study eye)
- Presence of intraretinal fluid (IRF) or subretinal fluid (SRF) that affects
the central subfield, as seen by Spectral Domain Optical Coherence Tomography
(SD-OCT) (study eye)
- Best-corrected visual acuity (BCVA) score between 83 and 38 letters,
inclusive, using Early Treatment Diabetic Retinopathy Study (ETDRS) visual
acuity testing charts (approximate Snellen equivalent of 20/25 to 20/200) at
both screening and baseline visit (study eye)
- Ocular conditions/disorders at screening or baseline which could, in the
opinion of the investigator, prevent response to study treatment or may
confound interpretation of study results, compromise visual acuity or require
planned medical or surgical intervention during the first 12-month study
period, structural damage of the fovea, atrophy or fibrosis at the center of
the fovea (study eye)
- Any active intraocular or periocular infection or active intraocular
inflammation, at screening or baseline (study eye)
- Uncontrolled glaucoma defined as intraocular pressure (IOP) > 25 mmHg on
medication, or according to investigator*s judgment, at screening or baseline
(study eye)
- Presence of amblyopia, amaurosis or ocular disorders in the fellow eye with
BCVA < 20/200 at screening (except when due to conditions which can lead to
improved VA after surgery eg cataract)
- Ocular treatments: previous treatment with any anti-vascular endothelial
growth factor (VEGF) drugs or investigational drugs, intraocular or periocular
steroids, macular laser photocoagulation, photodynamic therapy, vitreoretinal
surgery, intraocular surgery (study eye)
- Stroke or myocardial infarction during the 6-month period prior to baseline
- Systemic anti-VEGF therapy at any time.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To demonstrate that brolucizumab is superior to aflibercept with respect to the<br /><br>duration of treatment intervals at Week 32<br /><br>To demonstrate that brolucizumab is non-inferior to aflibercept with respect to<br /><br>average change in best corrected visual acuity (BCVA) from baseline at Weeks 28<br /><br>and 32</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. To evaluate the durability of brolucizumab relative to aflibercept<br /><br>2. To evaluate the functional outcomes with brolucizumab relative to aflibercept<br /><br>3. To evaluate the anatomical outcomes with brolucizumab relative to aflibercept<br /><br>4. To evaluate the effect of brolucizumab relative to aflibercept on<br /><br>Patient-Reported Outcomes (PRO)<br /><br>5. To assess the safety and tolerability of brolucizumab relative to<br /><br>aflibercept</p><br>