Study to Assess the Efficacy and Safety of Brolucizumab 6mg Compared to Aflibercept 2 mg in a Treat-to-control Regimen (TALON)

  • STATUS
    Recruiting
  • End date
    Jan 6, 2023
  • participants needed
    692
  • sponsor
    Novartis Pharmaceuticals
Updated on 18 September 2021
Investigator
Novartis Pharmaceuticals
Primary Contact
Novartis Investigative Site (0.0 mi away) Contact
+135 other location
angiography
edema
vegf
growth factor
bevacizumab
vascular endothelial growth factor
neovascularization
retinopathy
diabetic retinopathy
corrected visual acuity
macular edema
fluorescein angiography
retinal pigment
retinal angiomatous proliferation
aflibercept
optical coherence tomography
spectral domain optical coherence tomography
detachment
age-related macular degeneration
macular degeneration
pigment epithelial detachment
brolucizumab
choroidal neovascularization

Summary

The study is a 64-week randomized, double-masked, multi-center, active-controlled, two-arm study in patients with nAMD (neovascular age related macular degeneration) who have not previously received anti-VEGF (vascular endothelial growth factor) treatment. Patients who consent will undergo screening assessments to evaluate their eligibility based on the inclusion and exclusion criteria.

Details
Condition Wet Macular Degeneration, Retinal Degeneration, Retinopathy, EYE DISORDER, age-related macular degeneration, Eye Disorders/Infections, Dry Eye Disease, Maculopathy, Eye Disorders/Infections (Pediatric), Macular Degeneration, Eye Disease, ocular disease, ophthalmological disorder, retinal disease, retinopathies, retinal diseases
Treatment Brolucizumab 6 mg, Aflibercept 2 mg
Clinical Study IdentifierNCT04005352
SponsorNovartis Pharmaceuticals
Last Modified on18 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 at both screening and baseline visit (study eye)

Exclusion Criteria

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)
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
Other protocol-defined inclusion/exclusion criteria may apply
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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