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

Completed · Phase 3

Conditions studied: Age-related Macular Degeneration

In brief

This was a 64-week randomized, double-masked, multi-center, active-controlled, two-arm study in patients with neovascular age related macular degeneration (nAMD) who have not previously received anti- vascular endothelial growth factor (VEGF) treatment.

Key facts

Study ID

NCT04005352

Run by

Novartis Pharmaceuticals

People needed

734

Starts

2019-09-25

Expected to finish

2022-09-09

Last updated by the study team

2024-10-09

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Novartis Investigative Site — Huntington Beach, California, United States
• Novartis Investigative Site — Loma Linda, California, United States
• Novartis Investigative Site — Riverside, California, United States
• Novartis Investigative Site — Santa Ana, California, United States
• Novartis Investigative Site — Fort Lauderdale, Florida, United States
• Novartis Investigative Site — Fort Myers, Florida, United States
• Novartis Investigative Site — Orlando, Florida, United States
• Novartis Investigative Site — Pinellas Park, Florida, United States
• Novartis Investigative Site — Winter Haven, Florida, United States
• Novartis Investigative Site — Springfield, Illinois, United States
• Novartis Investigative Site — Indianapolis, Indiana, United States
• Novartis Investigative Site — West Des Moines, Iowa, United States
• Novartis Investigative Site — Minneapolis, Minnesota, United States
• Novartis Investigative Site — Hickory, North Carolina, United States
• Novartis Investigative Site — Portland, Oregon, United States
• Novartis Investigative Site — Springfield, Oregon, United States
• Novartis Investigative Site — Germantown, Tennessee, United States
• Novartis Investigative Site — Austin, Texas, United States
• Novartis Investigative Site — Bellaire, Texas, United States
• Novartis Investigative Site — Fort Worth, Texas, United States
• Novartis Investigative Site — Houston, Texas, United States
• Novartis Investigative Site — Houston, Texas, United States
• Novartis Investigative Site — San Antonio, Texas, United States
• Novartis Investigative Site — Caba, Buenos Aires, Argentina
• Novartis Investigative Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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