Summary

Eligibility
for people ages 50 years and up (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

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)

Keywords

Age-related Macular Degeneration Macular Degeneration Wet Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases AMD, nAMD, wet AMD, RTH258, brolucizumab, double blind Brolucizumab 6 mg Aflibercept 2 mg Brolucizumab Aflibercept

Eligibility

You can join if…

Open to people ages 50 years and up

  • 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 CAN'T join 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.

Other protocol-defined inclusion/exclusion criteria may apply

Locations

  • Novartis Investigative Site accepting new patients
    Sacramento California 95817 United States
  • Novartis Investigative Site accepting new patients
    Ventura California 93003 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
Links
Sign up for this study
ID
NCT04005352
Phase
Phase 3
Study Type
Interventional
Last Updated