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Study to Assess the Efficacy and Safety of Brolucizumab 6mg Compared to Aflibercept 2 mg in a Treat-to-control Regimen (TALON)
Overall Recruitment Status: Active, currently enrolling
 
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)
 
Region Sponsors
California - Southern
Norvartis
 
Acronym KP IRB No.
12329
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Individuals with diagnosis of Age-related Macular Degeneration, Macular Degeneration, Wet Macular Degeneration, Retinal Degeneration, Retinal Diseases, Eye Diseases
 
Purpose
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.
 
Detailed Description
Average change in Best-corrected visual acuity. Time Frame: At Weeks 28 and 32. Visual acuity test. Distribution of the last interval with no disease activity. Time Frame: Up to Week 32. Treatment interval distribution.
 
Gender Age Limit
Male & Female
 
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 na├»ve
  • 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. Please contact study team

 
Keywords and/or Specific Medical Conditions
  • Eye Diseases
  • Retinal Degeneration Wet Macular Degeneration
  • Eye Diseases, Hereditary
  • Retinal Diseases
  • Macular Degeneration
  • Ophthalmology
 
KP Clinical Facility
  • Riverside
 
Clinical Area
  • Ophthalmology


Principal Investigator:
Vivienne Hau, MD
Contact Information:
- Tiffany Castanon
-626-564-5667
-Riverside


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