Study to Assess the Efficacy and Safety of Brolucizumab 6mg Compared to Aflibercept 2 mg in a Treat-to-control Regimen (TALON)
Condition: Age-related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: Brolucizumab 6 mg; Aflibercept 2 mg
Intervention description: Intra-vitreal injection; Intra-vitreal injection
Intervention MeSH terms: Aflibercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double arm, multi-center
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 734.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Age-related Macular Degeneration; Macular Degeneration; Wet Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; AMD; nAMD; wet AMD; RTH258; Brolucizumab; double blind; age-related macular degeneration (ARMD); vision loss; macula damage; retina damage; dry macular degeneration; Subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration

Summary:

      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.
    

Eligibility criteria:

        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.