neovascular age-related macular degeneration MedDRA version: 20.0 Level: PT Classification code 10071129 Term: Neovascular age-related macular degeneration System Organ Class: 10015919 - Eye disorders
Conditions
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Signed informed consent must be obtained prior to participation in the study. 2.Male or female patients, = 50 years of age at screening. Study Eye: 3.Active 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 (or other imaging modalities) and sequellae of CNV, e.g. pigment epithelial detachment (PED), subretinal or sub-retinal pigment epithelium (sub-RPE) hemorrhage, blocked fluorescence, macular edema. 4.Presence of intraretinal fluid (IRF) or subretinal fluid (SRF) that affects the central subfield, as seen by SD-OCT. 5.BCVA score must be = 83 and = 38 letters at an initial testing distance of 4 meters starting distance using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity charts (approximately Snellen equivalent of 20/25 and 20/200), at both screening and baseline. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 346 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 346
Exclusion criteria
Exclusion criteria: 1.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) 2.Any active intraocular or periocular infection or active intraocular inflammation, at screening or baseline (study eye) 3.Uncontrolled glaucoma defined as intraocular pressure (IOP) > 25 mmHg on medication, or according to investigator’s judgment, at screening or baseline (study eye) 4.Presence of amblyopia, amaurosis or ocular disorders in the fellow eye with BCVA < 20/200 at screening (except when due to conditions which can lead to improved VA after surgery eg cataract) 5.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) 6.Stroke or myocardial infarction during the 6-month period prior to baseline 7.Systemic anti-VEGF therapy at any time.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To demonstrate that brolucizumab is superior to aflibercept with respect to the duration of treatment intervals at Week 32 •To demonstrate that brolucizumab is non-inferior to aflibercept with respect to average change in BCVA from baseline at Weeks 28 and 32;Secondary Objective: •To evaluate the durability of brolucizumab relative to aflibercept •To evaluate the functional outcomes with brolucizumab relative to aflibercept •To evaluate the anatomical outcomes with brolucizumab relative to aflibercept •To evaluate the effect of brolucizumab relative to aflibercept on Patient-Reported Outcomes (PRO) •To assess the safety and tolerability of brolucizumab relative to aflibercept ;Primary end point(s): 1.Distribution of the last interval with no disease activity up to Week 32 (if there was disease activity, the last interval will be shortened by 4 weeks, down to a minimum of 4 weeks) 2.Average change in BCVA from baseline at Weeks 28 and 32 ;Timepoint(s) of evaluation of this end point: 1. up to week 32 2. at week 28 and 32 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Distribution of the last interval with no disease activity up to Week 64 (if there was disease activity, the last interval will be shortened by 4 weeks down to a minimum of 4 weeks) 2. Distribution of the maximal intervals with no disease activity up to Week 64 3. Proportion of patients with no disease activity at Weeks 14 and 16 4. Time from the last loading injection to the first visit with no disease activity 5. Average change in BCVA from baseline at Weeks 60 and 64 6. Occurrence of BCVA improvements of = 10 and = 15 letters from baseline at Week 32, Week 64, and at the last injection visit 7. Occurrence of BCVA = 69 letters at Week 32, at Week 64, and at the last injection visit 8. Average change from baseline in CSFT as assessed by SD-OCT at Weeks 28 and 32 9. Average change from baseline in CSFT as assessed by SD-OCT at Weeks 60 and 64 10. Number of visits with presence of IRF and/or SRF, and sub-RPE fluid in the central subfield, as assessed by SD-OCT at Weeks 28 and 32 11. Number of visits with presence of IRF and/or SRF, and sub-RPE fluid in the central subfield as assessed by SD-OCT at Weeks 60 and 64 12. Change in Visual Function Questionnnaire-25 (VFQ-25) total and subscale scores from baseline at Weeks 32 and 64 13. Incidence of Ocular and Non-ocular AEs, vital signs and laboratory values up to Week 64 ;Timepoint(s) of evaluation of this end point: 1. up to Week 64 2. up to Week 64 3. at Weeks 14 and 16 4. Time from the last loading injection to the first visit with no disease activity 5. at Weeks 60 and 64 6. at Week 32, Week 64, and at the last injection visit 7. at Week 32, at Week 64, and at the last injection visit 8. at Weeks 28 and 32 9. at Weeks 60 and 64 10. at Weeks 28 and 32 11. at Weeks 60 and 64 12. at Weeks 32 and 64 13. up to Week 64 | — |
Countries
Argentina, Australia, Austria, Belgium, Canada, Czechia, Czech Republic, France, Germany, Israel, Italy, Korea, Republic of, Malaysia, Netherlands, Portugal, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
Contacts
Public ContactClinical Trial Information Desk
Novartis Farma - Produtos Farmacêuticos, S.A.
Outcome results
None listed