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
Interventions
Trade Name: Beovu 120 mg/ml Injektionslösung in einer Fertigspritze
Product Name: Beovu 120 mg/ml Injektionslösung in ener Fertigspritze
Product Code: RTH258 formerly ESBA1008
Pharmaceutical Form: Sol
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Signed informed consent - Male or female patients, = 50 years of age at screening. Study eye: 3. Active choroidal neovascularization (CNV) secondary to AMD 4. Previous treatment with any licensed anti-VEGF drug for = 6 months in a = q6w to = q10w injection interval with residual or recurrent fluid 5. BCVA score must be = 83 and = 38 letters at 4 meters starting distance using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity charts 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 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: 1. Concomitant conditions or ocular disorders in the study eye 2. Treatment with anti-VEGF drugs for > 36 months. 3. Any active intraocular or periocular infection or active intraocular inflammation 4. Uncontrolled glaucoma in the study eye 5. Presence of amblyopia, amaurosis or ocular disorders in the fellow eye 6. Atrophy or fibrosis involving the center of the fovea in the study eye 7. The total area of fibrosis or subretinal blood affecting the foveal center point comprising = 50% of the lesion area as well as chronic cystic lesions in the study eye 8. Structural damage within 0.5 disc diameter of the center of the macula in the study eye
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary: To demonstrate that brolucizumab 6 mg with one (initial) injection followed by q12w maintenance is noninferior to brolucizumab 6 mg with 3x q4w loading injections followed by q12w maintenance;Secondary Objective: - To evaluate treatment interval prolongation compared to previous treatment - To estimate the proportions of patients maintained at q12w Treatment frequency in the two brolucizumab groups - To evaluate the functional outcomes comparing the two brolucizumab groups - To evaluate the anatomical outcomes comparing the two brolucizumab groups - To assess the safety and tolerability of brolucizumab;Primary end point(s): Mean change in BCVA from baseline to mean of visits at week 40 to week 52 (non-inferiority margin -4 ETDRS letters);Timepoint(s) of evaluation of this end point: week 40 to week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Mean treatment interval (overall as well as per study group comparing treatment intervals from baseline to week 52 in the study vs. 24 weeks to baseline prior to enrollment) - Rate of patients (overall and per group) with prolonged interval compared to mean treatment interval in last 24 weeks prior to enrollment - Comparison of proportions of patients maintained at a q12w interval at week 52 between the two arms - Distributions of patients at q8w/q12w intervals from baseline to week 52 - Average change in BCVA from baseline to week 52 - Proportions of patients with BCVA improvements of =5, = 10, and = 15 letters from baseline to week 52 - Proportions of BCVA = 69 letters at week 52 ? - Mean change in BCVA from baseline to mean of visits week 16 to week 28 - Change from baseline in CST - Absence of IRF, SRF, and sub-RPE fluid - Presence of active CNV leakage - Incidence of ocular and non-ocular AEs up to week 52;Timepoint(s) of evaluation of this end point: from baseline to week 52 | — |
Countries
Germany, Switzerland
Contacts
Public ContactMedizinischer Infoservice (MCC)
Novartis Pharma GmbH
Outcome results
None listed