Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02434328 | Efficacy and Safety of RTH258 Versus Aflibercept - Study 2 | PHASE3 | COMPLETED | 1,048 | — | — | Jul 28, 2015 | Mar 8, 2018 | Jan 16, 2025 | - | — |
| NCT02307682 | Efficacy and Safety of RTH258 Versus Aflibercept - Study 1 | PHASE3 | COMPLETED | 1,775 | — | — | Dec 8, 2014 | Mar 28, 2018 | Jan 16, 2025 | 1 | United States |
| NCT02507388 | Safety and Pharmacokinetics of RTH258 in Subjects With Age-Related Macular Degeneration | PHASE2 | COMPLETED | 51 | — | — | Aug 24, 2015 | Sep 6, 2016 | Jul 2, 2018 | - | — |
BCVA (with spectacles or other visual corrective devices) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.
Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental pharmacokinetic (PK) method.
Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental pharmacokinetic (PK) method.
Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental pharmacokinetic (PK) method.
Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental pharmacokinetic (PK) method.
Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental pharmacokinetic (PK) method.
Serum concentration at the specified collection time point was quantitated, where possible, using a validated immunoassay method. The data were analyzed using a noncompartmental pharmacokinetic (PK) method.
Serum concentration at the specified collection time point was quantitated, where possible, using a validated immunoassay method. The data were analyzed using a noncompartmental pharmacokinetic (PK) method.
| Arm | Type | Description |
|---|---|---|
| Brolucizumab 6 mg | EXPERIMENTAL | Single intravitreal (IVT) injection of brolucizumab at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit |
| Aflibercept 2 mg | ACTIVE_COMPARATOR | Single IVT injection of aflibercept ophthalmic solution at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit |
| Brolucizumab 3 mg | EXPERIMENTAL | Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit |
| Name | Type | Description |
|---|---|---|
| Brolucizumab ophthalmic solution | DRUG | Ophthalmic solution for IVT injection administered as a 6 mg/50 µL dose |
| Aflibercept ophthalmic solution | DRUG | Ophthalmic solution for IVT injection administered as a 2 mg/50 µL dose |
| Brolucizumab 3 mg/50 μL | DRUG | Administered as an intravitreal injection |
| Brolucizumab 6 mg/50 μL | DRUG | Administered as an intravitreal injection |
Key Inclusion Criteria: * Provide written informed consent; * Active CNV lesions secondary to AMD that affected the central subfield in the study eye at Screening; * Total area of CNV \> 50% of the total lesion area in the study eye at Screening; * Intraretinal and/or subretinal fluid affecting the...