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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04005352 | Study to Assess the Efficacy and Safety of Brolucizumab 6mg Compared to Aflibercept 2 mg in a Treat-to-control Regimen (TALON) | PHASE3 | COMPLETED | 734 | — | — | Sep 25, 2019 | Sep 9, 2022 | Oct 9, 2024 | 118 | United States, Argentina +18 |
No disease activity is defined as no change in visual acuity and no change in other signs of the disease (e.g. Intraretinal Fluid (IRF), Subretinal Fluid (SRF), hemorrhage, leakage, etc.). Treatment interval distribution. Number (%) of subjects at 12/8/4-weeks intervals up to Week 32 for the study eye. If the study treatment is discontinued before Week 16, then the treatment interval is 4 weeks; otherwise. the last interval with no disease activity is used (if there was disease activity, the last interval is shortened by 4 weeks, down to a minimum of 4 weeks). If the duration of the last interval falls within the following ranges of (4-week, 8-week) or (8-week, 12-week) or ≥12-week then the floor value of these ranges was used.
BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. Least squares mean estimate - for weeks 28 and 32 combined.
| Arm | Type | Description |
|---|---|---|
| Brolucizumab 6 mg | EXPERIMENTAL | 3 x 4-week injections and one 8-week Intra-vitreal injection, followed by Treat-to- Control treatment from Week 16 up to Week 60/62. |
| Aflibercept 2 mg | ACTIVE_COMPARATOR | 3 x 4-week injections and one 8-week Intra-vitreal injection, followed by Treat-to- Control treatment from Week 16 up to Week 60/62 |
| Name | Type | Description |
|---|---|---|
| Brolucizumab 6 mg | BIOLOGICAL | Intra-vitreal injection |
| Aflibercept 2 mg | BIOLOGICAL | Intra-vitreal injection |
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 angio...