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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01849692 | ESBA1008 Microvolume Study | PHASE2 | COMPLETED | 107 | — | — | Jun 1, 2013 | Jan 1, 2015 | Mar 24, 2016 | - | — |
| NCT01796964 | Efficacy and Safety Study of ESBA1008 Versus EYLEA® | PHASE2 | COMPLETED | 173 | — | — | Mar 1, 2013 | Aug 1, 2014 | Feb 9, 2016 | - | — |
| NCT01304693 | ESBA1008 Safety, Tolerability and Effects in Wet Age-Related Macular Degeneration (AMD) Patients | PHASE1 | COMPLETED | 376 | — | — | Oct 1, 2010 | Mar 1, 2013 | Jul 17, 2014 | - | — |
A subject was considered a responder if at least 3 out of the following 4 criteria were fulfilled in comparison to baseline: * Greater than or equal to 4 letter gain in BCVA at Day 14 * Greater than or equal to 4 letter gain in BCVA at Day 28 * Greater than or equal to 80 micron decrease in CSFT at Day 14 * Greater than or equal to 80 micron decrease in CSFT at Day 28. BCVA was measured by the number of letters read out of a possible 70 letters on the ETDRS chart. One eye (study eye) contributed to the analysis.
This outcome measure was used to compare the ESBA1008 and EYLEA groups in regards to fluctuations in treatment effect during the maintenance phase with 8-week treatment cycles (ie, to evaluate treatment effect stability during the maintenance phase). BCVA (with spectacles or other visual corrective devices) using Early Treatment Diabetic Retinopathy Study (ETDRS) testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.
CSFT is a retinal thickness measurement and was measured with SD-OCT. A thickening of the retina is characteristic of wet AMD, and a reduction in CSFT may indicate an improvement in ocular health. One eye (ie, study eye) contributed to the mean.
| Arm | Type | Description |
|---|---|---|
| ESBA1008 1.2 mg/10 μL | EXPERIMENTAL | Cohort 1: One intravitreal injection on Day 0, followed by one intravitreal (IVT) injection of ESBA1008 6 mg/50 μL on Day 28 |
| ESBA1008 1 mg/8.3 μL | EXPERIMENTAL | Cohort 2: One intravitreal infusion on Day 0, followed by one intravitreal injection of ESBA1008 6 mg/50 μL on Day 28 |
| ESBA1008 0.6 mg/10 μL | EXPERIMENTAL | Cohort 3: One intravitreal injection on Day 0, followed by one intravitreal injection of ESBA1008 6 mg/50 μL on Day 28 |
| ESBA1008 0.5 mg/8.3 μL | EXPERIMENTAL | Cohort 4: One intravitreal infusion on Day 0, followed by one intravitreal injection of ESBA1008 6 mg/50 μL on Day 28 |
| Ranibizumab 0.5 mg in 50 μL | ACTIVE_COMPARATOR | Cohorts 1-4: One intravitreal injection on Day 0, followed by another intravitreal injection on Day 28 |
| ESBA1008 | EXPERIMENTAL | ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol |
| EYLEA | ACTIVE_COMPARATOR | Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol |
| LUCENTIS | ACTIVE_COMPARATOR | Ranibizumab 0.5 mg, single intravitreal injection |
| Name | Type | Description |
|---|---|---|
| ESBA1008 solution | DRUG | Intravitreal injection or infusion |
| Ranibizumab | DRUG | Intravitreal injection |
| Aflibercept | DRUG | For intravitreal (IVT) injection |
| Ranibizumab 0.5 mg | BIOLOGICAL | Administered as a single intravitreal injection |
Inclusion Criteria: * Sign informed consent document; * Able to make the required study visits and follow instructions; * Age-related macular degeneration in the study eye; * Visual acuity within protocol-specified range; * 340 μm minimal central subfield thickness (CSFT; Spectralis Equivalent) * O...