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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02355028 | LHA510 Proof-of-Concept Study as a Maintenance Therapy for Patients With Wet Age-Related Macular Degeneration | PHASE2 | COMPLETED | 136 | — | — | Mar 3, 2015 | Oct 18, 2016 | Jul 2, 2018 | 1 | United States |
For subjects who completed the Day 84 visit, retreatment need status was positive if LUCENTIS® retreatment (injection) was required before or at Day 84, including requiring retreatment at or before the Day 84 visit with the actual retreatment performed at a later visit.
| Arm | Type | Description |
|---|---|---|
| LHA510 | EXPERIMENTAL | LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy. |
| Vehicle | PLACEBO_COMPARATOR | LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy. |
| Name | Type | Description |
|---|---|---|
| LHA510 ophthalmic suspension | DRUG | - |
| LHA510 vehicle | DRUG | Inactive ingredients used as a placebo comparator |
| Ranibizumab ophthalmic solution | DRUG | For intravitreal (IVT) injection |
Inclusion Criteria: * Sign written informed consent form; * Wet AMD; * IVT anti-VEGF therapy for at least 6 months and a maximum of 7 years since the 3rd loading dose; * BCVA 50 letters (approximate Snellen equivalent 20/100) or better in the study eye; * Demonstrate ability to administer eye drops...