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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06495918 | Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age- Related Macular Degeneration | PHASE3 | ACTIVE NOT_RECRUITING | 825 | — | — | Nov 27, 2024 | Jan 8, 2027 | Jun 17, 2025 | 97 | United States, Argentina +2 |
| NCT06223958 | Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Ocular Therapeutix) (Axitinib Implant) in Subjects With Neovascular Age-Related Macular Degeneration | PHASE3 | ACTIVE NOT_RECRUITING | 344 | — | — | Jan 29, 2024 | Sep 27, 2027 | Apr 18, 2025 | 108 | United States, Argentina +1 |
| NCT03630315 | CLN-0046: Treatment of AMD Subjects With OTX-TKI | PHASE1 | COMPLETED | 29 | — | — | Feb 18, 2019 | Jan 10, 2024 | Jul 10, 2024 | 6 | Australia |
Mean change in Best Corrected Visual Acuity (BCVA) from baseline at Week 48
All adverse events from screening through end of study will be captured
| Arm | Type | Description |
|---|---|---|
| OTX-TKI Re-dose | EXPERIMENTAL | - |
| Aflibercept 2mg on label | ACTIVE_COMPARATOR | - |
| Aflibercept 8mg high dose | OTHER | - |
| OTX-TKI (axitinib implant) | EXPERIMENTAL | - |
| Control | OTHER | - |
| Cohort 1 (Low Dose) | EXPERIMENTAL | Subjects will receive a low dose of OTX-TKI |
| Cohort 2 (Middle Dose) | EXPERIMENTAL | Subjects will receive a middle dose of OTX-TKI. |
| Cohort 3 (High Dose) | EXPERIMENTAL | Subjects will receive a high dose of OTX-TKI. |
| Cohort 3 (Anti-VEGF) | EXPERIMENTAL | Subjects will receive OTX-TKI plus a single anti-VEGF injection |
| Cohort 4 (High Dose) | EXPERIMENTAL | Subjects will receive a high dose of OTX-TKI. |
| Cohort 4 (Anti-VEGF) | EXPERIMENTAL | Subjects will receive OTX-TKI plus a single anti-VEGF injection |
| Name | Type | Description |
|---|---|---|
| OTX-TKI | DRUG | Intravitreal Injection of OTX-TKI |
| Aflibercept | DRUG | Intravitreal Injection of 2mg of aflibercept |
| OTX-TKI (axitinib implant) | DRUG | Intravitreal Injection of OTX-TKI (axitinib implant) |
| Anti-VEGF | DRUG | Standard of care therapy used to block vascular endothelial growth factor |
Inclusion Criteria: * Treatment naïve juxtafoveal and/or SFNV secondary to Neovascular Age- Related Macular Degeneration (nAMD) with leakage involving the fovea in the study eye prior to Screening, or have a diagnosis of Neovascular Age- Related Macular Degeneration (nAMD) in study eye within 3 mon...