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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05966493 | A Study to Evaluate the Safety and Efficacy of NEXAGON® (Lufepirsen Ophthalmic Gel) in Subjects With PCED | PHASE2 | RECRUITING | 84 | — | — | Aug 17, 2023 | Dec 1, 2025 | Jul 24, 2025 | 28 | United States, Germany +2 |
The proportion of subjects achieving corneal re-epithelialization that is maintained for a minimum of 28 days, based on assessment of corneal fluorescein staining images of the PCED by a Central Reading Center (CRC).
| Arm | Type | Description |
|---|---|---|
| NEXAGON® (lufepirsen ophthalmic gel) High Dose Concentration | EXPERIMENTAL | Lufepirsen (High dose concentration) applied topically to the eye once a week for a minimum of 4 weeks to a maximum of 8 weeks. |
| NEXAGON Vehicle (ophthalmic gel) | PLACEBO_COMPARATOR | Vehicle applied topically to the eye once a week for a minimum of 4 weeks to a maximum of 8 weeks. |
| NEXAGON® (lufepirsen ophthalmic gel) Low Dose Concentration (EU sites only) | EXPERIMENTAL | Lufepirsen (Low dose concentration) applied topically to the eye once a week for a minimum of 4 weeks to a maximum of 8 weeks. (EU sites only). |
| Name | Type | Description |
|---|---|---|
| lufepirsen high dose | DRUG | Lufepirsen is an unmodified connexin43 antisense oligonucleotide. |
| Vehicle | DRUG | Matching vehicle without lufepirsen. |
| lufepirsen low dose | DRUG | Lufepirsen is an unmodified connexin43 antisense oligonucleotide. |
Inclusion Criteria: 1. Have a PCED that is at least 2 weeks in duration and refractory to one or more conventional non-surgical standard of care (SOC) treatments 2. Have no clinical evidence of improvement in the PCED within 2 weeks prior to randomization despite the use of non-surgical SOC treatme...