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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06822738 | A Study to Assess Adverse Events and Effectiveness of Gel Stent (XEN63) Implantation Using Ab Interno and Ab Externo Approaches in Adult Participants With Glaucoma | PHASE3 | RECRUITING | 130 | — | — | Feb 11, 2025 | Nov 1, 2028 | Jun 1, 2026 | 24 | United States |
IOP is a measurement of the fluid pressure inside the study eye. Treatment response is defined as IOP reduction on the same or fewer number of topical IOP-lowering medications.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
| Arm | Type | Description |
|---|---|---|
| XEN63 Ab Externo | EXPERIMENTAL | Participants will be implanted with XEN63 via ab externo surgical approach in the study eye. Participants will be followed for up to 12 months. |
| XEN63 Ab Interno | EXPERIMENTAL | Participants will be implanted with XEN63 via ab interno surgical approach in the study eye. Participants will be followed for up to 12 months. |
| Name | Type | Description |
|---|---|---|
| XEN63 Glaucoma Treatment System | DEVICE | Gel Stent |
Inclusion Criteria: * Diagnosis of glaucoma in the study eye (SE) (meeting criterion a or b) 1. That meets the following refractory glaucoma criteria of eyes diagnosed with glaucoma uncontrolled by maximal medical therapy (four or more classes of intraocular pressure (IOP)-lowering medications, ...