Phase 4
Completed N=199
Evaluation of the XEN Implant in Moderate Primary Open Angle Glaucoma (POAG) Participants
Source: ClinicalTrials.gov NCT02006693 ↗Enrolled (actual)
199
Serious AEs
8.3%
Results posted
Apr 2019
Primary outcomePrimary: Change From Baseline in Mean Intraocular Pressure (IOP) in the Study Eye to Month 12 — 21.7; 21.0; -6.6; -6.4 mmHg
◆ Published Evidence
Highly cited
215citations · ~31 / year
Two-year results of a multicenter study of the ab interno gelatin implant in medically uncontrolled primary open-angle glaucoma.
Summary
The objective of this study was to evaluate the AqueSys XEN Implant [XEN® Gel Stent (XEN45 Implant)] for the treatment of moderate primary open angle glaucoma (POAG) participants when medications have failed to control intraocular pressure (IOP). Effectiveness was evaluated by comparing medicated preoperative IOP to postoperative values. Additionally, the number of topical IOP-lowering medications at screening were compared to the number of IOP-lowering medications at 1 year.
Linked Publications (2)
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Two-year results of a multicenter study of the ab interno gelatin implant in medically uncontrolled primary open-angle glaucoma.
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An innovation in glaucoma surgery: XEN45 gel stent implantation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Intraocular Pressure (IOP) in the Study Eye to Month 12 |
21.7; 21.0; -6.6; -6.4 | — |
| PRIMARY Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 12 |
2.7; 2.5; -1.8; -1.6 | — |
| PRIMARY Mean Change From Baseline in IOP in the Study Eyes to Month 24 |
21.7; 21.0; -6.4; -5.9 | — |
| PRIMARY Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 24 |
2.7; 2.5; -1.5; -1.5 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of primary open angle glaucoma
- Participants are taking at least one and no more than four topical IOP-lowering medications.
Exclusion Criteria
- Angle Closure Glaucoma
- Participant has neovascular, uveitic or angle recession glaucoma or any glaucoma associated with vascular disorders
- Clinically significant inflammation or infection in the study eye within 30 days prior to the preoperative visit (e.g., blepharitis, conjunctivitis, keratitis, uveitis, herpes simplex infection)
- Presence of conjunctival scarring or prior conjunctival surgery or other conjunctival pathologies (e.g., pterygium) in the target quadrant
Data sourced from ClinicalTrials.gov (NCT02006693) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.