NCT04547036 is a clinical trial of XEN45 in Glaucoma, sponsored by Paracelsus Medical University.

Who is sponsoring NCT04547036?

NCT04547036 is sponsored by Paracelsus Medical University.

What drugs are being tested in NCT04547036?

Interventions in NCT04547036: XEN45.

What condition does NCT04547036 study?

NCT04547036 studies Glaucoma, Endothelial Cell Loss, Corneal.

Is NCT04547036 still recruiting?

NCT04547036 is currently completed. Last updated 13 July 2021.

Are results published for NCT04547036?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-07-13 · How we verify

NCT04547036

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Changes in Corneal Endothelial Cell Density After Transscleral ab Interno Glaucoma Gel Stent Implantation

Completed Results posted Last updated 13 July 2021

What this trial tests

trial testing XEN45 in Glaucoma in 129 participants. Completed in 30 April 2021.

Timeline

30 January 2020

Primary endpoint
31 January 2021

30 April 2021

Quick facts

Lead sponsor	Paracelsus Medical University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	129
Start date	30 January 2020
Primary completion	31 January 2021
Estimated completion	30 April 2021
Sites	1 location across Austria

Drugs / interventions tested

XEN45

Conditions studied

Glaucoma — all drugs for Glaucoma →
Endothelial Cell Loss, Corneal — all drugs for Endothelial Cell Loss, Corneal →

Sponsor

Paracelsus Medical University

Who can join

18 and older, any sex, with Glaucoma or Endothelial Cell Loss, Corneal. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Endothelial Cell Count Change Primary · baseline compared to 1-5 years postoperative

The primary endpoint is the change of central endothelial cell density compared to preoperative data.

1 year

Group	Value	95% CI
Endothelial Cell Count Measurment	2	-1 – 5

2 years

Group	Value	95% CI
Endothelial Cell Count Measurment	-1	-3 – 0

3 years

Group	Value	95% CI
Endothelial Cell Count Measurment	0	-3 – 2

4 years

Group	Value	95% CI
Endothelial Cell Count Measurment	-4	-7 – 1

5 years

Group	Value	95% CI
Endothelial Cell Count Measurment	-1	-7 – 4

Adverse events — posted to ClinicalTrials.gov

Time frame: 3.7 (range 1.6-6.7) years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

XEN45 Implantation With and Without Combined Cataract Surgery

Serious: 0/129 (0%)

Deaths: 0/129

Other adverse events (8 terms — click to expand)

Reaction	System	XEN45 Implantation With an…
Adult Macular degeneration	Eye disorders	—
Conjunctival hyperemia	Eye disorders	—
Retinal haemorrhage	Eye disorders	—
conreal guttae	Eye disorders	—
Conjuncitval emema	Eye disorders	—
Cystoid macular edema	Eye disorders	—
Epiretinal membrane	Eye disorders	—
Conjuncitval hemorhage	Eye disorders	—

Data from ClinicalTrials.gov NCT04547036 adverse events section.

Sponsor's own description

The objective of this study is to evaluate the change of endothelial cell count after XEN45 in patients with or without cataract operation.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of XEN45

Trials testing the same drug.

NCT03362931 — Safety and Effectiveness of the XEN45 Glaucoma Treatment System in Patients With Angle Closure Glaucoma · Phase 3 · completed

Other recruiting trials for Glaucoma

Currently open trials in the same condition.

NCT07455786 — Modified Trabeculectomy After Failure of Combined Phaco With GATT · NA · recruiting
NCT07298356 — Automated Applanation Tonometry - Updated · NA · recruiting
NCT07217678 — Biomarkers of Ocular Surface Damage in the Setting of Topical Ocular Hypotensive Medication Use · Phase 4 · recruiting
NCT07145073 — Repetitive Transcranial Alternating Current Stimulation (rtACS) for the Treatment of Optic Neuropathies · NA · recruiting
NCT07209410 — Evaluating Injection With the Use of Brimonidine Tartrate Ophthalmic 0.025% on Patients Using Netarsudil 0.02%/Latanopro · Phase 4 · recruiting

Other Paracelsus Medical University trials

Trials by the same sponsor.

NCT07315334 — Assessing Functional Impairments in Patients With Chemotherapy-Induced Peripheral Neuropathy · not yet recruiting
NCT04591860 — A Prospective Randomised Multi - Center Trial on the Repair of Large Hiatal Hernias: Absorbable Mesh vs. Pledgeted Sutur · NA · not yet recruiting
NCT06056193 — The SIR-POBA Bypass Trial · NA · withdrawn
NCT06056206 — The SIR-POBA Shunt Trial · NA · withdrawn
NCT05506111 — Low Anterior Resection Syndrome After Rectum Resection for Rectal Carcinoma. · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04547036 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Paracelsus Medical University
Last refreshed: 13 July 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04547036.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing