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NCT04542616: B350vsCP250

Baerveldt 350 vs Ahmed ClearPath 250 for the Treatment of Glaucoma

Completed NA Results posted Last updated 17 April 2026
What this trial tests

NA trial testing Baerveldt 350 vs. Ahmed ClearPath 250 tube shunt implantation in Glaucoma in 80 participants. Completed in 31 July 2024.

Timeline
13 August 2020
Primary endpoint
31 July 2024
31 July 2024

Quick facts

Lead sponsorState University of New York at Buffalo
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment80
Start date13 August 2020
Primary completion31 July 2024
Estimated completion31 July 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

State University of New York at Buffalo

Who can join

18 and older, any sex, with Glaucoma. 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.

Intraocular Pressure (IOP) Primary · Baseline, Month 1, Month 3, Month 6, Month 12, Month 24

Mean IOP in each treatment group at the above time points

Baseline
GroupValue95% CI
Baerveldt 35022.58± 8.62
Ahmed ClearPath 25020.95± 7.00
Month 1
GroupValue95% CI
Baerveldt 35015.0± 4.8
Ahmed ClearPath 25015.1± 4.8
Month 3
GroupValue95% CI
Baerveldt 35011.7± 4.7
Ahmed ClearPath 25012.1± 4.3
Month 6
GroupValue95% CI
Baerveldt 35011.3± 4.3
Ahmed ClearPath 25012.2± 5.3
Month 12
GroupValue95% CI
Baerveldt 35010.0± 3.7
Ahmed ClearPath 25012.0± 4.4
Month 24
GroupValue95% CI
Baerveldt 35010.9± 4.0
Ahmed ClearPath 25013.6± 3.7

Adverse events — posted to ClinicalTrials.gov

Time frame: 24 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Baerveldt 350
Serious: 1/38 (3%)
Deaths: 1/38
Ahmed ClearPath 250
Serious: 1/40 (3%)
Deaths: 1/40

Serious adverse events (1 terms)

ReactionSystemBaerveldt 350Ahmed ClearPath 250
Myocardial Infarction/Cardiac Arrest (heart attack)*Cardiac disorders
Other adverse events (1 terms — click to expand)

ReactionSystemBaerveldt 350Ahmed ClearPath 250
Surgical failureSurgical and medical procedures

Most-reported serious reactions: Myocardial Infarction/Cardiac Arrest (heart attack)*.

Data from ClinicalTrials.gov NCT04542616 adverse events section.

Sponsor's own description

To compare the safety and efficacy of Baerveldt 350 and Ahmed ClearPath 250 tube shunts in lowering IOP in glaucoma patients.

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 recruiting trials for Glaucoma

Currently open trials in the same condition.

Other State University of New York at Buffalo trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT04542616.

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