Does oral administration of dabigatran etexilate, a direct thrombin inhibitor, achieve significant levels and thrombin inhibiting activity in the eye?

Does oral administration of dabigatran etexilate, a direct thrombin inhibitor, achieve clinical significant concentrations of dabigatran and thrombin inhibiting activity in vitreous and subretinal fluid? - Dabigatran & Ocular Accessibility

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000388-41-NL

Enrollment

Registered

2014-03-13

Start date

2014-05-05

Completion date

Unknown

Last updated

2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular accessibility of dabigatran in patients with retinal detachment

Interventions

Trade Name: Pradaxa(r) Pharmaceutical Form: Capsule, hard

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age = 18 years, - Informed consent, - Needing surgery for a rhegmatogenous retinal detachment (scleral buckle surgery or vitrectomy) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12

Exclusion criteria

Exclusion criteria: - Using other anticoagulants (e.g. acenocoumarol, heparin etc), - Using medication that increases risk of GI bleeding (e.g. aspirin, NSAID’s, SSRI’s, oral corticosteroids). - History of stomach ulcer/ bleeding - Patients with renal function (CrCL) 75 - Hepatic impairment, - Hypersensitivity to the active substance or to any of the excipients, - Concomitant treatment with systemic ketoconazole, cyclosporine, itraconazole, tacrolimus and dronedarone, - Lesion or condition at significant risk of major bleeding.

Design outcomes

Primary

Measure	Time frame
Main Objective: Quantifying dabigatran levels and thrombin inhibiting activity in the vitreous and subretinal fluid after oral administration of dabigatran etexilate in patiens with a retinal detachment.;Secondary Objective: Not applicable;Timepoint(s) of evaluation of this end point: During surgery;Primary end point(s): Levels of dabigatran in vitreous, subretinal fluid and plasma. Antithrombin activity in vitreous and subretinal fluid and plasma.	—

Measure

Time frame

Main Objective: Quantifying dabigatran levels and thrombin inhibiting activity in the vitreous and subretinal fluid after oral administration of dabigatran etexilate in patiens with a retinal detachment.;Secondary Objective: Not applicable;Timepoint(s) of evaluation of this end point: During surgery;Primary end point(s): Levels of dabigatran in vitreous, subretinal fluid and plasma. Antithrombin activity in vitreous and subretinal fluid and plasma.

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Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Netherlands

Contacts

Public ContactRotterdam Ophthalmic Institute

The Rotterdam Eye Hospital

r.wubbels@oogziekenhuis.nl31104023430

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026