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

Phase 1

• Conditions: Ocular accessibility of dabigatran in patients with retinal detachment; Therapeutic area: Body processes [G] - Ocular Physiological Phenomena [G14]

• Registration Number: EUCTR2014-000388-41-NL
• Lead Sponsor: The Rotterdam Eye Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-13
• Study Completion: 2015-04-22
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 28

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

-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) < 50 mL/min,
-Age > 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br>Antithrombin activity in vitreous and subretinal fluid and plasma.<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable