To investigate whether oral administration of dabigatran etexilate in patients with a rhegmatogenous retinal detachment leads to clinical significant dabigatran levels and thrombin inhibiting activity in the vitreous and subretinal fluid.
ID
Source
Brief title
Condition
- Eye disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Dabigatran levels and thrombin inhibiting activity in the vitreous or
subretinal fluid.
Secondary outcome
Dabigatran level in plasma.
Background summary
Coagulation factor thrombin is thought to play an important role in the
development of proliferative vitreoretinopathy (PVR). The direct thrombin
inhibitor dabigatran is therefore an interesting potential drug candidate.
Study objective
To investigate whether oral administration of dabigatran etexilate in patients
with a rhegmatogenous retinal detachment leads to clinical significant
dabigatran levels and thrombin inhibiting activity in the vitreous and
subretinal fluid.
Study design
Pilot drug intervention study.
Intervention
Dabigatran etexilate (Pradaxa®) 220 mg once.
Study burden and risks
During surgery, a vitreous or subretinal fluid sample (residual material) will
be taken, and a blood sample. Bleeding risk is thought to be negligible as only
one dose of 220 mg dabigatran etexilate is administered and patients with
increased risk of bleeding are excluded. There are no specific benefits for the
patient.
Schiedamse Vest 180
Rotterdam 3011 BH
NL
Schiedamse Vest 180
Rotterdam 3011 BH
NL
Listed location countries
Age
Inclusion criteria
- Age >= 18 years,
- Informed consent,
- Needing surgery for a rhegmatogenous retinal detachment (scleral buckle surgery or vitrectomy)
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-000388-41-NL |
| CCMO | NL48418.078.14 |
| OMON | NL-OMON23085 |