Intravitreal versus submacular injection of rtPA for acute submacular haemorrhages. - rtPA for acute submacular haemorrhages
Phase 1
- Conditions
- acute submacular haemorrhage
- Registration Number
- EUCTR2010-023636-17-NL
- Lead Sponsor
- The Rotterdam Eye Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
- Informed consent
- Age > 45
- Submacular haemorrhage not existing longer than 14 days at time of surgery
- Thickness of SMH at least 1.0 mm
- If patient is on anticoagulant drugs: INR<2 (measured during preoperative holding)
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- INR>2 (or when treating cardiologist does not allow an INR<2)
- Known etiology of SMH other than exudative AMD
- Known serious allergy to fluorescein or indocyanine green dye
- Immunocompromised
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To examine which route of rtPA administration (submacular or intravitreal) is most effective with respect to dislocation and/or volume reduction of SMH at 3 months.;Secondary Objective: Safety and VA outcome.;Primary end point(s): - Location of haemorrhage at baseline and 3 months.<br>- Size of haemorrhage at baseline and 3 months.<br>- Safety at 3 months.<br>
- Secondary Outcome Measures
Name Time Method