Intravitreal versus submacular injection of rtPA for acute submacular haemorrhages. - rtPA for acute submacular haemorrhages

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-023636-17-NL

Enrollment

Registered

2010-11-02

Start date

2012-03-15

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

acute submacular haemorrhage

Interventions

Trade Name: Actilyse Product Name: Actilyse Product Code: RVG 15228 Pharmaceutical Form: Powder and solvent for solution for injection Trade Name: Actilyse Pharmaceutical Form: Powder and solvent for

Eligibility

Sex/Gender

All

Inclusion criteria

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=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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. - Size of haemorrhage at baseline and 3 months. - Safety at 3 months.	—

Countries

Netherlands

Outcome results

None listed

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