Intravitreal versus submacular injection of rtPA for acute submacular haemorrhages.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25583

Enrollment

Registered

2012-03-19

Start date

2012-04-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Acute submacular haemorrhages.

Interventions

Study arm 1: Submacular rtPA with pars plana vitrectomy, intravitreal C3F8/air mixture and bevacizumab. Study arm 2: Intravitreal rtPA, C3F8 gas and bevacizumab.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Informed consent; 2. Age > 45; 3. Submacular haemorrhage not existing longer than 14 days at time of surgery; 4. A clinically relevant SMH that needs treatment; 5. If patient is on anticoagulant drugs: INR<2 (measured during preoperative holding).

Exclusion criteria

Exclusion criteria: 1. INR>2 (or when treating cardiologist does not allow an INR<2); 2. Known etiology of SMH other than exudative AMD; 3. Known serious allergy to fluorescein or indocyanine green dye; 4. Immunocompromised.

Design outcomes

Primary

Measure	Time frame
1. Location of haemorrhage at baseline and 6 weeks; 2. Size of haemorrhage at baseline and 6 weeks; 3. Safety at 6 weeks.	—

Secondary

Measure	Time frame
1. Location and size of haemorraghe at 12 weeks (at ophthalmologists' discretion); 2. Visual acuity (ETDRS chart) at baseline 6 and 12 weeks.	—

Contacts

Public ContactJ.C. Meurs, van

Oogziekenhuis Rotterdam, Schiedamsevest 180

vanMeurs@oogziekenhuis.nl+31 (0)10 4017777

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)