No registrations found.
ID
Source
Health condition
Acute submacular haemorrhages.
Sponsors and support
PO Box 70030
3000 LM Rotterdam
Intervention
Outcome measures
Primary outcome
1. Location of haemorrhage at baseline and 6 weeks;
2. Size of haemorrhage at baseline and 6 weeks;
3. Safety at 6 weeks.
Secondary outcome
1. Location and size of haemorraghe at 12 weeks (at ophthalmologists' discretion);
2. Visual acuity (ETDRS chart) at baseline 6 and 12 weeks.
Background summary
Rationale:
Submacular haemorrhage (SMH) is a severe complication of age-related macular degeneration (AMD). Anti-VEGF injections, the current standard treatment for exudative AMD, appear to be ineffective when a (large) SMH is present. If untreated, the SMH itself will cause irreversible damage to the retina and retinal pigment epithelium (RPE). Two treatment modalities of SMH will be compared.
Objective:
To examine which administration route of recombinant tissue plasminogen activator (rtPA) is safe and effective.
Study design:
Prospective, randomized, explorative intervention study.
Study population:
Consecutive patients with SMH existing ¡Ü 14 days at time of surgery.
Intervention:
Study arm 1: Submacular rtPA with pars plana vitrectomy (ppV), intravitreal C3F8/air mixture and bevacizumab.
Study arm 2: Intravitreal rtPA, C3F8 gas and bevacizumab.
Main study parameters:
Location and size of haemorrhage at 6 weeks.
Safety, Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
It is not clear, in advance, whether intravitreal or subretinal administration of rtPA is superior with respect to efficacy and safety. It is assumed that the minimally invasive treatment has a smaller effect on resorption and/or relocation of the blood but involves a lower risk of complications, while the maximally invasive treatment has a stronger effect on the SMH but involves a higher risk of complications. There will be 7 visits involving study-related assessments for both study arms: i.e. pre-operative, surgery, post-operative day 1, week 2, 4, 6, 12.
Study objective
Submacular administration of rtPA for submacular haemorrhages is safe and effective.
Study design
Baseline, day 0, day 1, weeks 2, 4, 5, 6, 10 and 12.
Intervention
Study arm 1: Submacular rtPA with pars plana vitrectomy, intravitreal C3F8/air mixture and bevacizumab.
Study arm 2: Intravitreal rtPA, C3F8 gas and bevacizumab.
Schiedamsevest 180
J.C. Meurs, van
Schiedamsevest 180
Rotterdam 3011 BH
The Netherlands
+31 (0)10 4017777
vanMeurs@oogziekenhuis.nl
Schiedamsevest 180
J.C. Meurs, van
Schiedamsevest 180
Rotterdam 3011 BH
The Netherlands
+31 (0)10 4017777
vanMeurs@oogziekenhuis.nl
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3208 |
| NTR-old | NTR3359 |
| Other | METC OZR / CCMO : 2010-22 / NL34560.078.10; |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |