Intravitreal versus submacular injection of rtPA for acute submacular haemorrhages.

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.

Submacular administration of rtPA for submacular haemorrhages is safe and effective.

Baseline, day 0, day 1, weeks 2, 4, 5, 6, 10 and 12.

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

Study arm 2: Intravitreal rtPA, C3F8 gas and bevacizumab.