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Jan Hendrik de Jong, Elsbeth J.T. van Zeeburg, Matteo Giuseppe Cereda, Mirjam EJ Van Velthoven, Koenraad Arndt Vermeer, Jan C. van Meurs; A randomized controlled trial comparing intravitreal versus subretinal injection of recombinant tissue plasminogen activator for displacement of acute submacular haemorrhage in AMD using SD-OCT volume measurements. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):3517.
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© ARVO (1962-2015); The Authors (2016-present)
Submacular haemorrhage (SMH) is a severe complication of AMD. Displacement of an SMH within 14 days is thought to be essential. Current management is towards administration of recombinant tissue plasminogen activator (rtPA) and gas. RtPA can be administered either intravitreal or subretinal, the latter combined with vitrectomy. In this pilot-study we compared the effectiveness of both administration routes.
Twenty-four patients with an acute SMH were randomized to either intravitreal injections of rtPA, C3F8 gas and bevacizumab (n=12) or vitrectomy with subretinal rtPA administration, C3F8 gas and intravitreal bevacizumab (n=12). Primary outcome measure was SMH volume change on SD-OCT in a 2.4 mm cylinder around the fovea at six weeks after treatment, scored by two masked observers. Subretinal blood, fluid and sub-RPE volume were analyzed separately. For statistical analysis non-parametric testing was performed (Mann-Whitney U test). Secondary outcome measures were visual acuity (VA) and complication rate.
In each group one patient was excluded from OCT and VA analysis at six weeks due to a retinal detachment (RD). Mean relative volume reduction of subretinal blood at six weeks was 91±13% in the intravitreal rtPA group and 95±10% in the subretinal rtPA group and did not differ significantly between groups (p=0.22). Subretinal fluid and sub-RPE blood volume was reduced in both groups without significant differences between groups. Mean ETDRS line difference from baseline six weeks post-op: 1.3±2.6 lines with intravitreal rtPA and 1.4±4.1 lines with subretinal rtPA. Complications were (intravitreal rtPA/subretinal rtPA): RD (1/2), recurrent SMH (1/1), IOP> 50 mmHg within 4 hours after injection (1/0), vitreous haemorrhage (2/0).
We did not find any significant differences in effectiveness between intravitreal and subretinal rtPA in this small RCT using our volumetric SMH analysis. This suggests that the combination of intravitreal rtPA with gas is not inferior to the combination of subretinal rtPA, vitrectomy and gas regarding blood volume reduction of an SMH in AMD. In both groups, visual acuity slightly increased and complications were substantial.
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