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A randomized controlled trial comparing intravitreal versus subretinal injection of recombinant tissue plasminogen activator for displacement of an acute submacular haemorrhage in age-related macular degeneration

Session Details

Session Title: Vitreo Retinal Surgery I

Session Date/Time: Thursday 11/09/2014 | 08:00-10:00

Paper Time: 08:16

Venue: Auditorium

First Author: : E.J.Van Zeeburg THE NETHERLANDS

Co Author(s): :    H. de Jong   M.G Cereda   M.E.J. van Velthoven   K.A. Vermeer   J.C. van Meurs  

Abstract Details

Purpose:

Submacular haemorrhage (SMH) is a severe complication of age-related macular degeneration (AMD). If untreated, the SMH itself will cause irreversible damage to the retina and retinal pigment epithelium (RPE). Displacement of an SMH by administration of recombinant tissue plasminogen activator (rtPA) and gas is generally believed to improve outcome compared to monotherapy of anti-VEGF injections. rtPA can be administered either intravitreal or subretinal, the latter combined with vitrectomy. Currently the trend is towards subretinal administration, however intravitreal administration might be as effective and might cause less complications. In this pilot-study we examine the safety and effectiveness of both administration routes.

Setting:

Single-center randomized controlled trial (RCT).

Methods:

Twenty-four patients with an acute submacular haemorrhage were randomized to either intravitreal injections of C3F8 gas, rtPA and bevacizumab (n=12) or vitrectomy with subretinal rtPA administration, C3F8 gas and intravitreal bevacizumab (n=12). Inclusion criteria: history of onset of haemorrhage less than 14 days at time of surgery, haemorrhage size thicker than the retina but thinner than the maximum height (750 micron) imaged on spectral-domain Optical Coherence Tomography (SD-OCT). Primary outcome measure was blood displacement on SD-OCT at six weeks after treatment. This was scored by two masked observers on horizontal and vertical sections and classified as: total, subtotal, half, minimal, no displacement. Both subretinal and subRPE blood were analysed separately. For statistical analysis non-parametric testing (Mann-Whitney U) was performed. Secondary outcome measurements were visual acuity (VA) pre- and six weeks postoperatively and the complication rate.

Results:

Preoperative VA in the intravitreal rtPA group: median 0.76, range 0.42-1.62 logMAR. Six weeks postoperatively: median 0.64, range 0.10–1.68 logMAR. Mean Early Treatment Diabetic Retinopathy Study (ETDRS) lines increase: 0.91 (range -4 - +10). Preoperative VA in the subretinal rtPA group: median 0.75, range 0.06-1.44 logMAR. Six week postoperatively: median 0.48, range 0.32-1.14 logMAR. Mean ETDRS lines increase: 1.09 (range -3 - + 4). Total displacement six weeks after treatment of subretinal blood in the intravitreal rtPA group was found in 6/11 (horizontal scan) and 5/11 (vertical scan) patients respectively, whereas in the subretinal rtPA with vitrectomy group total displacement was found in 10/11 (both horizontal and vertical) patients; p=0.07 and p=0.03 respectively. In the intravitreal rtPA group subtotal displacement was found in 5/11 (horizontal) and 6/11 (vertical) patients; and in 1/11 patients in the subretinal rtPA group (both horizontal and vertical). Total displacement of subRPE blood was ≤ 20% in both groups; p=0.16 (horizontal) and p=0.49 (vertical). Complications: Intravitreal rtPA: retinal detachment (RD) (1), recurrent SMH (1), IOP> 50 mmHG within 4 hours after injection (1), vitreous haemorrhage (2). Subretinal rtPA: RD (2), recurrent SMH (1).

Conclusions:

Our qualitative analysis in this small RCT suggests that the combination of vitrectomy, subretinal rtPA and bevacizumab was more successful in complete displacement of subretinal blood, but not of sub-RPE blood. The combination of intravitreal rtPA, gas and bevacizumab was also effective in displacing the haemorrhage, but more often a residue remains. The achieved subtotal displacement may also be sufficient to improve the VA. Complications in this small study are serious. A quantitative, more precise volumetric data analysis may reveal differences not detected by the qualitative, more traditional comparison reported in this abstract. A larger trial would be needed to establish difference in effect on visual outcome and complication rate in both groups.

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