PP-035 The treatment of submacular haemorrhage due to neovascular age related macular degeneration using intravitreal alteplase (rtPA): preparation and clinical outcomes of the off-label therapy

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Abstract

Background

Subretinal haemorrhage is a neovascular age related macular degeneration (AMD) complication and it causes decreased visual acuity (VA). No medical treatment is registered for the disease. The most widely used approach is vitrectomy. The hospital pharmacy of our centre has validated the operating procedure to prepare a sterile rtPA solution for intravitreal administration with a 0.5 mg/mL concentration. This solution is used ‘off-label’, with no therapeutic alternatives.

Purpose

This work aims to review the formulation development and evaluate the clinical ‘off-label’ treatment outcomes, to analyse the benefit–risk profile.

Material and methods

We investigated the rational use of the intravitreal formulation, prepared from Actilyse, by dilution with ppi water. We retrospectively examined medical records of patients who were treated from January 2006 to March 2012 and analysed the success in subretinal haemorrhage dislocation, VA variations in time (measured in logMar, inversely proportional to VA) and complications.

Results

78 injections in 76 patients (average age 79±7.9 years) were administered. The average VA (VAa) at baseline was 1.79±0.92 logMar. Basal VAa in patients who had been pretreated with anti-VEGF drugs corresponded to 1.58±0.92 logMar and the VAa of non-pretreated patients was 1.93±0.91 logMar. 1 month after treatment VAa decreased of 0.4 logMar compared with baseline. 6 months after treatment, 27/78 eyes had earned at least −0.6 logMar from baseline, and by 1 year after treatment 25/55 eyes. 37/78 eyes had a VA that allowed patient movement before treatment while 51/78 eyes allowed patient movement after 1 month of treatment and 39/55 eyes after 1 year.

Conclusion

The off-label use of intravitreal rtPA to treat subretinal haemorrhage was effective (it removed subretinal haemorrhage in 96.2% of patients and the VA trends were favourable in time). VAa increased significantly 1 month after treatment and it stabilised at better values compared with baseline. The intravitreal injections were also safe.

References and/or acknowledgements

Kamei, Tano, Maeno, et al. Surgical removal of submacular haemorrhage using tissue plasminogen activator and perfluorocarbon liquid. Am J Ophthalmol1996;121:267–75.

References and/or acknowledgements

No conflict of interest

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