Patients with symptomatic vitreomacular adhesion (VMA) find that a single intravitreal injection of ocriplasmin improves their vision, according to an ancillary analysis of two multicentre randomised clinical trials reported in JAMA Opthalmology.
Until recently, the only treatment available for VMA was vitrectomy. Vitrectomy is effective but has the usual risks, complications, expense, inconvenience, and recovery time associated with surgery.
Ocriplasmin received EU approval in 2013 for the treatment of vitreomacular traction, including that associated with a macular hole up to 400 microns in diameter, and was launched in the UK in the same year. It is an injectable recombinant serine protease that acts by hydrolysing the proteins fibronectin and laminin, which are components of the extracellular matrix that mediates vitreoretinal adhesion.
Researchers from the Keck School of Medicine in Los Angeles, the University of Southern California Eye Institute in Los Angeles, Wills Eye Hospital in Philadelphia, and the Cole Eye Institute in Cleveland monitored patient-reported visual function in a 6-month follow-up to two multicentre, masked, placebo-controlled randomised clinical trials designed to test the efficacy and safety of a single intravitreal injection of ocriplasmin. In total, 652 patients with symptomatic VMA were included in the two studies, 464 of whom received the ocriplasmin injection and 188 who received a placebo injection.
Complete ophthalmological examinations, including optical coherence tomography to monitor the resolution of VMA, were performed before and at intervals after the ocriplasmin injection for a follow-up period of 6 months. Study investigators were permitted to recommend and perform vitrectomy at any point that the vision worsened, or if it had not improved within 4 weeks after the injection.
Patient-reported outcomes are increasingly being used in tandem with clinical end points to determine the value of treatment interventions in medicine in general and in ophthalmology specifically. The 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) was administered at examination visits to evaluate patients’ own perception of their visual function. This validated questionnaire, which is designed to take about 5 minutes to complete, is a short-form version of a longer survey that assesses vision-specific health-related quality of life.