Patient-reported vision improved by ocriplasmin

July 1, 2015

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.

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.

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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.

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The ocriplasmin-treated group reported a greater mean improvement from baseline compared with the placebo group both in composite NEI VFQ-25 score and across several relevant subscales including vision-related dependency, driving difficulty, distance vision activities, and general vision. Subscales such as colour vision and vision-related social function were not considered to be relevant to this study as they tend to be unaffected by VMA: baseline scores resembled those seen previously in healthy subjects and, as expected, the scores did not change with treatment.

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More patients in the ocriplasmin group noticed a clinically meaningful improvement in their vision than in those who were given placebo. Similarly, they were less likely to experience worsening function than patients randomised to receive placebo.

Complete VMA resolution was achieved in 26.5% of ocriplasmin-treated patients at day 28. Mean NEI VFQ-25 composite score was significantly improved in these patients compared with those in whom VMA did not resolve, but even those patients whose VMA did not resolve experienced improvements in most subscale scores compared with patients who had received placebo. This was expected to be the case, as even partial VMA release can improve visual function.

Better vision was experienced by more ocriplasmin-treated patients who achieved closure of a macular hole than those who did not.

The researchers concluded that clinically meaningful improvements in patient-reported visual function, demonstrated using the NEI VFQ-25 composite score and that of various subscales, can be achieved without surgery in patients with symptomatic VMA.