Treatment with a single ocriplasmin injection led to clinically meaningful improvements in the patient-reported visual function measured by the VFQ-25 questionnaire over 24 months in patients with symptomatic vitreomacular adhesion.
More patients with symptomatic vitreomacular adhesion (VMA)/vitreomacular traction including macular holes who were treated with Ocriplasmin (Jetrea, ThromboGenics) reported clinically relevant improvements in visual function on the Visual Function Questionnaire (VFQ-25) compared with sham-treated patients.
The assessment of the patient-reported visual function was the secondary endpoint of the Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole (OASIS) study.
“Outcomes from patient self-assessment are needed to understand if the improved clinical outcomes are translating into improved quality of life. The patient’s functional ability is as important as the clinical measure of VMA resolution,” Calvin Mein, MD, commented.
The VFQ-25 does just that, in that it measures the patient’s perceptions of their visual function as well as how the treatment affects their daily activities in relation to the visual function.
One intravitreal injection of ocriplasmin (0.125 mg) or sham treatment was administered to the patients in the OASIS study. The patients completed the VFQ-25 questionnaire at baseline and again at months 6, 12, and 24. The clinically meaningful changes, defined as 5-point or higher changes from baseline, were assessed.
The investigators reported their findings in Retina.1
A total of 220 patients participated in the OASIS study; of these, 146 had been treated with one injection of ocriplasmin and 74 patients with a sham injection. Two patients who were not evaluated after the injection were excluded from the analysis.
The patients in the active-treatment group fared better than those in the sham-treatment group, Mein noted.
Specifically, 51.4% of those treated with ocriplasmin achieved a 5-point or greater increase in the composite score of the VFQ-25 at the 2-year time point compared with baseline, while 30.1% of those in the sham-treated group achieved that score. The difference reached significance (p = 0.003).
In addition, fewer patients in the ocriplasmin group reported worsening of their visual function at the 2-year time point compared with the sham-treated group, i.e., 9.5% versus 15.6%, respectively; p = 0.191).
The investigators also considered the visual function based on the presence or absence of a full-thickness macular hole (FTMH) at baseline. At 2 years, with and without a FTMH, those treated with ocriplasmin did better than patients in the sham-treated group.
Specifically, a FTMH was present in 34.5% and 35.6% of patients in the ocriplasmin and sham groups at baseline, respectively, and 60% and 26.9%, respectively, of them had VFQ-25 composite scores of 5 points or higher compared with baseline (p = 0.006). In those patients without a FTMH, the respective percentages achieving a higher score were 46.3% and 31.9% (p = 0.101).
Analysis of decreases in the patient-reported visual function based on the FTMH presence or absence were similar, in that fewer patients in the ocriplasmin group had a 5-point or higher score decrease compared with the sham-treated group. The respective percentages with a FTMH were 6.0% and 11.5% and without a FTMH, 12.6% and 19.1%, neither of which reached significance (p = 0.396 and p = 0.303).
The nonsurgical symptomatic VMA resolved in 41.7% of patients treated with ocriplasmin and in 6.2% of those treated with sham by day 28 after the injection, the study found, and despite the presence of symptomatic VMA that did not resolve, the composite score improvements of 5 points or higher on the VFQ-25 were greater in the ocriplasmin group than in the sham group.
With VMA resolution, the percentages were 57.1% and 39.8%, respectively, p = 0.483; without VMA resolution, the percentages were 48.7% and 29.5%, respectively, p = 0.019). And fewer patients in the ocriplasmin group had a 5-point or greater worsening compared with the sham group (13.3% and 17.1%, respectively, p = 0.552), Mein noted.
The study concluded, “Treatment with a single ocriplasmin injection led to clinically meaningful improvements in the patient-reported visual function measured by the VFQ-25 questionnaire over 24 months in patients with symptomatic VMA.”