OR WAIT null SECS
Improvement in patients’ assessment of visual function was reported after treatment with intravitreal ocriplasmin for vitreomacular adhesion.
Take-home message: Improvement in patients’ assessment of visual function was reported after treatment with intravitreal ocriplasmin for vitreomacular adhesion.
By Fred Gebhart; Reviewed by Rohit Varma, MD
Los Angeles-Patients with symptomatic vitreomacular adhesion report that a new injectable drug, ocriplasmin (Jetrea, ThromboGenics), improves their vision.
The patient reported results were part of two ancillary analyses from a multinational clinical trial that showed positive clinical results.
“The key message is that ocriplasmin improves an individual’s assessment of their quality of life and vision-related function,” said lead author Rohit Varma, MD, Grace and Emery Beardsley Professor and Chairman, Department of Ophthalmology, University of Southern California (USC) Keck School of Medicine, and director, USC Eye Institute, Los Angeles.
“What we found was clinically meaningful improvement in patient’s self-reported ability to perform vision-related tasks,” Dr. Varma added.
The study was published earlier this year (Varma R et al. Improvement in patient-reported visual function after ocriplasmin for vitreomacular adhesion. JAMA Ophthalmol. Published online June 11, 2015).
The patient-reported outcomes were collected as part of the larger Microplasmin for Intravitreous Injection-Traction Release with Surgical Treatment (MIVI-TRUST) trials. The primary results of two multicenter trials conducted in Europe and the United states were published in 2012.
The clinical results showed that the enzymatic vitreolysis with ocriplasmin resolved vitreomacular traction and closed macular holes in significantly more patients compared with placebo. The drug was approved by the FDA in 2012 and is marketed as Jetrea by ThromboGenics, which sponsored both the clinical trials and the patient-reported outcomes analyses.
Next: "It is critically important that we know how the patients feel"
“It is critically important that we know how the patients feel they are functioning in their day-to-day activities after a particular treatment and whether they report any improvement,” Dr. Varma said.
“There are many things we do in ophthalmology, and in medicine in general, where we focus on specific aspects of the anatomy and/or function of an organ system,” he added. “What we have not been very good at is assessing the impact of disease on the person and assessing the impact of an intervention on the person and their ability to function as a person. We need to focus on the outcomes and aspects of treatments that truly make a difference in the lives of people.”
In the MIVI-TRUST patient-reported outcomes study, a total of 652 patients with symptomatic vitreomacular adhesion (VMA) or vitreomacular traction (VMT) were randomly assigned to either a single intravitreal injection of ocriplasmin (464 patients) or a placebo injection (188 patients). The primary outcome measure was means changes between baseline and 6 month follow-up on the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25). Mean improvement in the NEI VFQ-25 subscale scores of five points was considered a clinically meaningful improvement.
The mean improvement in NEI VFQ-25 scores at 6 months was significantly better in patients who received ocriplasmin than placebo, an increase of 3.4 points compared with an increase of 0.7 points (p = 0.005). Similar results were seen in subscore scales including vision-related dependency, driving difficulty, distance vision activities, and general vision.
A great proportion of patients who received ocriplasmin had an improvement of five points or more compared with placebo, 36% versus 27.2% (p = 0.03), as well as an increase of ten points or more, 21% versus 13% (p = 0.03). On the other side, fewer patients who received ocriplasmin had a decline in NEI VFQ-25 scores of five points or more, 15% versus 24.3% (p = 0.005).
Patients who had resolution of VMA as verified on OCT also reported significantly better results if they had received ocriplasmin. The mean improvement in NEI VFQ-25 scores at 6 months was 5.7 points for patients who received ocriplasmin and whose VMA resolved. The mean improvement for patients who received placebo and whose VMA resolved was 2.6 points.
Next: Patient-reported outcomes
Among patients who received placebo, there was no statistically significant difference in improvement in NEI VFQ-25 scores regardless of whether the VMA resolved. Even patients treated with ocriplasmin who did not achieve VMA release had higher improvement in most NEI VFQ-25 subscale scores at 6 months compared with patients who received placebo.
“At the end of the day, we can tell a patient that their vision improved by 2 lines, but we almost never ask what that means to the patient,” Dr. Varma said.
“We may declare victory because some treatment causes a statistically significant improvement in some measure that has absolutely no meaningful impact on the patient’s ability to live their everyday life,” he said. “We need to be asking those practical questions more often in our research and in our everyday practice.”
Patients’ own assessment of their progress also has a practical value, he continued.
Patients who sense progress and improvement show positive behavioral changes. They are more likely to be adherent to their regimen; they are more likely to schedule and keep return appointments; and they are more likely to undertake more physical activity and healthier eating patterns. When patients feel they are making progress from a particular drug or treatment, they are more likely to speak out in support when dealing with politicians, regulators, payers, and other stakeholders that may exert some degree of control over access and payment.
“Patient-reported outcomes are the most critical aspect of how beneficial or valuable a drug is,” Dr. Varma said. “There is a need for data on changes to the anatomy of the retina, but patient assessments of improvement in their vision is as important, if not more important, than clinical changes in determining the value of this new medication.”
Rohit Varma, MD
Dr. Varma did not indicate any proprietary interest in the subject matter.