10 Oct Results of the 2-Year Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole (OASIS) Randomized Trial
MedicalResearch.com Interview with:
Dr. Pravin Dugel
Pravin U. Dugel, MD
Retina Consultants of Arizona
Phoenix, Arizona; USC Roski Eye Institute
Keck School of Medicine
University of Southern California
Los Angeles, California
MedicalResearch.com: What is the background for this study?
Response: OASIS is an acronym for “OcriplASmIn for Treatment for Symptomatic Vitreomacular Adhesion including Macular Hole”. It was a Phase IIIB, randomized, prospective, sham-controlled, double-masked, multicenter clinical study. The goal of the study was to further evaluate the long-term (24 months) efficacy and safety of a single injection of 0.125mg of ocriplasmin in patients with symptomatic vitreomacular adhesion (VMA) and vitreomacular traction (VMT), including macular hole (MH).
OASIS evaluated 220 patients with symptomatic VMA/VMT. One hundred forty-six patients received ocriplasmin while 74 served as a sham control group. In the latter group, no intravitreal injection was administered.
MedicalResearch.com: What are the main findings?
Response: Overall, OASIS demonstrated a pharmacological VMA/VMT release rate at Day 28 (the primary endpoint) of 41.7% in the ocriplasmin vs. 6.2% in the sham group (p<0.001). While macular hole greater than 400 µm and presence of epiretinal membrane were exclusion criteria, some patients with these conditions were inadvertently included by the investigator. When patients with a macular hole greater than 400 µm and epiretinal membrane at baseline as assessed by the CRC were excluded, the percentage increased to 47.7% at Day 28 in the ocriplasmin group, and 7.5% in the sham group.
MedicalResearch.com: What should readers take away from your report?
Response: Treating with ocriplasmin was superior to “observation,” which the sham group represented.
One of its principal strengths is that OASIS contains baseline data and had a two-year follow up. The OASIS study provides the largest sample size to date where long-term efficacy and safety of ocriplasmin, as well as natural disease history of symptomatic VMA/ VMT, were assessed in a prospective, standardized manner. This differentiates it from several published anecdotal case reports where baseline data and long-term evaluation is typically lacking.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Evaluation of the patient’s anatomical and functional results from ocriplasmin must be measured in weeks to months rather than days. The abnormalities seen at baseline in many of the parameters listed above would suggest that in some patients VMA/VMT and even MH produce a pan-retinal deficit. The fact that many of these parameters improve after ocriplasmin would suggest that this enzyme has a positive effect not only on function and structure, but also in the patient’s quality of life.
OASIS had many counterintuitive findings like abnormal ERGs being associated with improved BCVA and greater VMA release compared to normal ERGs. Patients with SRF at baseline tend to have a higher rate of VMA release than those without SRF. The exact mechanism in not clear for these counterintuitive findings.
MedicalResearch.com: Is there anything else you would like to add?
Response: The JETREA® safety profile in this 2-year follow-up study was consistent with the overall safety profile as known from the approved label, and makes it a reasonable alternative to vitrectomy and observation for carefully selected patients. No new types of safety events were identified. The majority of suspected adverse reactions were ocular in nature, mild to moderate in severity, had a short time to onset, and were transient. No drug-related late onset events were identified. Natural disease history has likely contributed to the long-term outcome of some suspected adverse reactions that did not resolve by end of study.
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Citation:
Ophthalmology. 2016 Oct;123(10):2232-47. doi: 10.1016/j.ophtha.2016.06.043. Epub 2016 Aug 4.
Results of the 2-Year Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole (OASIS) Randomized Trial.
Dugel PU1, Tolentino M2, Feiner L3, Kozma P4, Leroy A4.
Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.
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Last Updated on October 10, 2016 by Marie Benz MD FAAD