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K Bailey Freund; OZONE: Ocriplasmin Ellipsoid Zone Retrospective Data Collection Study. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):1219.
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© ARVO (1962-2015); The Authors (2016-present)
Safety and efficacy of ocriplasmin to treat symptomatic vitreomacular adhesion (VMA), was established in phase 3 clinical trials using time-domain optical coherence tomography (TD-OCT) to assess retinal anatomy. Using spectral domain optical coherence tomography (SD-OCT) allows observation and measurement of subtle retinal changes and enables more accurate monitoring of disease progression and response to therapy. A Phase 4 study was designed to retrospectively review and further characterize anatomic and symptomatic changes, using SD-OCT, following treatment of VMA with JETREA® (ocriplasmin).
The Phase 4 OZONE study will include 200 patients from ~30 US sites. Anatomic and symptomatic changes over 6-months in patients treated with ocriplasmin for VMA and imaged with SD-OCT. Images will be masked and uploaded to a Central Reading Center (CRC) for review and analysis. The primary endpoint is the proportion of patients with ellipsoid zone disruption by Day 21 post-ocriplasmin injection, which was not present at baseline. Secondary endpoints include: incidence, time to onset and/or resolution of ellipsoid zone disruption, subretinal fluid development, VMA status, macular hole changes, vitrectomy, visual acuity changes from baseline and adverse drug reactions (Table 1).
As of 11/12/14, preliminary data from 52 patients at 11 clinics were available. Preliminary data on baseline characteristics include: mean age: 71 years; gender: 61.5% female; baseline lens status in study eye: phakic= 67%, pseudophakic= 33%, and aphakic=0%; baseline visual acuity in study eye (Snellen) 20/40 or better=29%, 20/50-20/80=52%, and 20/100 or worse= 17%, 10/200= 2%; injection position: supine=83%, sitting=2%, sitting at 45°=12%.
The OZONE study utilizing SD-OCT in post-ocriplasmin patients will further characterize anatomic and symptomatic changes post-ocriplasmin. Data from the full population and image analysis will be available.
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