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Brian C Joondeph, Arshad M Khanani, Jay S Duker, David S Boyer, Jeffrey Heier, Peter K Kaiser, Mathew W MacCumber, Dante Joseph Pieramici; ORBIT: A Phase IV Clinical Study – Efficacy and Safety Outcomes From Ocriplasmin Intravitreal Injection. Invest. Ophthalmol. Vis. Sci. 2017;58(8):3703. doi: https://doi.org/.
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The Phase 4 ORBIT Study (NCT02079883) was designed to observe the clinical outcomes and safety of patients receiving ocriplasmin in a real-world setting for the treatment of symptomatic VMA/ VMT.
ORBIT, a large, multicenter, prospective, observational study enrolled 539 patients across 90 retina clinics throughout the US. Patients were ≥18 years, diagnosed with symptomatic VMA/ VMT and treated with ocriplasmin at the physician’s discretion in a manner consistent with the US product label. Data were collected at Baseline visit (BL - day of 2.5 mg/mL ocriplasmin injection, per standard of care) and postinjection visits (at the discretion of the treating physician), and entered into electronic case report forms, based on investigators’ assessment. Spectral-domain optical coherence tomography (SD-OCT) images were uploaded to the central reading center (CRC) for independent review. Clinical outcome measures and safety parameters were collected for up to 12 months postinjection.
Demographics were similar between those with VMA/VMT at BL (n=480) (per CRC) compared to all treated subjects (n=539); however, 10.9% (480/539) of all subjects did not have VMA/VMT based on the assessment of the CRC. Overall pharmacologic VMA/VMT resolution at Month 1 was 45.8% (220/480). Pharmacological VMA/VMT resolution improved over time to a rate of 59.0% (283/480) at Month 12. The FTMH closure rate was 30.5% (36/118) at Month 1 and 32.2% (38/118) at Month 12. Patients had a low rate of adverse drug reactions: 13.5% (73/539) experienced photopsia, 9.6% (52/539) vitreous floaters, and 6.7% (36/539) had reduced visual acuity. Serious adverse drug reactions were also low.
Overall VMA/VMT resolution at 1 month was higher than the MIVI-TRUST results (45.8% in ORBIT compared to 26.5% in MIVI-TRUST), demonstrating the importance of patient selection. No new safety signals were identified.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.
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