Session Title: New Drug Treatment and Technology II
Session Date/Time: Sunday 20/09/2015 | 09:00-10:30
Paper Time: 10:20
First Author: : D.Steel UNITED KINGDOM
Co Author(s): :
PURPOSE:The safety profile and efficacy of ocriplasmin have been established in two phase III clinical studies, but the complete clinical profile of ocriplasmin has not been fully documented across different countries. The purpose of this study is to characterize baseline characteristics, safety profile, and clinical effectiveness of ocriplasmin in real-world settings across different countries.
Patients will include those prospectively enrolled from outpatient ophthalmology clinics in selected countries where ocriplasmin is marketed. Enrollment is ongoing throughout multiple study centers worldwide.
The INJECT trial is a non-interventional, multicenter, prospective study in vitreomacular traction (VMT) patients treated with ocriplasmin. Enrolled patients are followed for 12 months. Frequency and timing of post-injection visits are at the discretion of the treating physician. Patient baseline characteristics collected include age, race, gender, presence and size of macular hole (MH), presence of epiretinal membrane (ERM), and size of vitreomacular adhesion. Analyses of subgroups are limited to those patients who have available optical coherence tomography (OCT) data at baseline and reported data on variables. Safety assessments include ocular symptoms and adverse events.
The interim analysis included 140 patients. 94 patients had complete OCT data and at least 28 days of follow-up. Pharmacologic VMT resolution was achieved by 29.8% (n=28/94) of all patients in this group. For patients with baseline ERM data, the rate of pharmacologic VMT resolution was significantly higher among those without ERM at baseline (39.1%, n=25/64) compared to those with ERM at baseline (0.0%, n=0/7, P=.040). For patients who had baseline MH size data (N=34), the rate of pharmacologic VMT resolution was 33.3% (n=4/12) among those with small MH (≤250 um) and 66.7% (n=14/21) among those with medium MH (>250 to ≤400 μm). Additionally, the rate of MH closure was 18.2% (n=6/33) among those with MH size ≤ 400 μm; 25.0% (n=3/12) in those with <250 μm and 14.3% (n=3/21) in those with 250 to 400 μm MH size. Regarding safety, there were 4 retinal detachments (n=4/140, 2.9%) and 4 patients without MH at baseline developed a MH (n=4/64, 6.3%). The most frequently reported adverse events were vitreous floaters (n=7/140, 5.0%)and photopsia (n=7/140, 5.0%).
The interim results of this study suggest that ocriplasmin real-world clinical profile across different countries is consistent with safety and efficacy findings from the phase III clinical trials. Final study results will contribute to the further characterization of ocriplasmin efficacy, safety profile, and global treatment patterns.