VMT MEDICAL TRIAL
From the Phase III clinical trial program, 5.4 percent ocriplasmin-treated patients had SRF with a median time to onset of eight days.
15 Subretinal fluid was temporally associated with ellipsoid zone layer disruption. The loss of the OS ellipsoid zone occurred by day five on average with a median time of resolution of 29 days. In our patients, the frequency of this outer retinal change was considerably higher. Outer segment ellipsoid zone (IS/OS junction) changes were not identified during the clinical trial program because time-domain OCT was used, while during the postmarketing period, the reported frequency was 0.2 percent (15 cases of photoreceptor alterations). The visual function changes were also associated with anatomic changes. ( See endnotes for additional citation information.) December 19, 2013.) Overall, ERG changes were generally transient (median time to resolution of six months) and correlated with dyschromatopsia. ( Ocriplasmin 2nd Periodic Benefit-Risk Evaluation Report. There were three cases of ERG changes reported from the post-marketing experience, with two exhibiting isoelectric responses. In this subset of patients who had baseline and post-injection ERGs, five of 13 (38.5 percent) showed abnormal changes from baseline, and all showed resolution by last follow-up. Only one of the Phase II trials, the MIVI-008 trial, had baseline and post-injection ERGs done in a subset of patients who received ocriplasmin. ERG changes included decreased a and b wave amplitudes with time to onset of Dyschromatopsia was noted in 1.7 percent of patients in the clinical trial program and in 0.4 percent from post-marketing experience. The reported frequency of visual impairment, according to the second periodic benefit-risk evaluation report for ocriplasmin (PBRER 2) was 1.8 percent, which included the following MedDRA terms: visual impairment metamorphopsia scotoma vision blurred visual acuity reduced visual acuity reduced transiently visual acuity tests abnormal visual field defect blindness (transient) visual brightness halo vision and loss of visual contrast sensitivity. A total of nine patients from the clinical trial program still had decreased visual acuity at month six, which in most cases was due to VMT or macular hole progression, or stemmed from vitrectomy complications. The time to onset was one to two days after injection and had a median time to resolution of 14 days. 12,13 The efficacy and safety of ocriplasmin was demonstrated by the Phase III MIVI-TRUST Study program that showed that overall, a single intravitreal injection of ocriplasmin (125 µg) resulted in a higher proportion of patients achieving VMA resolution (26.5 percent) at day 28 versus placebo (10.1 percent).Ī separate analysis of the Phase III trial data identified positive predictors of VMT resolution at day 28 including absence of an epiretinal membrane, VMA diameter ≤1,500 µm (focal adhesion), presence of FTMH ≤400 µm in width, phakic lens status and age two line decrease) were observed in 7.7 percent of patients during the clinical trial program by day seven. It is a novel truncated form of plasmin that enzymatically cleaves structural proteins at the vitreoretinal interface, leading to liquefaction and vitreous detachment. 6-11 Ocriplasmin is the only approved pharmacological treatment option for patients with symptomatic VMA/VMT. Untreated symptomatic VMA/VMT can lead to debilitating visual symptoms and is a risk factor for the development of full-thickness macular holes (FTMHs). Vitreomacular adhesion can progress to vitreomacular traction, a progressive degenerative disease, which results from incomplete posterior vitreous detachment.
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