#Vmt retina trial#

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).

If you have any questions or want to learn more about the current ongoing trials, please fill out the form below or call our office at 81/31 and speak with our Clinical Research Coordinator, Fadi Shaya.Vitreomacular adhesion can progress to vitreomacular traction, a progressive degenerative disease, which results from incomplete posterior vitreous detachment. Objective: To obtain estimates of the proportion of eyes with Macular Hole closure of the inner retinal layers for eyes with Vitreomacular Traction (VMT) and full-thickness Macular Holes treated with Pneumatic Vitreolysis (PVL). Trial 4: Single-Arm Study Assessing the Effects of Pneumatic Vitreolysis on Macular Hole (Protocol AH) Objective: To compare the proportion of eyes with foveal VMT release on OCT after pneumatic vitreolysis with gas injection versus observation (sham injection) in eyes with VMT without an associated macular hole. Trial 3: Randomized Clinical Trial Assessing the Effects of Pneumatic Vitreolysis on Vitreomacular Traction (Protocol AG) Objective: To compare the efficacy of intravitreous aflibercept (Eylea) with intravitreous bevacizumab (Avastin) + deferred aflibercept if needed in eyes with Centrally-Involved Diabetic Macular Edema and moderate vision loss. Trial 2: Randomized Trial of Intravitreous Aflibercept versus Intravitreous Bevacizumab + Deferred Aflibercept for Treatment of Central-Involved Diabetic Macular Edema (Protocol AC)

and Bayer AG) in subjects with neovascular AMD (wet AMD). Objective: The purpose of this clinical study is to evaluate the effectiveness and safety of 0.5 mg and 1.0 mg dose levels of conbercept intravitreal (IVT) injection as compared to the approved VEGF antagonist active control, aflibercept intravitreal (IVT) injection (2.0 mg/eye, Eylea®, Regeneron Pharmaceuticals, Inc. Trial 1: A Multicenter, Double-Masked, Randomized, Dose Ranging Trial to Evaluate the Efficacy and Safety of Conbercept Intravitreal Injection in Subjects with Neovascular Age-related Macular Degeneration

Vmt retina