Jeffrey Marx, M.D. ; Ophthalmology
A Pilot Study with Reduced Fluence Photodynamic Therapy with Visudyne in Combination With Ranibizumab VS. Ranibizumab Monotherapy for the Treatment of Exudative AMD
This physician initiated investigational trial will evaluate the safety and efficacy of combination-reduced fluence PDT and ranibizumab compared with ranibizumab alone in the treatment of subjects diagnosed with exudative age related macular degeneration. Combination reduced fluence PDT and ranibizumab has similar efficacy to ranibizumab alone. Combination therapy will reduce the number of intravitreal injections of ranibizumab over a 13-month period.
Combination therapy with PDT and Ranibizumab (Lucentis) was explored in a phase1/II trial of 162 subjects with predominantly classic subfoveal neovascularization. Subjects who received combination PDT and Lucentis were more likely to maintain vision than PDT alone. In addition, those undergoing combination therapy gained an average of 5 letters in visual acuity, while those in PDT only arm lost an average of 8 letters at 12 months.
In this pilot study subjects experiencing less than 15 letter decrease in vision from baseline in the study eye and greater than 15 letter increase in vision from baseline using the Early Treatment Diabetic Retinopathy Study (ETDRS) method will be measured, along with mean vision gain/loss from baseline (in ETDRS letters) the number of intravitreal injections of ranibizumab during the 13 month study period.
John Stoffel, M.D. ; Urology
Identification and Assessment of the Internal Urethral Sphincter with Electromyography During Bladder Neck Sparing Radical Retropubic Prostatecomy
Eligible subjects having open bladder neck preserving RRP will undergo EMG Identification of Internal Urinary Sphincter to access its function through a novel intra-operative EMG recording technique. The level of sphincteric EMG activity will then be correlated with postoperative urinary continence rates, as measured through validated urinary specific quality of life questionnaires.
Following removal of the prostate, the nerves connected to the bladder neck will be gently stimulated with a CaverMap™ Nerve Stimulator. The CaverMap device is FDA approved as a surgical aid for identifying and measuring the function of the inferior hypogastric nerve plexus during radical prostatectomy. Recordings from the bladder neck and urethral EMG electrodes will be made at 1,5,10, 15 and 20mAmps of stimulated current, the stimulation settings used per CaverMap™
Diana Apetauerova, MD: Neurology
Study of the Effectiveness of Coenzyme Q10 in Slowing Disease Progression in Patients with Progressive Supranuclear Palsy (PSP)
This multicenter, randomized, placebo controlled clinical trial was developed by Diana Apetauerova, MD and is sponsored by grants from the Society for PSP and Wise. The goal of this study is to compare the efficacy, safety and tolerability of Coenzyme Q10 versus placebo in patients with progressive supranuclear palsy (PSP). Progressive Supranuclear Palsy (PSP) is an atypical parkinsonian syndrome of unknown etiology, characterized by the accumulation of hyperphosphorylated tau protein in various parts of the brain. PSP can mimic idiopathic Parkinson's disease (PD) during initial presentation; however, atypical clinical features, lack of response to dopaminergic therapy and much poorer prognosis differentiate PSP from PD. Mitochondrial dysfunction has been suggested in the pathophysiology of PSP as well as many other neurodegenerative disorders, including idiopathic PD.
There is currently no effective treatment for PSP. Coenzyme Q10, which has been shown to be a beneficial therapy for PD, might also be beneficial for PSP. Efficacy of high doses of Coenzyme Q10 (2400mg/day) will be measured. We hope to enroll 60 subjects from several sites, including Beth Israel.
