22 results
The goal of the trial is to compare the efficacy and costs of bevacizumab 1.25 mg and ranibizumab 0.5mg given as monthly intravitreal injections over 6 months for the treatment of macular edema secondary to a retinal vein occlusion.
To describe the pharmacokinetic (PK) profile and effectiveness of sarilumab in patients with pcJIA in order to identifythe dose and regimen for continued development in this population.
see section 21 & 2.2This trial aims to prove the concept of induction of mucosal healing by BI 655130 add-ontherapy in patients with mild or moderate ulcerative colitis and persisting endoscopic activitydespite pre-existing TNFi treatment.…
The goal of the trial is to compare the efficacy and costs of bevacizumab 1.25 mg and ranibizumab 0.5mg given as monthly intravitreal injections over 6 months for the treatment of diabetic macular edema.
The goal of the trial is to investigate the safety and efficacy of SAR566658, if it is provided to CA6 protein positive metastaticTBN breastcancer patients.
The main objective of the study is to determine the PK and PD of IVIg during maintenance treatment in patients with CIDP. These data will be used to conduct a NONMEM analysis in relation to the dosage, frequency and batch of IVIg used. The secondary…
Primary objective:To demonstrate that an individualized stabilization-criteria-driven PRN dosingregimen (PRN) with 0.5-mg ranibizumab administered with or without adjunctive lasertreatment has superior efficacy as compared to the current standard of…
Primary: to evaluate the effectiveness of two treatment regimens by assessing the average stable maximum best-corrected (BCVA) change from Month 4 to Month 12 compared to Month 3. A treatment regimen will be considered a relevant treatment option if…
The primary objective is to determine whether subjects with CIDP are overtreated with maintenance IVIg treatment and to reduce overtreatment-associated subjects* burden and health care costs.
Primary: to compare the treatment effect of ranibizumab PRN (visual acuity loss and/or SD-OCT disease activity guided retreatment) versus aflibercept bimonthly regimen on central retinal thickness stability as measured by mean fluctuations between…
the main objectives of the study are to evaluate the efficacy of different doses of BI655066 + to evaluate the pharmacokinetics (how the body handles the study drug) and pharmacokinetics (interaction of the study drug with the body) for subjects…
To evaluate the safety and efficacy of abicipar (2 mg), compared to 0.5 mg ranibizumab in treatment-naïve patients with neovascular AMD.
The primary objective is:1. To investigate whether high frequency low dosage IVIg treatment is more effective than low frequency high dosage as maintenance treatment for CIDP. Secondary objectives are:2. To investigate whether high frequency low…
This study has two parts. The main purpose of Part 2 of this study is to see how safe and effective different doses of BI 655064 are as well as to look at the pharmacokinetics (the amount of medication in your blood) and the pharmacodynamics (the…
Primary: To demonstrate that intravitreal injection of 0.5 mg ranibizumab administered based on individual patient needs has superior efficacy compared to sham treatment in adult patients with visual impairment due to VEGF-driven ME. Secondary: Best…
The overall purpose of the trial is to assess clinical efficacy and safety of three different doses of BI 655066 administered by multiple subcutaneous injections in adult patients with defined ankylosing spondylitis. We will also explore its…
The primary objective is to evaluate the efficacy of an individualized stabilization criteriadrivenPRN dosing regimen with 0.5 mg ranibizumab as assessed by the mean best-corrected visualacuity (BCVA) change at Month 12 compared to Baseline.
Primary objective:To demonstrate that the mean change from baseline in Best Corrected Visual Acuity (BCVA) over a 12 month treatment period obtained with either a 0.5 mg ranibizumab *Treat and Extend* (TE) dosing regimen with adjunctive laser, and/…
To compare visual outcome and foveal function after (initiation of) treatment between patients receiving an RPE-choroid graft and patients with anti-VEGF medication.
Primary objectiveTo assess the efficacy of intravitreally (ITV) administered VEGF Trap-Eye compared to ranibizumab (in a non-inferiority paradigm) in preventing moderate vision loss in subjects with all subtypes of neovascular AMD Secondary…