25 results
To investigate safety and tolerability and to collect exploratory efficacy data of long-term treatment with Org 50081 in adult patients with chronic primary insomnia.
Primary objective* To evaluate ocular and non-ocular adverse events during the 24-months study period in patients treated with Lucentis (0.5 mg)Secondary objectives* To describe the ocular and non-ocular adverse events over a cumulative 36-months…
Primary objectiveto demonstrate superiority of ranibizumab 0.5 mg as adjunctive or mono-therapy to laser treatment in the mean change from baseline in BCVA over a 12-month treatment period.Secondary objectives* to evaluate whether ranibizumab (0.5…
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: To demonstrate the long-term efficacy of treatment with Org 50081, as compared to placebo, on sleep maintenance in patients with chronic primary insomnia as measured by the subjective Total Sleep Time. Primary efficacy endpoint is the…
Primary • To investigate the safety and tolerability of long-term treatment with 1.5 mg or 3.0 mg of Org 50081 in elderly outpatients with chronic primary insomnia. Secondary • To collect exploratory efficacy data of long-term treatment with Org…
The primary objective of this study is to estimate the incidence of ocular adverse events in patients with CNV secondary to AMD who receive an individualized treatment with ranibizumab 0,3 mg.
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…
Het objectives of the study are to demonstrate that combination therapy of Lucentis and Visudyne is not inferior in effectivity and safety to monotherapy with Lucentis and to investigate whether less Lucentis injections in combination therapy with…
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: 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…
Primary: To compare the proportion of patients demonstrating Major Molecular Response (MMR) at 12 months (48 weeks) in the bosutinib arm with that of the imatinib arm in newly diagnosed Philadelphia chromosome positive (Ph+) chronic phase (CP)…
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…
To evaluate the safety and efficacy of abicipar (2 mg), compared to 0.5 mg ranibizumab in treatment-naïve patients with neovascular AMD.
The objectives of the current study are:1. To allow long term bosutinib treatment in patients with chronic or advanced phases of Ph+ CML who received bosutinib in a previous Pfizer sponsored CML study (i.e., studies B1871006 and B1871008) and who…
Primary: To compare the Major Molecular Response (MMR) rate at 24 weeks of ABL001 versus bosutinibSecondary: To compare additional parameters of the efficacy of ABL001 versus bosutinib. Safety, tolerability.
Primary: To assess the proportion of patients with intervention failure at 12 months after dose reduction, defined as patients who have restarted their initial dose due to (expected) loss of major molecular response.
Primary:To compare the efficacy of asciminib versus Investigator selected TKI with respect to the proportion of patients that are in Major Molecular Response at Week 48. To compare the efficacy of asciminib versus Investigator selected TKI, within…
This study will evaluate the effectiveness and safety of a 36-week refill regimen for the PDS with ranibizumab 100 mg/mL (PDS Q36W) compared with intravitreal injections of aflibercept (2 mg) administered per a treat-and-extend regimen (aflibercept…
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…