22 results
Primary: To provide metastatic colorectal cancer patients with access to aflibercept and todocument the overall safety in these patientsSecondary: To document the Health-Related Quality of Life of aflibercept in this patientpopulation
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 determine the pharmacokinetics of posaconazole (new solid oral and IV) given as prophylaxis to patients who are at risk for developing fungal infections after receiving conditioning therapy (except strictly non myeloablative (NMA)) for…
The primary objective of this study is to evaluate the PK of POS administered orally at three dosage levels to immunocompromised children with expected neutropenia (selected oncology patients, aplastic anemia patients and patients which undergo a…
To examine features of treatment response on optical coherence tomography in patients who were switched to aflibercept after non-response to previous intravitreal anti-VEGF treatment.
Primary: Dose finding for a twice daily regimen for PSZ as prophylactic treatment in children with CGD, based on the exposure to PSZ measured by PSZ trough levels.Secondary:To determine the tolerability of PSZ as prophylactic treatment in children…
Primary: To determine the influence of posaconazole on unboosted fosamprenavir pharmacokinetics, and vice versa, in healthy volunteersSecondary: To determine the safety of combined use of fosamprenavir with posaconazole in healthy vol-unteers
Primary:• To demonstrate that RTH258 6 mg is not inferior to aflibercept 2 mg with respect to the change in best-corrected visual acuity (BCVA) from Baseline to Week 48Secondary:• To demonstrate that RTH258 6 mg is not inferior to aflibercept 2 mg…
To deliver proof of concept that antifungal prophylaxis with posaconazole in addition to standard of care (SOC) can reduce the incidence of IAA in ICU patients with severe influenza, in comparison with SOC alone.To assess differences in cytokine…
Primary objective:To determine the effect of obesity (BMI > 35 kg/m2) on the pharmacokinetics of posaconazole and develop a dosing regimen for obese patients. Secondary objective:• To describe the pharmacokinetics of the augmented dose of 400…
The aim of this study is to analyse the analgetic effect of a local injection in the lateral femoral cutaneous nerve ( LFCN) with methylprednisolone/lidocaine (M/L) after localisation through elektro stimulation VS placebo. In this trial we hope to…
The purpose of this study is to confirm how well aflibercept works in babies with ROP, comparing it with laser therapy. The study also has the objective to demonstrate how safe aflibercept is when used in babies. We will also learn how the drug…
This extension study aims to collect long-term data on safety and efficacy in a subject population treated for ROP with aflibercept and/or laser, and to contribute to the clarification of potential effects.
The purpose of this study is to investigate how safe and effective the new drug conbercept given as intravitreal injections (*study drug*) is when compared with Eylea® injections in patients with neovascular *wet* age-related macular degeneration (…
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…
In this study we want to find out how safe and effective is the new product brolucizumab. Brolucizumab is administered in this study to subjects with decreased sight due to diabetes macular edema. The effects of brolucizumab are compared with those…
Primary* To explore the pharmacokinetics of insulin aspart after pulsed intra-vaginal delivery using the MedRing and after subcutaneous injection in women with DM1.Secondary* To assess the safety and short-term tolerability of insulin aspart after…
The purpose of this study is to investigate the efficacy, safety, durability, and pharmacokinetics of faricimab administered at up to 16-week intervals to treatment-naive patients with nAMD.
To evaluate the efficacy and safety of brolucizumab used in a Treat-to-Control (TtC) regimen for the treatment of patients with neovascular age-related macular degeneration (nAMD) with the objective to evaluate the potential to reduce treatment…
To determine the efficacy of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 2.0 mg aflibercept, in participants with neovascular AMD.