16 results
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/…
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 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 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…
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…
To compare visual outcome and foveal function after (initiation of) treatment between patients receiving an RPE-choroid graft and patients with anti-VEGF medication.
The objective of this study is to assess the efficacy of skin anesthesia using fractional laser assisted delivery of articaine hydrochloride 40 mg/ml and epinephrine 10 µg/ml solution compared to standard anesthesia with topical eutectic mixture of…
The primary objectives of the present study are to compare the effect of pretreatment with two different fractional laser modalities (CO2 and Er:YAG laser) on topical anesthesia and to compare the anesthetic effect of two different topical…
The purpose of the study is to investigate the ability of MYL-1401H to evoke an immune response (immunogenicity) as compared to Neulasta® US. In addition, the effect of MYL-1401H on blood cells as compared to Neulasta® US will be investigated. The…
The primary objective of this study is to assess the analgesic effect of fractional carbon dioxide laser assisted delivery of two topical anesthetics (articaine hydrochloride 40 mg/ml and epinephrine 10 µg/ml solution (AHES) and eutectic mixture of…
The purpose of the study is to investigate how quickly and to what extent MYL-1401H is absorbed and eliminated from the body (this is called pharmacokinetics) as compared to Neulasta® EU and US. It will also be investigated what the effect is of MYL…
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 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 evaluate the safety and efficacy of abicipar (2 mg), compared to 0.5 mg ranibizumab in treatment-naïve patients with neovascular AMD.
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…