Active clinical trials for "Macular Degeneration"

This multicenter study will investigate the safety, tolerability, pharmacokinetics, and immunogenicity of RO7303359 following single intravitreal (ITV) injection in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Participants will receive an ITV injection of RO7303359 in the single ascending dose stage and the maximum tolerated dose (MTD) or maximum tested dose (MTeD) of RO7303359 in the expansion stage.

This is an open-label, dose-escalating, 48-week study assessing the safety, tolerability, bioactivity and duration of action of a single intravitreal injection of 0.1 mg, 0.25 mg, or 0.5 mg AXT107 in approximately 18 subjects (up to 6 subjects per dose) with nAMD.

The study is designed to identify the maximum tolerated dose (MTD) for intravitreal (IVT) administration of GEM103 in subjects with geographic atrophy (GA) secondary to dry AMD. Safety and tolerability of a single dose of GEM103 will be assessed based on the occurrence of dose-limiting toxicities (DLTs). Each subject will be followed for safety, pharmacokinetic (PK), clinical, and biomarker evaluations. Three escalating dose cohorts are planned.

Purpose and rationale: To demonstrate similar efficacy, safety and immunogenicity of SOK583A1 and Eylea EU as per Eylea approved treatment regimen in patients with nAMD. The primary clinical question of interest is: Does SOK583A1 have similar efficacy as Eylea EU in terms of mean change in BCVA score in participants with nAMD who are anti-VEGF naive, without important protocol deviations and adherent to the treatment and completed the treatment to Week 8?

First-in-Human Study of the Safety of AR-13503 Sustained Release Intravitreal Implant in Subjects with Neovascular Age-Related Macular Degeneration (nAMD) and Subjects with Diabetic Macular Edema (DME)

Age-related macular degeneration (AMD) is the leading cause of irreversible visual impairment in Western Countries. It is a well-established fact that vascular endothelial growth factor (VEGF) plays a key part in the development of the neovascular (or exsudative) form of AMD. Today, VEGF-inhibition by means of injection of anti-VEGF agents into the vitreous cavity constitutes the gold standard of AMD therapy. In physiological conditions, VEGF acts as a vasodilator by activating endothelial nitric oxide synthase. As a consequence, VEGF inhibition should result in significant ocular vasoconstriction, which has in fact been demonstrated for bevacizumab and ranibizumab, two of the three available VEGF-inhibitors. The understanding and awareness of potentially harmful implications of the induced vasoconstriction on retinal and/or optic nerve head structure and function is sparse. This is especially delicate, as most patients with exsudative AMD require repeated injections on a monthly basis for many years. Aflibercept, the latest anti-VEGF agent approved for intravitreal use in 2011, offers a superior binding affinity for VEGF compared to the former two drugs. However, as of today, its effect on ocular circulation is unclear. With Laser Speckle Flowgraphy (LSFG), a commercially available, non-invasive and patient-friendly method for the evaluation of blood flow at the optic nerve head, the choroid and retina has arisen in recent years. We aim to measure ocular perfusion with LSFG before and after 3 consecutive injections of aflibercept in unilateral neovascular age-related maculopathy.

The purpose of this clinical study is to evaluate the safety and efficacy of cooling anesthesia application to the eye as anesthesia for intravitreal injection using a novel cooling anesthesia device and determine the effects of temperature and duration of application on subjective pain after intravitreal injection.

Study GR40548 is a Phase III, randomized, multicenter, open-label (visual assessor [VA]-masked), active-comparator study designed to assess the efficacy, safety, and pharmacokinetics (PK) of 100mg/ml delivered via the Port Delivery System with ranibizumab (PDS) compared with ranibizumab intravitreal injections at 0.5 mg (10 mg/mL) in participants with neovascular age-related macular degeneration (nAMD).

This study will evaluate the efficacy, safety, durability, and pharmacokinetics of faricimab administered at intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with neovascular age-related macular degeneration (nAMD).

To assess the safety of intravitreal Zimura™ (complement factor C5 inhibitor) administered in combination with Lucentis® 0.5 mg in treatment naïve subjects with neovascular age related macular degeneration (NVAMD)