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Dexamethasone nanoparticles eye…

Efficacy and Safety of Dexamethasone Nanoparticles Eye Drops in Diabetic Macular Edema

Ensayo de Oculis Holding AG en Edema macular diabetico.

Más ensayos de: Edema macular diabético.

Fase

Fase 2

Estado

Completado

Participantes

144

previstos

Centros

1

Fin del objetivo primario

mar 2019

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, doble ciego. Comenzó en sep 2017.

Qué mide

Mean Change in Early Treatment of Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) (Baseline & Week 12) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroAnti-inflammatory or anti-angiogenic drugs play an ever- increasing role in the treatment of diabetic macular edema (DME). The drug delivery systems, such as injections of corticosteroid and or vascular endothelial growth factor (VEGF) antibodies into the vitreous cavity or slow release drug capsules surgically implanted in the eyes run the risk of surgical complications including infections, hemorrhages and cataracts and place a huge demand on eye care resources significantly increase the risk of cardiovascular events and death. A non-invasive drug delivery platform with steroid eye drops, reaching the back of the eye to treat DME and other retinal diseases would circumvent most of these problems. A novel drug delivery platform is required for ocular therapy. Oculis ehf. has developed a drug delivery platform, which is based on cyclodextrin nanoparticles that dissolve in the tear fluid to form water-soluble drug/cyclodextrin complex nanoparticles. Animal and initial clinical testing has shown the potential for this technology to increase the drug concentration in the eye tissues including the retina and therefore treat retinal diseases like DME.

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Ficha completa en ClinicalTrials.gov (NCT05343156), actualizada en jun 2022.