Efficacy and Safety of Dexamethasone Nanoparticles Eye Drops in Diabetic Macular Edema
Status:
Completed
Trial end date:
2019-03-28
Target enrollment:
Participant gender:
Summary
Anti-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.