Conditions: Diabetic Macular Edema
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 144
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: The study eye received 1 DexNP eye drop 3 times a day (every 8 hours) for 12 weeks. arm 2: The study eye received 1 vehicle eye drop 3 times a day (every 8 hours) for 12 weeks.

Interventions: intervention 1: Dexamethasone nanoparticles eye drops
Intervention descriptions: intervention 1: DexNP 15 mg/mL eye drops 3 times a day (every 8 hours) for 12 weeks

Protocol document:
Prot_SAP_000.pdf: