CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 144 enrolled
Drug / intervention
Dexamethasone nanoparticles eye dropsdrug
Likely dose
Dexamethasone nanoparticles eye drops 15 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05343156
NCT05343156Phase 2Completed

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

Oculis·interventional·Posted Apr 25, 2022·Updated Jun 28, 2022

In Brief

A Phase 2 clinical trial evaluating Dexamethasone nanoparticles eye drops for Diabetic Macular Edema. Completed, enrolled 144 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesDenmark
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedApr 25, 2022
Enrollment StartSep 18, 2017
Primary CompletionMar 28, 2019
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 4.2 years ago

Interventions

Dexamethasone nanoparticles eye dropsdrug

DexNP 15 mg/mL eye drops 3 times a day (every 8 hours) for 12 weeks