NCT01523314

Topical Dexamethasone - Cyclodextrin Microparticle Eye Drops for Diabetic Macular Edema

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: King Saud University · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The research group has developed new ocular drug delivery technology based on cyclodextrin nanoparticles (NP). The investigators plan to develop and test this technology to help treat diabetic macular edema (DME). An important step in research was the invention of cyclodextrin nanoparticles, which has just received a US patent. The investigators pre-clinical and clinical work has demonstrated the investigators eye drop suspension with cyclodextrin nano-particles to be superior to conventional eye drops. They increase drug absorbance into the eye and decrease systematic distribution of the drug, hence reducing side effects. Cyclodextrin nanoparticle eye drops deliver drugs to the posterior part of the eye, thus solving one of the biggest obstacles in ocular pharmacology.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	dexamethasone - Cyclodextrin eye drops	The study eye will receive the dexamethasone NP eye drops 3 times a day for 3 months. The subject will be handed an eye drop bottle at each monthly visit for self administration of the eye drops. Each eye drop container is to be marked with a date when first opened and discarded after 1 week (unless it contains a preservative).
OTHER	intravitreal Avastin injection +/- macular laser	The study eye will receive standard laser and intravitreal injections of Avastin for 3 months. Complete eye examination will be performed prior to drug administration.

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-08-01
• Completion: 2013-02-01
• First posted: 2012-02-01
• Last updated: 2012-02-01

Locations

1 site across 1 country: Saudi Arabia