Topical Dexamethasone - Cyclodextrin Microparticle Eye Drops for Diabetic Macular Edema (DECEDE)
Recruitment status was: Not yet recruiting
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.
|Diabetic Macular Edema||Drug: dexamethasone - Cyclodextrin eye drops Other: intravitreal Avastin injection +/- macular laser||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Topical Dexamethasone - Cyclodextrin Microparticle Eye Drops for Diabetic Macular Edema|
- Best Corrected Visual Acuity on ETDRS chart [ Time Frame: 3 months ]
- Intraocular pressure (IOP) [ Time Frame: 3 months ]
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||February 2013|
|Estimated Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
|Experimental: dexamethasone - Cyclodextrin||
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).
|Active Comparator: Avastin/Laser||
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01523314
|College of Medicine, King Saud University||Not yet recruiting|
|Riyadh, Saudi Arabia, 11411|
|Contact: Ahmed A Abu El-Asrar, MD, PhD 0096614786100 ext 1430 abuasrar@KSU.EDU.SA|
|Contact: Marwan A Abouammoh, MD 00966505476426 firstname.lastname@example.org|
|Sub-Investigator: Einar Stefánsson, MD|
|Sub-Investigator: Phatsawee Jansook, PhD|
|Sub-Investigator: Thorsteinn Loftsson, PhD|