Topical Dexamethasone - Cyclodextrin Microparticle Eye Drops for Diabetic Macular Edema (DECEDE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01523314|
Recruitment Status : Unknown
Verified January 2012 by Ahmed Abu El-Asrar, King Saud University.
Recruitment status was: Not yet recruiting
First Posted : February 1, 2012
Last Update Posted : February 1, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Macular Edema||Drug: dexamethasone - Cyclodextrin eye drops Other: intravitreal Avastin injection +/- macular laser||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Topical Dexamethasone - Cyclodextrin Microparticle Eye Drops for Diabetic Macular Edema|
|Study Start Date :||March 2012|
|Estimated Primary Completion Date :||August 2012|
|Estimated Study Completion Date :||February 2013|
|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.
- Best Corrected Visual Acuity on ETDRS chart [ Time Frame: 3 months ]
- Intraocular pressure (IOP) [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 email@example.com|
|Sub-Investigator: Einar Stefánsson, MD|
|Sub-Investigator: Phatsawee Jansook, PhD|
|Sub-Investigator: Thorsteinn Loftsson, PhD|