NCT01523314|UnknownPhase 2/3DMC
Topical Dexamethasone - Cyclodextrin Microparticle Eye Drops for Diabetic Macular Edema
DECEDE
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DECEDE
Sponsor study identifier
interventional
40
1 country
1
Study Start
March 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 28, 2012
Actual (reported)February 1, 2012
Actual (reported)March 2012
Date type not reportedThis date has not been verified as actual or estimated.
August 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Best Corrected Visual Acuity on ETDRS chart
3 months
Intraocular pressure (IOP)
3 months
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).
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.
College of Medicine, King Saud University
Riyadh, Riyadh Region, 11411, Saudi Arabia
First Submitted
January 28, 2012
First Posted
February 1, 2012
Study Start
March 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2012
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 1, 2012
Record last verified: 2012-01
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Source: ClinicalTrials.gov.
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