Topical Dexamethasone - Cyclodextrin Microparticle Eye Drops for Diabetic Macular Edema (DECEDE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by King Saud University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Ahmed Abu El-Asrar, King Saud University
ClinicalTrials.gov Identifier:
NCT01523314
First received: January 28, 2012
Last updated: January 31, 2012
Last verified: January 2012

January 28, 2012
January 31, 2012
March 2012
August 2012   (final data collection date for primary outcome measure)
Best Corrected Visual Acuity on ETDRS chart [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01523314 on ClinicalTrials.gov Archive Site
Intraocular pressure (IOP) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Topical Dexamethasone - Cyclodextrin Microparticle Eye Drops for Diabetic Macular Edema
Topical Dexamethasone - Cyclodextrin Microparticle Eye Drops for Diabetic Macular Edema

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetic Macular Edema
  • 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.
  • Experimental: dexamethasone - Cyclodextrin
    Intervention: Drug: dexamethasone - Cyclodextrin eye drops
  • Active Comparator: Avastin/Laser
    Intervention: Other: intravitreal Avastin injection +/- macular laser
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
40
February 2013
August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetes mellitus
  • Pseudophakic in study eye, i.e. with IOL (intra ocular lens) after cataract surgery
  • Diabetic macular edema with central macular thickness over 300 µm on OCT in study eye. If both eyes have DME, then the treatment will be applied to the eye with thicker central macula on OCT.
  • Age 18 years or older

Exclusion Criteria:

  • Glaucoma or use of any glaucoma medication
  • Known steroid IOP response
  • Any infectious eye disease
  • Treatment for DME within 6 months, such as laser treatment, intravitreal or subtenon injections of steroids, intravitreal injections of anti vascular endothelelial growth factor medication.
  • Any eye surgery within 3 months or other eye conditions e.g. corneal disorders, ocular hypotony and retinal detachments.
  • Crystalline lens present in study eye
  • Known allergy to cyclodextrins, dexamethasone, ranibizumab or any of the components of the study medications
Both
20 Years to 70 Years
No
Saudi Arabia
 
NCT01523314
DECEDE
Yes
Ahmed Abu El-Asrar, King Saud University
King Saud University
Not Provided
Not Provided
King Saud University
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP