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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. 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
Information provided by (Responsible Party):
Ahmed Abu El-Asrar, King Saud University

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: dexamethasone - Cyclodextrin eye drops Other: intravitreal Avastin injection +/- macular laser Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Best Corrected Visual Acuity on ETDRS chart [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Intraocular pressure (IOP) [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01523314

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Saudi Arabia
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   
Sub-Investigator: Einar Stefánsson, MD         
Sub-Investigator: Phatsawee Jansook, PhD         
Sub-Investigator: Thorsteinn Loftsson, PhD         
Sponsors and Collaborators
King Saud University

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Responsible Party: Ahmed Abu El-Asrar, Professor, Consultant, Vitreoretinal/Uveitis division, King Saud University Identifier: NCT01523314     History of Changes
Other Study ID Numbers: DECEDE
First Posted: February 1, 2012    Key Record Dates
Last Update Posted: February 1, 2012
Last Verified: January 2012
Keywords provided by Ahmed Abu El-Asrar, King Saud University:
diabetic macular edema
intravitreal injection
eye drops
macular laser
Additional relevant MeSH terms:
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Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Dexamethasone acetate
Ophthalmic Solutions
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances