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

January 31, 2012 updated by: Ahmed Abu El-Asrar, King Saud University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11411
        • College Of Medicine, King Saud University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Best Corrected Visual Acuity on ETDRS chart
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Intraocular pressure (IOP)
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Saud University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Anticipated)

August 1, 2012

Study Completion (Anticipated)

February 1, 2013

Study Registration Dates

First Submitted

January 28, 2012

First Submitted That Met QC Criteria

January 31, 2012

First Posted (Estimate)

February 1, 2012

Study Record Updates

Last Update Posted (Estimate)

February 1, 2012

Last Update Submitted That Met QC Criteria

January 31, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DECEDE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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