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

Primary Purpose

Diabetic Macular Edema

Status
Unknown status
Phase
Phase 2
Locations
Saudi Arabia
Study Type
Interventional
Intervention
dexamethasone - Cyclodextrin eye drops
intravitreal Avastin injection +/- macular laser
Sponsored by
King Saud University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring diabetic macular edema, intravitreal injection, dexamethasone, Cyclodextrin, eye drops, bevacizumab, macular laser

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • College of Medicine, King Saud University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

dexamethasone - Cyclodextrin

Avastin/Laser

Arm Description

Outcomes

Primary Outcome Measures

Best Corrected Visual Acuity on ETDRS chart

Secondary Outcome Measures

Intraocular pressure (IOP)

Full Information

First Posted
January 28, 2012
Last Updated
January 31, 2012
Sponsor
King Saud University
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1. Study Identification

Unique Protocol Identification Number
NCT01523314
Brief Title
Topical Dexamethasone - Cyclodextrin Microparticle Eye Drops for Diabetic Macular Edema
Acronym
DECEDE
Official Title
Topical Dexamethasone - Cyclodextrin Microparticle Eye Drops for Diabetic Macular Edema
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
August 2012 (Anticipated)
Study Completion Date
February 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Saud University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
diabetic macular edema, intravitreal injection, dexamethasone, Cyclodextrin, eye drops, bevacizumab, macular laser

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
dexamethasone - Cyclodextrin
Arm Type
Experimental
Arm Title
Avastin/Laser
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
dexamethasone - Cyclodextrin eye drops
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
intravitreal Avastin injection +/- macular laser
Intervention Description
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 Measure Information:
Title
Best Corrected Visual Acuity on ETDRS chart
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Intraocular pressure (IOP)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
College of Medicine, King Saud University
City
Riyadh
ZIP/Postal Code
11411
Country
Saudi Arabia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed A Abu El-Asrar, MD, PhD
Phone
0096614786100
Ext
1430
Email
abuasrar@KSU.EDU.SA
First Name & Middle Initial & Last Name & Degree
Marwan A Abouammoh, MD
Phone
00966505476426
Email
dr.abouammoh@gmail.com
First Name & Middle Initial & Last Name & Degree
Einar Stefánsson, MD
First Name & Middle Initial & Last Name & Degree
Phatsawee Jansook, PhD
First Name & Middle Initial & Last Name & Degree
Thorsteinn Loftsson, PhD

12. IPD Sharing Statement

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Topical Dexamethasone - Cyclodextrin Microparticle Eye Drops for Diabetic Macular Edema

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