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
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Topical Dexamethasone - Cyclodextrin Microparticle Eye Drops for Diabetic Macular Edema

Resource links provided by NLM:


Further study details as provided by King Saud University:

Primary Outcome Measures:
  • Best Corrected Visual Acuity on ETDRS chart [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intraocular pressure (IOP) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: March 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01523314

Locations
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    dr.abouammoh@gmail.com   
Sub-Investigator: Einar Stefánsson, MD         
Sub-Investigator: Phatsawee Jansook, PhD         
Sub-Investigator: Thorsteinn Loftsson, PhD         
Sponsors and Collaborators
King Saud University
  More Information

No publications provided

Responsible Party: Ahmed Abu El-Asrar, Professor, Consultant, Vitreoretinal/Uveitis division, King Saud University
ClinicalTrials.gov Identifier: NCT01523314     History of Changes
Other Study ID Numbers: DECEDE
Study First Received: January 28, 2012
Last Updated: January 31, 2012
Health Authority: Saudi Arabia: Institutional review Board at King Saud University

Keywords provided by King Saud University:
diabetic macular edema
intravitreal injection
dexamethasone
Cyclodextrin
eye drops
bevacizumab
macular laser

Additional relevant MeSH terms:
Macular Edema
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Signs and Symptoms
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Tetrahydrozoline
BB 1101
Ophthalmic Solutions
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014