Topical Dexamethasone - Cyclodextrin Microparticle Eye Drops for Diabetic Macular Edema

Diabetic Macular Edema Clinical Trial

— DECEDE  

Official title:

Topical Dexamethasone - Cyclodextrin Microparticle Eye Drops for Diabetic Macular Edema

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01523314
• Other study ID #: DECEDE
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: January 28, 2012
• Last updated: January 31, 2012
• Start date: March 2012
• Est. completion date: February 2013

Study information

• Verified date: January 2012
• Source: King Saud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Institutional review Board at King Saud University
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: February 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

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.

Locations

Country	Name	City	State
Saudi Arabia	College of Medicine, King Saud University	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
King Saud University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best Corrected Visual Acuity on ETDRS chart		3 months	No
Secondary	Intraocular pressure (IOP)		3 months	Yes