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

Sponsor

King Saud University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01523314

Collaborator

(none)

Enrollment

Location

Arms

11.1

Duration (Months)

3.6

Patients Per Site Per Month

Study Details

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.

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

Study Design

Study Type:

Interventional

Anticipated 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 :

Mar 1, 2012

Anticipated Primary Completion Date :

Aug 1, 2012

Anticipated Study Completion Date :

Feb 1, 2013

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Best Corrected Visual Acuity on ETDRS chart [3 months]

Secondary Outcome Measures

Intraocular pressure (IOP) [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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