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

King Saud University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Diabetic Macular Edema

Treatments: Drug: dexamethasone - Cyclodextrin eye drops; Other: intravitreal Avastin injection +/- macular laser

Study type: Interventional

Funder types: Other

Identifiers

NCT01523314

DECEDE

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

dexamethasone - Cyclodextrin

Experimental group

Treatment:

Drug: dexamethasone - Cyclodextrin eye drops

Avastin/Laser

Active Comparator group

Treatment:

Other: intravitreal Avastin injection +/- macular laser