Topical Dexamethasone - Cyclodextrin Microparticle Eye Drops for Diabetic Macular Edema

NCT01523314 | Unknown Phase 2 DMC

• 1 other identifier: DECEDE
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Macular Edema

Keywords

diabetic macular edema; intravitreal injection; dexamethasone; Cyclodextrin; eye drops; bevacizumab; macular laser

Outcome Measures

Primary Outcomes (1)

• Best Corrected Visual Acuity on ETDRS chart

  3 months

Secondary Outcomes (1)

• Intraocular pressure (IOP)

  3 months

Study Arms (2)

dexamethasone - Cyclodextrin

EXPERIMENTAL

Drug: dexamethasone - Cyclodextrin eye drops

Avastin/Laser

ACTIVE COMPARATOR

Other: intravitreal Avastin injection +/- macular laser

Interventions

dexamethasone - Cyclodextrin eye drops DRUG

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).

dexamethasone - Cyclodextrin

intravitreal Avastin injection +/- macular laser OTHER

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.

Avastin/Laser

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King Saud University: lead

Study Sites (1)

College of Medicine, King Saud University

Riyadh, Riyadh Region, 11411, Saudi Arabia

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Consultant, Vitreoretinal/Uveitis division

Study Record Dates

• First Submitted: January 28, 2012
• First Posted: February 1, 2012
• Study Start: March 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: February 1, 2013
• Last Updated: February 1, 2012

Record last verified: 2012-01

Locations

SA (1)